Vaccine Therapy With or Without Sargramostim in Treating Patients Who Have Undergone Surgery for … (NCT00089063) | Clinical Trial Compass
CompletedPhase 2
Vaccine Therapy With or Without Sargramostim in Treating Patients Who Have Undergone Surgery for Melanoma
United States40 participantsStarted 2004-06
Plain-language summary
This randomized phase II trial is studying vaccine therapy and sargramostim to see how well they work compared to vaccine therapy alone in treating patients who have undergone surgery for stage IIB, stage IIC, stage III, or stage IV melanoma. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may make a stronger immune response.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* SGOT/SGPT of 2.5 X institutional norm or less
* Total WBC of 3,000 or more
* At least 1500 granulocytes
* Hemoglobin of 9.0 gm/dl or more
* 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 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:
* Who have undergone any other systemic therapy for their melano…