Melanoma (Skin)Phase 1NCT00091338
Interleukin-7 and Vaccine Therapy in Treating Patients With Metastatic Melanoma
A Phase 1 study testing MART-1 antigen, gp100 antigen and incomplete Freund's adjuvant in people with Melanoma (Skin), run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
RATIONALE: Interleukin-7 may stimulate a person's white blood cells to kill tumor cells. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Combining interleukin-7 with vaccine therapy may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- MART-1 antigen, gp100 antigen and incomplete Freund's adjuvant
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed melanoma
- Metastatic disease
- Measurable or evaluable disease
- Disease progression during or after prior interleukin-2 (IL-2) OR ineligible to receive high-dose IL-2* OR has disease burden for which IL-2 is not indicated* NOTE: *If patient did not receive prior IL-2, must have progressed after prior standard first-line therapy (e.g., metastasectomy for single lesions or dacarbazine)
- HLA-A*0201-positive disease
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 3 months
Hematopoietic
- Absolute neutrophil count > 1,000/mm^3*
- Absolute lymphocyte count ≥ 200/mm^3*
- Platelet count > 100,000/mm^3
- No proliferative hematologic disease NOTE: *For 2 consecutive readings performed on 2 different days
Hepatic
- AST and ALT < 3 times upper limit of normal (ULN)
- PT/PTT ≤ 1.5 times ULN
- Hepatitis B negative
- Positive hepatitis B serology indicative of prior immunization (i.e., positive for antibody against hepatitis B surface antigen AND negative for antibody against hepatitis B core antigen) allowed
- Hepatitis C negative
Renal
- Creatinine ≤ 1.4 mg/dL
Cardiovascular
- Ejection fraction > 45% by MUGA for patients ≥ 50 years of age OR with a history of cardiac disease
- No resting blood pressure > 140/90 mm Hg with standard antihypertensive therapy
Pulmonary
- DLCO/VA and FEV_1 > 50% of predicted on pulmonary function test for smokers OR for patients with clinical evidence of compromised pulmonary function
- No history of severe asthma
Immunologic
- HIV negative
- No history of autoimmune disease
- No splenomegaly
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other medical or psychiatric disease that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- More than 4 weeks since prior cytokines
- No prior allogeneic hematopoietic stem cell transplantation
- No concurrent growth factors
- No concurrent monoclonal antibodies
- No other concurrent immunotherapy
- No other concurrent cytokines
- No other concurrent biologic agents
Chemotherapy
- See Disease Characteristics
- No prior intensive myeloablative chemotherapy
- No concurrent chemotherapy
Endocrine therapy
- More than 2 weeks since prior systemic corticosteroids for more than 72 hours in duration
- No concurrent systemic steroids
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
- No prior splenectomy
- No prior solid organ transplantation
Other
- More than 4 weeks since prior cytotoxic therapy
- No other concurrent cytotoxic therapy
- No concurrent chronic anticoagulation therapy (e.g., high-dose warfarin, heparin, or aspirin)
- Concurrent low-dose warfarin (1-2 mg) allowed
- No concurrent chronic medication for asthma
- No concurrent immunosuppressive therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
About this study
Official title: A Study of Subcutaneous "CYT 99 007" (Interleukin-7) in Conjunction With Peptide Immunization in Patients With Metastatic Melanoma
RATIONALE: Interleukin-7 may stimulate a person's white blood cells to kill tumor cells. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Combining interleukin-7 with vaccine therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-7 when given with vaccine therapy in treating patients with metastatic melanoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of interleukin-7 (IL-7) when administered with melanoma peptide vaccine emulsified in Montanide ISA-51 in patients with metastatic melanoma.
- Determine the safety of this regimen in these patients.
Secondary
- Determine the biological effects of this regimen on T-cell function and phenotype at various doses and at the optimal biological dose in these patients.
- Determine the pharmacokinetic and pharmacodynamic characteristics of IL-7 in patients treated with this regimen.
- Determine the antitumor effects of IL-7, in terms of a dose-escalation strategy, in these patients.
OUTLINE: This is a dose-escalation study of interleukin-7 (IL-7).
Patients receive IL-7 subcutaneously (SC) on days 0, 3, 6, 9, 12, 15, 18, and 21. Patients also receive melanoma peptide vaccine comprising gp100 antigen and MART-1 antigen emulsified in Montanide ISA-51 SC on days 0, 7, 14, and 21 in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of IL-7 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After the MTD is determined, an additional 13 patients are treated at that dose level.
