Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT00184067
Eligibility Criteria:
Inclusion Criteria:
* 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.
* 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.
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00184067
Study Brief:
Protocol Section:
NCT00184067