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
- Patients who have completed protocol 10M-01-1 or 10M-00-4 are eligible for this study
1. They have received all injections with evidence of an immune response.
2. They have not experienced recurrence of the melanoma.
3. Not more than twelve months have elapsed since the final injection on either
4. They experienced no grade 3 or 4 toxicity attributed to the prior vaccine
- 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.
- 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.
- 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.