Patients are followed at 1, 2, and 5 weeks, at 3 and 6 months, and then at 1 year.
PROJECTED ACCRUAL: A total of 3-37 patients will be accrued for this study within 1-12.3 months.
- Conditions
- Melanoma (Skin)
- Being tested
- MART-1 antigen, gp100 antigen, incomplete Freund's adjuvant, recombinant interleukin-7
- Keywords
- recurrent melanoma, stage IV melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MART-1 antigenBiological
gp100 antigenBiological
incomplete Freund's adjuvantBiological
recombinant interleukin-7Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2004 (estimated)
- Study startAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Melanoma (Skin)Studies 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 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Steven A. Rosenberg, MD, PhD, Principal investigator, NCI - Surgery Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00091338
- Sponsor's protocol ID
- CDR0000387802
- Other IDs
- NCI-04-C-0235
- Status last verified
- Jan 2005
- First submitted
- 7 Sep 2004
- Last updated
- 30 Apr 2015
- Results posted
- No
Publications
Rosenberg SA, Sportes C, Ahmadzadeh M, Fry TJ, Ngo LT, Schwarz SL, Stetler-Stevenson M, Morton KE, Mavroukakis SA, Morre M, Buffet R, Mackall CL, Gress RE. IL-7 administration to humans leads to expansion of CD8+ and CD4+ cells but a relative decrease of CD4+ T-regulatory cells. J Immunother. 2006 May-Jun;29(3):313-9. doi: 10.1097/01.cji.0000210386.55951.c2.
PubMed 16699374
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Subcutaneous "CYT 99 007" (Interleukin-7) in Conjunction With Peptide Immunization in Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00091338
- Acronym / sponsor ID
- CDR0000387802
- Conditions
- Melanoma (Skin)
- Keywords
- recurrent melanoma, stage IV melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Aug 2004
- First posted
- 9 Sep 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Interleukin-7 may stimulate a person's white blood cells to kill tumor cells. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Combining interleukin-7 with vaccine therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-7 when given with vaccine therapy in treating patients with metastatic melanoma.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of interleukin-7 (IL-7) when administered with melanoma peptide vaccine emulsified in Montanide ISA-51 in patients with metastatic melanoma.
- Determine the safety of this regimen in these patients.
Secondary
- Determine the biological effects of this regimen on T-cell function and phenotype at various doses and at the optimal biological dose in these patients.
- Determine the pharmacokinetic and pharmacodynamic characteristics of IL-7 in patients treated with this regimen.
- Determine the antitumor effects of IL-7, in terms of a dose-escalation strategy, in these patients.
OUTLINE: This is a dose-escalation study of interleukin-7 (IL-7).
Patients receive IL-7 subcutaneously (SC) on days 0, 3, 6, 9, 12, 15, 18, and 21. Patients also receive melanoma peptide vaccine comprising gp100 antigen and MART-1 antigen emulsified in Montanide ISA-51 SC on days 0, 7, 14, and 21 in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of IL-7 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After the MTD is determined, an additional 13 patients are treated at that dose level.
Patients are followed at 1, 2, and 5 weeks, at 3 and 6 months, and then at 1 year.
PROJECTED ACCRUAL: A total of 3-37 patients will be accrued for this study within 1-12.3 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| MART-1 antigen | Biological | – |
| gp100 antigen | Biological | – |
| incomplete Freund's adjuvant | Biological | – |
| recombinant interleukin-7 | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
- Results publication: PubMed 16699374Rosenberg SA, Sportes C, Ahmadzadeh M, Fry TJ, Ngo LT, Schwarz SL, Stetler-Stevenson M, Morton KE, Mavroukakis SA, Morre M, Buffet R, Mackall CL, Gress RE. IL-7 administration to humans leads to expansion of CD8+ and CD4+ cells but a relative decrease of CD4+ T-regulatory cells. J Immunother. 2006 May-Jun;29(3):313-9. doi: 10.1097/01.cji.0000210386.55951.c2.
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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, MD, PhD principal investigator
NCI - Surgery Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MART-1 antigen, gp100 antigen and incomplete Freund's adjuvant in people with Melanoma (Skin), 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?
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 30 Apr 2015. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00091338, 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 30 Apr 2015.