High-Risk MelanomaPhase 2NCT00273910
Evaluation of the Impact of Adjuvants Accompanying Peptide Immunization in High-Risk Melanoma
A Phase 2 study testing gp100:209-217 (210M), Montanide ISA-51 and Imiquimod in people with High-Risk Melanoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This study will evaluate the immunization effects of a vaccine for patients who are at risk for recurrence of their skin cancer. That is, the risk of cancer is higher if melanoma has invaded deep into the skin or lymph nodes. Currently, the only therapy that the U.S. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- High-Risk Melanoma
- What is being tested?
- gp100:209-217 (210M), Montanide ISA-51 and Imiquimod
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to May 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HLA-A 0201 patients, age greater than or equal to 16 years, primary melanomas with lesions that are ulcerated and greater than or equal to 2mm, or any lesions that are greater than or equal to 4.0 mm in thickness, or greater than or equal to1 positive lymph node, or local recurrence, or resected metastatic disease, within 6 months of surgical resection will be considered. Patients must be clinically disease free at the time of protocol entry as documented by radiologic studies within 6 weeks of patient entry.
- Serum creatinine of 2.0 mg/dl or less
- Total bilirubin 1.6 mg/dl or less, except for patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.
- WBC 3000/mm^3 or greater,
- Platelet count 90,000 mm^3 or greater,
- Serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than three times normal,
Show all 9Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patients of both genders must be willing to practice effective birth control during this trial because the potential for teratogenic effects are unknown.
- Patients may have had prior adjuvant treatment with immunotherapy, including interferon, as long as 3 weeks have elapsed since prior systemic therapy.
Who cannot join
- Patients will be excluded:
- Who have ocular or mucosal melanoma.
- Who are undergoing or have undergone in the past 3 weeks any systemic therapy except surgery for their cancer, and must have recovered to a grade I from any adverse effects of treatment prior to entry, other than those that do not have clinical implications, e.g. vitiligo, alopecia.
- Have active systemic infections, autoimmune disease or any known immunodeficiency disease.
- Who require systemic steroid therapy.
- Who are pregnant (because of possible side effects on the fetus) or breastfeeding because of unknown effects on the developing child).
Show all 11Show fewer
- Who are known to be positive for hepatitis BsAG or human immunodeficiency virus (HIV) antibody (because of possible immune effects of these conditions).
- Who have any form of autoimmune disease (such as autoimmune colitis or Crohn's Disease) or immunodeficiency as evidenced by abnormal white blood count (WBC) count 8 and/or presence of opportunistic infections. Must have recovered immune competence after radiation therapy. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)
- Who have previously been immunized with gp100.
- Who have known hypersensitivity to any of the agents used in this study.
- Who have previously received chemotherapy for treatment of melanoma.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Official title: Evaluation of the Impact of Adjuvants Accompanying Peptide Immunization in High Risk Melanoma
This study will evaluate the immunization effects of a vaccine for patients who are at risk for recurrence of their skin cancer. That is, the risk of cancer is higher if melanoma has invaded deep into the skin or lymph nodes. Currently, the only therapy that the U.S. Food and Drug Administration (FDA) has approved for preventing recurrence of melanoma is alpha-interferon. But the research data are controversial. In this study, the vaccine to be used, called gp100, contains a piece of a protein called a peptide, which melanoma cancer cells produce.
Patients 16 and older who have had confirmed melanoma surgically removed and whose tissue type is tested as being human leukocyte antigen serotype within HLA-A serotype group (HLA-A2), through a specific blood test, may be eligible for this study.
Read more
Up to 132 participants will be enrolled. There will be a physical examination and collection of blood samples for tests, and making sure that x-rays and scans are current. Patients will be randomly assigned to four groups. Group 1 will receive the peptide with an adjuvant (assistant) oil-based liquid called Montanide ISA-51, as an injection in the thigh. Group 2 will receive gp100, Montanide, and a cream called imiquimod, which the FDA has approved for treating genital warts and herpes but that may help immune cells in the skin to recognize the vaccine. Imiquimod will be applied to the skin for 5 days. Group 3 will receive gp100 mixed in salt water given as several mini-doses under the skin of the thigh. Group 4 will also receive several mini-doses of gp100 mixed in saline, as well as imiquimod cream applied to the skin for 5 days. All patients will receive the gp100 every 3 weeks for 12 weeks. Every dose is a cycle, with four cycles considered a course of therapy. If the melanoma does not return or patients do not experience side effects from this therapy, then the courses of vaccine will repeated for up to 12 cycles of therapy (3 courses over 33 weeks). Side effects of the peptide vaccination include local swelling, swelling of local lymph nodes, bruising, and pain and redness at the injection sites. There may be chills or fever. Patients will be watched closely for such side effects.
