Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Southern California
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients who have completed protocol 10M-01-1 or 10M-00-4 are eligible for this study provided that:
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 protocol.
4. 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.
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.
You may not be if
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.
