MelanomaPhase 1NCT00698100
Vaccination of AJCC Stage IIB, IIC, III and IV Melanoma Patients With Human and Mouse Tyrosinase DNA Vaccines
A Phase 1 study testing human tyrosinase and mouse tyrosinase in people with Melanoma and Skin, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The overall goal of this study is to find out about the safety of injecting the genes (DNA) for human and mouse tyrosinase in patients with melanoma. There is no evidence yet that injection of tyrosinase DNA results in any clinical benefit. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- human tyrosinase and mouse tyrosinase
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Sep 2011
- 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
Who may be able to join
- Patients must have documented malignant melanoma, American Joint Commission on Cancer (AJCC) stage IIB, IIC, III or IV. Patients free of disease after surgical resection will also be eligible.
- For all patients, pathology slides must be reviewed by the Memorial Hospital Department of Pathology for confirmation of melanoma diagnosis.
- Patients must be HLA-A0201 positive.
- Patients must be at least 18 years of age to be eligible and must be able to read the informed consent and give informed consent.
- Patients must have a Karnofsky performance status of at least 80.
- LDH < than or = to 2x upper limit of normal value; albumin > than or = to 3.5 mg/dl.
- A CBC prior to vaccination with WBC > or = to 3000, platelets > or = to 100,000.
- Patients must be free of detectable brain metastases.
Who cannot join
- Patients may not be receiving or have received chemotherapy, immunotherapy or radiation therapy within the previous 4 weeks. Patients must be fully recovered from any previous therapy or surgery.
- Patients may not have been previously immunized with vaccines containing tyrosinase or peptides derived from tyrosinase.
- Any medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to respond immunologically to vaccines is grounds for exclusion, at the discretion of the Principal Investigator or co-Principal Investigators.
- Patients who have preexisting retinal or choroidal eye disease will be excluded.
- Patients with serious underlying medical conditions, active infections requiring antimicrobial drugs, or active bleeding will be ineligible.
- Pregnant women or women who are less than 3 months post-partum are not eligible. Women who may yet bear children and sexually active men must be using appropriate contraception during the course of this study. Women of child-bearing potential must not be pregnant (negative BHCG within 2 weeks of vaccination) nor be nursing during treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Vaccination of AJCC Stage IIB, IIC, III and IV Melanoma Patients With Human and Mouse Tyrosinase DNA Vaccines: A Phase I Trial to Assess Safety and Immune Response
The overall goal of this study is to find out about the safety of injecting the genes (DNA) for human and mouse tyrosinase in patients with melanoma. There is no evidence yet that injection of tyrosinase DNA results in any clinical benefit. Tyrosinase is the substance found in melanoma cells that helps to produce their black color. The DNA used in this study was purified from bacteria which contains the gene for tyrosinase. DNA is material which contains the information needed to produce many substances in the body.
- Being tested
- human tyrosinase, mouse tyrosinase
- Keywords
- DNA, HU & MOUSE, TYROSINASE
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human tyrosinaseBiological
Patients will receive a total of 6 vaccinations. Each vaccination is given via the intramuscular route. Sites of injection should have intact lymphatic drainage. The vaccinations will be administered at three week intervals. Groups of six patients will be randomized at each dose level to receive either three immunizations with mouse tyrosinase followed by three immunizations with human tyrosinase or three immunizations with human tyrosinase followed by three immunizations with mouse tyrosinase
mouse tyrosinaseBiological
Patients will receive a total of 6 vaccinations. Each vaccination is given via the intramuscular route. Sites of injection should have intact lymphatic drainage. The vaccinations will be administered at three week intervals. Groups of six patients will be randomized at each dose level to receive either three immunizations with mouse tyrosinase followed by three immunizations with human tyrosinase or three immunizations with human tyrosinase followed by three immunizations with mouse tyrosinase
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients will get human tyrosinase vaccination. Receives: Biological: human tyrosinase |
| 2 | Experimental | Patient will get mouse tyrosinase DNA vaccination. Receives: Biological: mouse tyrosinase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is to determine the safety and immunogenicity of vaccination with the genes coding for mouse and human tyrosinase in patients.
Measured: conclusion of the study
Secondary outcomes (2)
To evaluate antibody and CD8+ T cell responses to human tyrosinase after vaccination.
Measured: conclusion of the study
Is to observe the patients for evidence of any anti-tumor response, which is generated after vaccination.
