MelanomaPhase 2NCT00184067
Continuation Booster Trial After a Vaccine Combining Tyrosinase/GP100/MART-1 Peptides Emulsified With Montanide ISA 51 With or Without GM-CSF for Patients With Melanoma
A Phase 2 study testing Montanide ISA 51 in people with Melanoma, run by University of Southern California at 1 site in United States.
Trial summary
This is a study of a melanoma vaccine. Study participants will have melanoma that invaded deeply and spread to lymph nodes or another location. Although the participants' melanoma has been removed, there is a greater than 1 out of 2 chance it will return. There will be approximately 40 subjects in this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Montanide ISA 51
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Sep 2009
- Phase
- Phase 2
- 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 who have completed protocol 10M-01-1 or 10M-00-4 are eligible for this study provided that:
- They have received all injections with evidence of an immune response.
- They have not experienced recurrence of the melanoma.
- Not more than twelve months have elapsed since the final injection on either protocol.
- They experienced no grade 3 or 4 toxicity attributed to the prior vaccine regimen.
- Serum creatinine of 2.0 mg/dl or less, total bilirubin of 2.0 mg/dl or less and SGOT/SGPT of 2.5 X institutional norm or less.
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- Total whte blood cell (WBC) of 3,000 or more with at least 1500 granulocytes, hemoglobin of 9.0 gm/dl or more, and platelet count of 100,000 per cu mm or more.
- ECOG performance status of 0 or 1.
- Patients will be eligible for this trial if they have failed alpha-interferon, if it is felt to be contraindicated due to a pre-existing medical or psychiatric condition or if they have refused treatment with it.
- Ability to read, understand and willingness to sign an institutional review board (IRB)-approved informed consent.
- Patients who have had another malignancy but with no evidence of disease for greater than 5 years from accrual to the current trial will be eligible if it is felt they are likely to be cured. Patients with squamous or basal carcinoma of the skin or carcinoma in situ of the cervix that have been treated with curative intent can be accrued to this trial 30 days after treatment.
Who cannot join
- Patients who have undergone any other systemic therapy for their melanoma, including radiation therapy since completion of 10M-01-1 or 10M-00-4.
- Have major systemic infections like pneumonia or sepsis, coagulation or bleeding disorders, or other major medical illnesses of the gastrointestinal, cardiovascular or respiratory systems.
- Require systemic, ocular or inhaled corticosteroids.
- Pregnant or lactating, since the risk of autoimmune reactivity to tyrosinase, MART-1 or gp100 is felt to present a risk to the fetus or a breast feeding infant. Effective birth control for men and women is required during and for four months after the study is finished.
- Known to be positive for hepatitis BsAg, hepatitis C antibody or HIV antibody. Since cells removed for ex vivo handling and tissue culture cannot be virus positive, and the effects of melanoma peptides might be detrimental to HIV positive patients, patients positive for the above viruses will not be treated in this trial.
- Have had a known allergic reaction to GM-CSF, Montanide ISA 51 (IFA) or any of the peptides included in this protocol.
- Have a prior history of uveitis or autoimmune inflammatory eye disease, immune hemolytic anemia or other active autoimmune disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: A Randomized Phase II Continuation Booster Trial After a Vaccine Combining Tyrosinase/GP100/MART-1 Peptides Emulsified With Montanide ISA 51 With or Without GM-CSF for Patients With Resected Stages IIB/C, III, and IV Melanoma
This is a study of a melanoma vaccine. Study participants will have melanoma that invaded deeply and spread to lymph nodes or another location. Although the participants' melanoma has been removed, there is a greater than 1 out of 2 chance it will return. There will be approximately 40 subjects in this study. The patients will have already taken part in a melanoma vaccine study, and in this current study, they will continue to receive booster injections of a similar vaccine given for two additional years.
This study will test an experimental vaccine. The vaccine contains peptides which are fragments of substances made by most melanomas. The substances are tyrosinase, gpl00 and melanoma antigen recognized by T cells (MART-1). The vaccine also includes an assistant called Montanide ISA 51. The assistant stimulates the immune system. This study will also test the effects of a second assistant granulocyte-macrophage colony-stimulating factor (GM-CSF). All participants will receive the vaccine and assistant Montanide ISA 51, but only half will receive the assistant GM-CSF. The patients have a one in two chance of receiving the assistant called GM-CSF. The main purpose of this study is to find out if the booster injections increase the body's immunity to melanoma and prevent its level of immunity from getting lower over time. The investigators also wish to know if the GM-CSF increases the body's immunity to melanoma when given with the melanoma vaccine.
The vaccine and assistant Montanide ISA 51 are not approved by the Food and Drug Administration (FDA). The assistant GM-CSF is approved by the FDA to increase infection-fighting white blood cells after chemotherapy. It is not approved by the FDA for treatment of melanoma. However, the FDA is permitting the vaccine and the assistants to be tested in this study.