To study how the vaccine changes the action of cells in the immune system, patients' white blood cells (lymphocytes) will be obtained, involving a separate informed consent. The procedure, called leukaphersis, requires inserting a needle into the arm, to obtain blood going into a machine, which divides the blood into red cells, plasma (or the serum part), and lymphocytes. The lymphocytes are removed, and the plasma and red cells returned to the patient through a second needle in the other arm. Risks associated with the procedure include fainting, which can be prevented by patients' eating before coming to the lab, and bleeding and infection at the needle site. Patients will undergo leukapheresis will be done about four times: before receiving the vaccine, 3 weeks after the first four doses, and then after 8 cycles and 12 cycles. Patients assigned to the groups receiving imiquimod will be asked to record every time they apply that cream and describe any symptoms developed during the study. All patients will be watched closely for any sign that their melanoma has returned. Before and throughout the study, multiple blood tests will be conducted.
The vaccine, Montanide, and imiquimod may increase patients' immune system in fighting off new tumors, but that is not known now. However, the study may provide information that will be useful in treating melanoma patients in the future.
Read the detailed description
Background:
A previous clinical trial has been conducted in the Surgery Branch National Cancer Institute (NCI) in which gp100 immunizations have been administered to patients with melanoma in the adjuvant setting. In this prior protocol, the peptide emulsified in Incomplete Freund's Adjuvant was administered subcutaneously using several different schedules and was well tolerated except for mild and transient erythema at the site of injection. Each of the schedules provided successful immunization although the q3w schedule was the best tolerated locally and three courses of immunization appeared to be sufficient using this regimen. An important finding from the adjuvant protocol however was the significant increase in immune precursors specifically reactive against peptide and tumor that occurred with increasing courses of immunization. These findings have encouraged us to now further explore the optimal methods for generating immune precursors using the gp100:209-217(210M) peptide by testing the impact of an additional immune adjuvant, imiquimod, reported to increase the immunizing potential of antigens as well as evaluate an alternate route of injection, intradermal administration.
Objectives:
The primary objective of this trial is to evaluate the immunologic activity of immunization with four different preparations of the gp100:209-217(210M) melanoma antigen peptide and potentially select one for further study.
Eligibility:
HLA-A 0201 patients, age greater than or equal 16 years, with primary melanomas with lesions that are ulcerated and greater than or equal 2mm, or any lesions that are greater than or equal 4.0 mm in thickness, or greater than or equal 1 positive lymph node, or local recurrence, or resected metastatic disease, within 6 months of surgical resection will be considered. Patients who have ocular or mucosal melanoma or who require systemic steroid therapy will be excluded. The following patients will also be excluded: have previously been immunized with gp100; have known hypersensitivity to any of the agents used in this study; have previously received chemotherapy for treatment of melanoma; or who are undergoing or have undergone in the past 3 weeks any systemic therapy except surgery for their cancer.
Design:
Patients will be randomized into one of the following four arms:
- gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
- gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
- gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
- gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
Immunizations will be administered on an outpatient basis unless side effects or the patient's clinical condition warrants hospitalization. Patients will receive full clinical evaluation three weeks after 8 cycles and 12 cycles.
Each of the arms will be conducted using a two-stage optimal design Since the primary objective is to select one regimen from among the four on the basis of the immune response, this design allows there to be greater than 80% probability of correctly selecting the superior arm if there is either a tie in the number of immune responses, or if there is at least one more immune response on one arm than the other three arms, and if the true response rates are 15%, 15%, 15% and 35%. Initially, 19 patients will be enrolled in each arm and evaluated; if 0 to 3 of 19 in an arm have an immune response to T2 cells pulsed with 0.01 M peptide after the 4th, 8th, and 12th cycles, no further patients would be randomized to receive the peptide on that arm. If at least four immunologic responses are noted after the 8th cycle, then accrual to 33 patients would take place. If all four arms need to be completed and 33 patients need to be completed in each arm, a total of 132 patients are required.