Measured: conclusion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2008 (estimated)
- Study startJun 2002
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Jedd Wolchok, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698100
- Sponsor's protocol ID
- 99-122
- Status last verified
- Sep 2011
- First submitted
- 12 Jun 2008
- Last updated
- 16 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination of AJCC Stage IIB, IIC, III and IV Melanoma Patients With Human and Mouse Tyrosinase DNA Vaccines: A Phase I Trial to Assess Safety and Immune Response
- ClinicalTrials.gov ID
- NCT00698100
- Acronym / sponsor ID
- 99-122
- Keywords
- DNA, HU & MOUSE, TYROSINASE
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jun 2002
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 16 Jun 2008 (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.
The overall goal of this study is to find out about the safety of injecting the genes (DNA) for human and mouse tyrosinase in patients with melanoma. There is no evidence yet that injection of tyrosinase DNA results in any clinical benefit. Tyrosinase is the substance found in melanoma cells that helps to produce their black color. The DNA used in this study was purified from bacteria which contains the gene for tyrosinase. DNA is material which contains the information needed to produce many substances in the body.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: human tyrosinasePatients will get human tyrosinase vaccination. |
| 2 | Experimental | Biological: mouse tyrosinasePatient will get mouse tyrosinase DNA vaccination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must have documented malignant melanoma, American Joint Commission on Cancer (AJCC) stage IIB, IIC, III or IV. Patients free of disease after surgical resection will also be eligible.
- For all patients, pathology slides must be reviewed by the Memorial Hospital Department of Pathology for confirmation of melanoma diagnosis.
- Patients must be HLA-A0201 positive.
- Patients must be at least 18 years of age to be eligible and must be able to read the informed consent and give informed consent.
- Patients must have a Karnofsky performance status of at least 80.
Key exclusion criteria (6 listed)
- Patients may not be receiving or have received chemotherapy, immunotherapy or radiation therapy within the previous 4 weeks. Patients must be fully recovered from any previous therapy or surgery.
- Patients may not have been previously immunized with vaccines containing tyrosinase or peptides derived from tyrosinase.
- Any medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to respond immunologically to vaccines is grounds for exclusion, at the discretion of the Principal Investigator or co-Principal Investigators.
- Patients who have preexisting retinal or choroidal eye disease will be excluded.
- Patients with serious underlying medical conditions, active infections requiring antimicrobial drugs, or active bleeding will be ineligible.
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 |
|---|---|---|
| human tyrosinasePatients will receive a total of 6 vaccinations. Each vaccination is given via the intramuscular route. Sites of injection should have intact lymphatic drainage. The vaccinations will be administered at three week intervals. Groups of six patients will be randomized at each dose level to receive either three immunizations with mouse tyrosinase followed by three immunizations with human tyrosinase or three immunizations with human tyrosinase followed by three immunizations with mouse tyrosinase | Biological | 1 |
| mouse tyrosinasePatients will receive a total of 6 vaccinations. Each vaccination is given via the intramuscular route. Sites of injection should have intact lymphatic drainage. The vaccinations will be administered at three week intervals. Groups of six patients will be randomized at each dose level to receive either three immunizations with mouse tyrosinase followed by three immunizations with human tyrosinase or three immunizations with human tyrosinase followed by three immunizations with mouse tyrosinase | Biological | 2 |
Primary outcome
Is to determine the safety and immunogenicity of vaccination with the genes coding for mouse and human tyrosinase in patients.
Time frame: conclusion of the study
2 secondary outcomes
To evaluate antibody and CD8+ T cell responses to human tyrosinase after vaccination.
Time frame: conclusion of the study
Is to observe the patients for evidence of any anti-tumor response, which is generated after vaccination.
Time frame: conclusion of the study
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 16 Sep 2011.
- Memorial Sloan-Kettering Cancer CenterLink 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.
Jedd Wolchok, MD principal investigator
Memorial Sloan Kettering Cancer Center
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 human tyrosinase and mouse tyrosinase in people with Melanoma and Skin, run by Memorial Sloan Kettering Cancer Center 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 8 inclusion and 6 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 16 Sep 2011. 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.
What does the primary outcome measure?
Is to determine the safety and immunogenicity of vaccination with the genes coding for mouse and human tyrosinase in patients. (time frame: conclusion of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2011.