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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.