- Conditions
- High-Risk Melanoma
- Being tested
- gp100:209-217 (210M), Montanide ISA-51, Imiquimod
- Keywords
- Disease Free Survival, gp 100:209-217 (210m), Immunologic Response, Adjuvant Therapy, Cutaneous Melanoma, Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gp100:209-217 (210M)Drug
Montanide ISA-51Drug
ImiquimodDrug
Also called Aldara
Apply imiquimod 5% cream to the skin at the site of injection daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Adj-3 A2 gp209(2M) in IFA SQ (vortex) | Experimental | gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks). Receives: Drug: gp100:209-217 (210M); Drug: Montanide ISA-51 |
| Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (vortex) | Experimental | gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days. Receives: Drug: gp100:209-217 (210M); Drug: Montanide ISA-51; Drug: Imiquimod |
| Adj-3 A2 gp209(2M) in saline ID | Experimental | gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks). Receives: Drug: gp100:209-217 (210M) |
| Adj-3 A2 gp209(2M) in saline ID + Imiquimod | Experimental | gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days. Receives: Drug: gp100:209-217 (210M); Drug: Imiquimod |
| Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe) | Experimental | gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks). Receives: Drug: gp100:209-217 (210M); Drug: Montanide ISA-51 |
| Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe) | Experimental | gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days. Receives: Drug: gp100:209-217 (210M); Drug: Montanide ISA-51; Drug: Imiquimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunologic Response Rate
Comparison of six different preparations of the gp100:209-217 (210M) melanoma antigen peptide. The arm with the greater number of immunologic responses will be the one most likely to be selected for future study on the basis of immunization alone. Evidence of immunization consist of at least 10 Elispots/100,000 cells above background. An injection site reaction is not an immune response.
Measured: 48 months
Secondary outcomes (1)
Number of Participants With Adverse Events
Here are the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High-Risk MelanomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Steven Rosenberg, National Institutes of Health Clinical Center (CC)
- Investigators
- Steven A Rosenberg, M.D., Principal investigator, National Cancer Institute, National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273910
- Sponsor's protocol ID
- 060069
- Other IDs
- 06-C-0069
- Status last verified
- Oct 2012
- First submitted
- 7 Jan 2006
- Last updated
- 19 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kawakami Y, Eliyahu S, Delgado CH, Robbins PF, Rivoltini L, Topalian SL, Miki T, Rosenberg SA. Cloning of the gene coding for a shared human melanoma antigen recognized by autologous T cells infiltrating into tumor. Proc Natl Acad Sci U S A. 1994 Apr 26;91(9):3515-9. doi: 10.1073/pnas.91.9.3515.
PubMed 8170938
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Adjuvants Accompanying Peptide Immunization in High Risk Melanoma
- ClinicalTrials.gov ID
- NCT00273910
- Acronym / sponsor ID
- 060069
- Conditions
- High-Risk Melanoma
- Keywords
- Disease Free Survival, gp 100:209-217 (210m), Immunologic Response, Adjuvant Therapy, Cutaneous Melanoma, Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jan 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 9 Jan 2006 (estimated)
- Results
- Posted 14 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the immunization effects of a vaccine for patients who are at risk for recurrence of their skin cancer. That is, the risk of cancer is higher if melanoma has invaded deep into the skin or lymph nodes. Currently, the only therapy that the U.S. Food and Drug Administration (FDA) has approved for preventing recurrence of melanoma is alpha-interferon. But the research data are controversial. In this study, the vaccine to be used, called gp100, contains a piece of a protein called a peptide, which melanoma cancer cells produce.
Patients 16 and older who have had confirmed melanoma surgically removed and whose tissue type is tested as being human leukocyte antigen serotype within HLA-A serotype group (HLA-A2), through a specific blood test, may be eligible for this study.
