Clinical trial · Interventional
Vaccine Therapy and GM-CSF With or Without Low-Dose Aldesleukin in Treating Patients With Stage II, Stage III, or Stage IV Melanoma
Melanoma Peptide Vaccines (MART1 Analog, gp100 and Survivin) With GM-CSF and Low-Dose IL-2 as Immune Adjuvants, A Pilot Study
- 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)
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Aldesleukin may stimulate the white blood cells to kill tumor cells. Giving vaccine and different doses of GM-CSF mixed in incomplete Freund's adjuvant, with or without aldesleukin, may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and how well giving vaccine therapy together with GM-CSF, with or without low-dose aldesleukin, works in treating patients with stage II, stage III, or stage IV melanoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GM-CSF | Biological | — | UNRESOLVED |
| gp100 antigen | Biological | — | UNRESOLVED |
| IL-2 | Biological | — | UNRESOLVED |
| MART-1 antigen | Biological | — | UNRESOLVED |
| MART-1a peptide | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MART1 Analog, gp100 and Survivin
- interventionNames
- Biological: MART-1 antigen
- Biological: IL-2
- Biological: gp100 antigen
- Biological: GM-CSF
- Biological: MART-1a peptide
Primary outcomes (2)
- measure
- Percent changes in peptide vaccine-specific immune responses (tetramer frequencies) from pretreatment levels
- timeFrame
- 12 weeks
- measure
- Number and severity of hematologic and nonhematologic toxicities observed at each dose level
- timeFrame
- 12 weeks
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed melanoma * Stage II-IV disease * Completely resected disease * No known standard therapy that is potentially curative or proven capable of extending life expectancy exists * HLA-A2 positive PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 12 weeks * ANC ≥ 1,500/mm³ * Hemoglobin \> 10 g/dL * Platelet count ≥ 50,000/mm³ * AST ≤ 3 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 3 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled or current infection * No known allergy to vaccine or immunoadjuvant components * No known immune deficiency PRIOR CONCURRENT THERAPY: * No chemotherapy within the past 4 weeks and recovered * No biologic therapy within the past 4 weeks * No radiation therapy within the past 4 weeks
References
Publications (0)
Data not yet available