- Conditions
- Melanoma
- Being tested
- Montanide ISA 51
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montanide ISA 51Biological
| Study group | Role | What they receive |
|---|---|---|
| Peptide vaccine with Montanide ISA 51 + GM-CSF | Experimental | Peptide vaccine with Montanide ISA 51 GM-CSF Receives: Biological: Montanide ISA 51 |
| Peptide vaccine with Montanide ISA 51 | Active comparator | Peptide vaccine with Montanide ISA 51 Receives: Biological: Montanide ISA 51 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionApr 2007
- Study completionSep 2009
Why it stopped: Primary PI left institution
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 University of Southern CaliforniaThe 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Weber, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184067
- Sponsor's protocol ID
- 10M-03-8
- Status last verified
- Jan 2014
- First submitted
- 12 Sep 2005
- Last updated
- 21 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Continuation Booster Trial After a Vaccine Combining Tyrosinase/GP100/MART-1 Peptides Emulsified With Montanide ISA 51 With or Without GM-CSF for Patients With Resected Stages IIB/C, III, and IV Melanoma
- ClinicalTrials.gov ID
- NCT00184067
- Acronym / sponsor ID
- 10M-03-8
- Conditions
- Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primary PI left institution
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 16 Sep 2005 (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.
This is a study of a melanoma vaccine. Study participants will have melanoma that invaded deeply and spread to lymph nodes or another location. Although the participants' melanoma has been removed, there is a greater than 1 out of 2 chance it will return. There will be approximately 40 subjects in this study. The patients will have already taken part in a melanoma vaccine study, and in this current study, they will continue to receive booster injections of a similar vaccine given for two additional years.
This study will test an experimental vaccine. The vaccine contains peptides which are fragments of substances made by most melanomas. The substances are tyrosinase, gpl00 and melanoma antigen recognized by T cells (MART-1). The vaccine also includes an assistant called Montanide ISA 51. The assistant stimulates the immune system. This study will also test the effects of a second assistant granulocyte-macrophage colony-stimulating factor (GM-CSF). All participants will receive the vaccine and assistant Montanide ISA 51, but only half will receive the assistant GM-CSF. The patients have a one in two chance of receiving the assistant called GM-CSF. The main purpose of this study is to find out if the booster injections increase the body's immunity to melanoma and prevent its level of immunity from getting lower over time. The investigators also wish to know if the GM-CSF increases the body's immunity to melanoma when given with the melanoma vaccine.
The vaccine and assistant Montanide ISA 51 are not approved by the Food and Drug Administration (FDA). The assistant GM-CSF is approved by the FDA to increase infection-fighting white blood cells after chemotherapy. It is not approved by the FDA for treatment of melanoma. However, the FDA is permitting the vaccine and the assistants to be tested in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peptide vaccine with Montanide ISA 51 + GM-CSF | Experimental | Biological: Montanide ISA 51Peptide vaccine with Montanide ISA 51 GM-CSF |
| Peptide vaccine with Montanide ISA 51 | Active comparator | Biological: Montanide ISA 51Peptide vaccine with Montanide ISA 51 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients who have completed protocol 10M-01-1 or 10M-00-4 are eligible for this study provided that:
- Serum creatinine of 2.0 mg/dl or less, total bilirubin of 2.0 mg/dl or less and SGOT/SGPT of 2.5 X institutional norm or less.
- Total whte blood cell (WBC) of 3,000 or more with at least 1500 granulocytes, hemoglobin of 9.0 gm/dl or more, and platelet count of 100,000 per cu mm or more.
- ECOG performance status of 0 or 1.
- Patients will be eligible for this trial if they have failed alpha-interferon, if it is felt to be contraindicated due to a pre-existing medical or psychiatric condition or if they have refused treatment with it.
Key exclusion criteria (7 listed)
- Patients who have undergone any other systemic therapy for their melanoma, including radiation therapy since completion of 10M-01-1 or 10M-00-4.
- Have major systemic infections like pneumonia or sepsis, coagulation or bleeding disorders, or other major medical illnesses of the gastrointestinal, cardiovascular or respiratory systems.
- Require systemic, ocular or inhaled corticosteroids.
- Pregnant or lactating, since the risk of autoimmune reactivity to tyrosinase, MART-1 or gp100 is felt to present a risk to the fetus or a breast feeding infant. Effective birth control for men and women is required during and for four months after the study is finished.
- Known to be positive for hepatitis BsAg, hepatitis C antibody or HIV antibody. Since cells removed for ex vivo handling and tissue culture cannot be virus positive, and the effects of melanoma peptides might be detrimental to HIV positive patients, patients positive for the above viruses will not be treated in this trial.
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 |
|---|---|---|
| Montanide ISA 51 | Biological | Peptide vaccine with Montanide ISA 51, Peptide vaccine with Montanide ISA 51 + GM-CSF |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Primary PI left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2014.
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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.
Jeffrey Weber principal investigator
University of Southern California
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 Montanide ISA 51 in people with Melanoma, run by University of Southern California 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 11 inclusion and 7 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: stopped early, as of the sponsor's last update on 21 May 2014. 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?
The study was stopped early (reason given: Primary PI left institution). Results are not available in the source record.
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?
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 21 May 2014.