Clinical trial · Interventional
Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma
A Phase I Study of Peptide Based Vaccine Therapy in Patients With High-Risk or Metastatic Melanoma
- 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 make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may kill more tumor cells. PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have metastatic 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 |
|---|---|---|---|
| MAGE-10.A2 | Biological | — | UNRESOLVED |
| MART-1 antigen | Biological | — | UNRESOLVED |
| NY-ESO-1 peptide vaccine | Biological | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
| tyrosinase peptide | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed high-risk stage III or IV melanoma
* Stage III disease less than 6 months after surgical resection
* Completed prior interferon alfa therapy OR
* Progressive disease or major adverse events during prior interferon alfa therapy
* Stage III disease at least 6 months after surgical resection
* Declined, failed, or completed prior standard therapy
* Stage IV disease
* Declined, failed, or completed prior standard therapy
* HLA-A2 positive
* No CNS metastases unless treated and stable
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 80-100%
Life expectancy:
* At least 4 months
Hematopoietic:
* Neutrophil count at least 1,500/mm3
* Lymphocyte count at least 500/mm3
* Platelet count at least 100,000/mm3
* Hemoglobin at least 9.0 g/dL (10.0 g/dL if less than 50 kg)
* No bleeding disorder
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
* No hepatitis B or C positivity
Renal:
* Creatinine no greater than 1.8 mg/dL
Cardiovascular:
* No New York Heart Association class III or IV heart disease
Other:
* HIV negative
* No other serious illness
* No serious infection requiring antibiotics
* No history of immunodeficiency disease or autoimmune disease
* No psychiatric or addictive disorder that would preclude study
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
* No prior bone marrow or stem cell transplantation
* At least 4 weeks since prior immunotherapy or biologic therapy
* No other concurrent immunotherapy or biologic therapy
Chemotherapy:
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
* No concurrent chemotherapy
Endocrine therapy:
* No concurrent systemic corticosteroids
* No concurrent steroids except topical or inhalational steroids
* Concurrent hormonal therapy allowed
Radiotherapy:
* At least 4 weeks since prior radiotherapy
Surgery:
* See Disease Characteristics
* At least 4 weeks since prior surgery
Other:
* At least 4 weeks since prior investigational agents
* Concurrent noncytotoxic anticancer therapy allowed
* No concurrent immunosuppressive therapy
* No concurrent antihistamines
* No concurrent non-steroidal anti-inflammatory drugs except in low doses for prevention of an acute cardiovascular event or pain controlReferences
Publications (0)
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