Up to 132 participants will be enrolled. There will be a physical examination and collection of blood samples for tests, and making sure that x-rays and scans are current. Patients will be randomly assigned to four groups. Group 1 will receive the peptide with an adjuvant (assistant) oil-based liquid called Montanide ISA-51, as an injection in the thigh. Group 2 will receive gp100, Montanide, and a cream called imiquimod, which the FDA has approved for treating genital warts and herpes but that may help immune cells in the skin to recognize the vaccine. Imiquimod will be applied to the skin for 5 days. Group 3 will receive gp100 mixed in salt water given as several mini-doses under the skin of the thigh. Group 4 will also receive several mini-doses of gp100 mixed in saline, as well as imiquimod cream applied to the skin for 5 days. All patients will receive the gp100 every 3 weeks for 12 weeks. Every dose is a cycle, with four cycles considered a course of therapy. If the melanoma does not return or patients do not experience side effects from this therapy, then the courses of vaccine will repeated for up to 12 cycles of therapy (3 courses over 33 weeks). Side effects of the peptide vaccination include local swelling, swelling of local lymph nodes, bruising, and pain and redness at the injection sites. There may be chills or fever. Patients will be watched closely for such side effects.
To study how the vaccine changes the action of cells in the immune system, patients' white blood cells (lymphocytes) will be obtained, involving a separate informed consent. The procedure, called leukaphersis, requires inserting a needle into the arm, to obtain blood going into a machine, which divides the blood into red cells, plasma (or the serum part), and lymphocytes. The lymphocytes are removed, and the plasma and red cells returned to the patient through a second needle in the other arm. Risks associated with the procedure include fainting, which can be prevented by patients' eating before coming to the lab, and bleeding and infection at the needle site. Patients will undergo leukapheresis will be done about four times: before receiving the vaccine, 3 weeks after the first four doses, and then after 8 cycles and 12 cycles. Patients assigned to the groups receiving imiquimod will be asked to record every time they apply that cream and describe any symptoms developed during the study. All patients will be watched closely for any sign that their melanoma has returned. Before and throughout the study, multiple blood tests will be conducted.
The vaccine, Montanide, and imiquimod may increase patients' immune system in fighting off new tumors, but that is not known now. However, the study may provide information that will be useful in treating melanoma patients in the future.
Detailed description
Background:
A previous clinical trial has been conducted in the Surgery Branch National Cancer Institute (NCI) in which gp100 immunizations have been administered to patients with melanoma in the adjuvant setting. In this prior protocol, the peptide emulsified in Incomplete Freund's Adjuvant was administered subcutaneously using several different schedules and was well tolerated except for mild and transient erythema at the site of injection. Each of the schedules provided successful immunization although the q3w schedule was the best tolerated locally and three courses of immunization appeared to be sufficient using this regimen. An important finding from the adjuvant protocol however was the significant increase in immune precursors specifically reactive against peptide and tumor that occurred with increasing courses of immunization. These findings have encouraged us to now further explore the optimal methods for generating immune precursors using the gp100:209-217(210M) peptide by testing the impact of an additional immune adjuvant, imiquimod, reported to increase the immunizing potential of antigens as well as evaluate an alternate route of injection, intradermal administration.
Objectives:
The primary objective of this trial is to evaluate the immunologic activity of immunization with four different preparations of the gp100:209-217(210M) melanoma antigen peptide and potentially select one for further study.
Eligibility:
HLA-A 0201 patients, age greater than or equal 16 years, with primary melanomas with lesions that are ulcerated and greater than or equal 2mm, or any lesions that are greater than or equal 4.0 mm in thickness, or greater than or equal 1 positive lymph node, or local recurrence, or resected metastatic disease, within 6 months of surgical resection will be considered. Patients who have ocular or mucosal melanoma or who require systemic steroid therapy will be excluded. The following patients will also be excluded: have previously been immunized with gp100; have known hypersensitivity to any of the agents used in this study; have previously received chemotherapy for treatment of melanoma; or who are undergoing or have undergone in the past 3 weeks any systemic therapy except surgery for their cancer.
Design:
Patients will be randomized into one of the following four arms:
- gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
- gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
- gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
- gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
Immunizations will be administered on an outpatient basis unless side effects or the patient's clinical condition warrants hospitalization. Patients will receive full clinical evaluation three weeks after 8 cycles and 12 cycles.
