Clinical trial · Interventional
Vaccine Therapy and Sargramostim in Treating Patients With Stage IV Malignant Melanoma
Melanoma Vaccines: Differentiation Antigen Peptides (MART-1:27-35, Tyrosinase and Gp-100) as Immune Targets
NCT00006243CI-TRIAL-00009155completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized pilot clinical trial studies vaccine therapy and sargramostim in treating patients with stage IV malignant melanoma. Vaccines made from melanoma peptides or antigens may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as sargramostim, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy together with sargramostim may be an effective treatment for malignant melanoma
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gp100 antigen | Biological | — | UNRESOLVED |
| incomplete Freund's adjuvant | Biological | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| MART-1:27-35 peptide vaccine | Biological | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
| tyrosinase peptide | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I (vaccine therapy)
- description
- Patients receive tyrosinase peptide, MART-1:27-35 peptide vaccine, and gp100 antigen admixed in incomplete Freund's adjuvant SC on day 1 of weeks 0, 3, 6, 9, 12, and 24.
- interventionNames
- Biological: tyrosinase peptide
- Biological: MART-1:27-35 peptide vaccine
- Biological: gp100 antigen
- Biological: incomplete Freund's adjuvant
- Other: laboratory biomarker analysis
- type
- EXPERIMENTAL
- label
- Arm II (vaccine therapy and lower-dose sargramostim)
- description
- Patients receive tyrosinase peptide, MART-1:27-35 peptide vaccine, and gp100 antigen admixed in incomplete Freund's adjuvant SC and lower-dose sargramostim SC on day 1 of weeks 0, 3, 6, 9, 12, and 24.
- interventionNames
- Biological: tyrosinase peptide
- Biological: MART-1:27-35 peptide vaccine
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Human leukocyte antigen (HLA)-A2 positive * Histologic proof of stage IV malignant melanoma with measurable disease * Absolute neutrophil count (ANC) \>= 1500 * Platelets (PLT) \>= 100,000 * Alkaline phosphatase (Alk phos) =\< 3 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) =\< 3 x ULN * Creatinine (Creat) =\< 1.5 x ULN * Hemoglobin (Hgb) \> 9.0 * Ability to provide informed consent * Willingness to return to a Mayo Clinic institution for follow-up * Life expectancy \>= 12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 Exclusion Criteria: * Uncontrolled or current infection * Prior immunization with differentiation antigen peptides * Known standard therapy for the patient's disease that is potentially curative or proven capable of extending life expectancy * Any of the following prior therapies: * Chemotherapy =\< 4 weeks * Mitomycin C/nitrosoureas =\< 6 weeks * Immunotherapy =\<4 weeks * Biologic therapy =\< 4 weeks * Radiation therapy =\< 4 weeks * Radiation to \> 25% of bone marrow * Failure to fully recover from effects of prior chemotherapy regardless of interval since last treatment * New York Heart Association classification III or IV * Seizure disorder * Any of the following: * Pregnant women * Nursing women * Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, subcutaneous implants, or abstinence, etc.) * Other concurrent chemotherapy, immunotherapy, or radiotherapy * Active psychiatric disorder requiring medications (anti-psychotics) * Known central nervous system metastases or carcinomatous meningitis * History of other malignancy in last 5 years with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only (it is impossible to predict the effect of study treatment on other, potentially dormant malignant diseases) * Known immune deficiency (patients with known immune deficiencies will likely not be able to mount an immune response to the study vaccine)
References
Publications (0)
Data not yet available
No reference posted for this study.