Monoclonal Antibody Therapy and Vaccine Therapy in Treating Patients With Resected Stage III or S… (NCT00084656) | Clinical Trial Compass
CompletedPhase 2
Monoclonal Antibody Therapy and Vaccine Therapy in Treating Patients With Resected Stage III or Stage IV Melanoma
United States77 participantsStarted 2004-05-31
Plain-language summary
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines may make the body build an immune response to kill tumor cells. Combining the vaccines with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells. Giving monoclonal antibody therapy together with vaccine therapy may be an effective treatment for stage III or stage IV melanoma.
PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together with vaccine therapy works in treating patients with resected stage III or stage IV melanoma.
Who can participate
Age range
18 Years – 120 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.
DISEASE CHARACTERISTICS:
* Histologically confirmed melanoma
* Stage III (≥ 3 positive lymph nodes) or stage IV disease
* Mucosal or ocular melanoma allowed
* Completely resected within the past 6 months
* Patients with stage III resected melanoma rendered free of disease may have failed, been ineligible for, or refused prior treatment with interferon alfa
* Positive staining of tumor tissue for at least one of the following:
* Antibody HMB-45 for gp100
* Antibody HMB-45 for tyrosinase
* Antibody HMB-45 for MART-1
* HLA-A\*0201 positive by DNA allele-specific polymerase chain reaction assay
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* At least 6 months
Hematopoietic
* WBC ≥ 2,500/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hematocrit ≥ 30%
* Hemoglobin ≥ 10 g/dL
Hepatic
* AST ≤ 3 times upper limit of normal (ULN)\*
* Bilirubin ≤ ULN\* (\< 3.0 mg/dL for patients with Gilbert's syndrome)
* No significant hepatic disease that would preclude study participation
* Hepatitis B surface antigen negative
* Hepatitis C antibody negative NOTE: \* Unless attributable to disease
Renal
* Creatinine ≤ 2.0 mg/dL
* No significant renal disease that would preclude study participation
Cardiovascular
* No significant cardiac disease that would preclude study participation
Pulmonary
* No significant pulmonary disease that would preclude study participation
Immunologic
* No history …
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.
What they're measuring
1
Percentage of Participants With Immune-related Adverse Events (irAEs)
Timeframe: Between first dose and 70 days after last dose of study therapy (up to 3 years including maintenance phase)