Each of the arms will be conducted using a two-stage optimal design Since the primary objective is to select one regimen from among the four on the basis of the immune response, this design allows there to be greater than 80% probability of correctly selecting the superior arm if there is either a tie in the number of immune responses, or if there is at least one more immune response on one arm than the other three arms, and if the true response rates are 15%, 15%, 15% and 35%. Initially, 19 patients will be enrolled in each arm and evaluated; if 0 to 3 of 19 in an arm have an immune response to T2 cells pulsed with 0.01 M peptide after the 4th, 8th, and 12th cycles, no further patients would be randomized to receive the peptide on that arm. If at least four immunologic responses are noted after the 8th cycle, then accrual to 33 patients would take place. If all four arms need to be completed and 33 patients need to be completed in each arm, a total of 132 patients are required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Adj-3 A2 gp209(2M) in IFA SQ (vortex) | Experimental | Drug: gp100:209-217 (210M), Drug: Montanide ISA-51gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks). |
| Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (vortex) | Experimental | Drug: gp100:209-217 (210M), Drug: Montanide ISA-51, Drug: Imiquimodgp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days. |
| Adj-3 A2 gp209(2M) in saline ID | Experimental | Drug: gp100:209-217 (210M)gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks). |
| Adj-3 A2 gp209(2M) in saline ID + Imiquimod | Experimental | Drug: gp100:209-217 (210M), Drug: Imiquimodgp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days. |
| Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe) | Experimental | Drug: gp100:209-217 (210M), Drug: Montanide ISA-51gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks). |
| Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe) | Experimental | Drug: gp100:209-217 (210M), Drug: Montanide ISA-51, Drug: Imiquimodgp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- HLA-A 0201 patients, age greater than or equal to 16 years, primary melanomas with lesions that are ulcerated and greater than or equal to 2mm, or any lesions that are greater than or equal to 4.0 mm in thickness, or greater than or equal to1 positive lymph node, or local recurrence, or resected metastatic disease, within 6 months of surgical resection will be considered. Patients must be clinically disease free at the time of protocol entry as documented by radiologic studies within 6 weeks of patient entry.
- Serum creatinine of 2.0 mg/dl or less
- Total bilirubin 1.6 mg/dl or less, except for patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.
- WBC 3000/mm^3 or greater,
- Platelet count 90,000 mm^3 or greater,
Key exclusion criteria (11 listed)
- Who have ocular or mucosal melanoma.
- Who are undergoing or have undergone in the past 3 weeks any systemic therapy except surgery for their cancer, and must have recovered to a grade I from any adverse effects of treatment prior to entry, other than those that do not have clinical implications, e.g. vitiligo, alopecia.
- Have active systemic infections, autoimmune disease or any known immunodeficiency disease.
- Who require systemic steroid therapy.
- Who are pregnant (because of possible side effects on the fetus) or breastfeeding because of unknown effects on the developing child).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gp100:209-217 (210M) | Drug | Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe), Adj-3 A2 gp209(2M) in IFA SQ (vortex), Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe), Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (vortex), Adj-3 A2 gp209(2M) in saline ID, Adj-3 A2 gp209(2M) in saline ID + Imiquimod |
| Montanide ISA-51 | Drug | Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe), Adj-3 A2 gp209(2M) in IFA SQ (vortex), Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe), Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (vortex) |
| ImiquimodAlso: AldaraApply imiquimod 5% cream to the skin at the site of injection daily for 5 days | Drug | Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe), Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (vortex), Adj-3 A2 gp209(2M) in saline ID + Imiquimod |
Primary outcome
Immunologic Response Rate
Time frame: 48 months
Comparison of six different preparations of the gp100:209-217 (210M) melanoma antigen peptide. The arm with the greater number of immunologic responses will be the one most likely to be selected for future study on the basis of immunization alone. Evidence of immunization consist of at least 10 Elispots/100,000 cells above background. An injection site reaction is not an immune response.
1 secondary outcome
Number of Participants With Adverse Events
Time frame: 48 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8170938Kawakami Y, Eliyahu S, Delgado CH, Robbins PF, Rivoltini L, Topalian SL, Miki T, Rosenberg SA. Cloning of the gene coding for a shared human melanoma antigen recognized by autologous T cells infiltrating into tumor. Proc Natl Acad Sci U S A. 1994 Apr 26;91(9):3515-9. doi: 10.1073/pnas.91.9.3515.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven A Rosenberg, M.D. principal investigator
National Cancer Institute, National Institutes of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gp100:209-217 (210M), Montanide ISA-51 and Imiquimod in people with High-Risk Melanoma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunologic Response Rate (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00273910, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2012.