Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Stage IV or Recurrent Melanoma
Vaccine Biotherapy of Cancer: Tumor Cells and Dendritic Cells as Active Specific Immunotherapy of Patients With Metastatic Melanoma
NCT00012064CI-TRIAL-00013607completedPhase 1 / Phase 2ClinicalTrials.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)
RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV or recurrent 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| therapeutic autologous dendritic cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Biological/Vaccine
- description
- Biological/Vaccine: therapeutic autologous dendritic cells. Apheresis procedure collects peripheral blood mononuclear cells (PBMC) for the production of dendritic cell, which are admixed with irradiated tumor cells from autologous tumor cell line for vaccine product.
- interventionNames
- Biological: therapeutic autologous dendritic cells
Primary outcomes (2)
- measure
- To determine the safety of administration of irradiated autologous tumor cells that have been incubated in vitro with gamma interferon, and subsequently injected subcutaneously with autologous dendritic cells and GMCSF
- timeFrame
- treatment
- measure
- To determine the frequency of conversion of delayed tumor hypersensitivity (DTH) tests with irradiated autologous tumor cells, in patients who received an autologous dendritic cell/tumor cell vaccine with GMCSF
- timeFrame
- treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed stage IV or recurrent melanoma * Metastatic disease confirmed by MRI or CT scan * Planned resection of tumor * No active CNS metastases * Radiographically confirmed lack of CNS disease progression * No requirement for pharmacologic doses of corticosteroids PATIENT CHARACTERISTICS: Age: * Over 16 Performance status: * ECOG 0-2 Life expectancy: * At least 4 months Hematopoietic: * Hematocrit greater than 25% * Platelet count greater than 100,000/mm\^3 * No ongoing transfusion requirements * No active blood clotting or bleeding diathesis Hepatic: * Bilirubin no greater than 2.0 mg/dL * Albumin at least 3.0 g/dL Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No underlying cardiac disease associated with known myocardial dysfunction * No unstable angina related to atherosclerotic cardiovascular disease Other: * No other malignancy within the past 5 years except for carcinoma in situ, basal cell carcinoma, or localized squamous cell skin cancer * No active, eminently life-threatening infection or medical condition * Adequate venous access * Not pregnant * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Other prior putative vaccines allowed * Recovered from prior biologic therapy * No other concurrent biologic therapy except epoetin alfa for patients with hematocrit less than 36% Chemotherapy: * At least 3 weeks since prior chemotherapy and recovered * No concurrent chemotherapy Endocrine therapy: * See Disease Characteristics * No concurrent endocrine therapy Radiotherapy: * At least 3 weeks since prior radiotherapy (including whole brain radiotherapy) and recovered * No concurrent radiotherapy Surgery: * See Disease Characteristics * Recovered from prior surgery Other: * Concurrent bisphosphonates allowed for patients with lytic bone metastases * No concurrent digoxin or other medications designed to improve cardiac output * No other concurrent investigational therapy
References
Publications (1)
- RESULTDillman RO, Schiltz PM, Selvan R, et al.: Patient-specific cancer vaccine of cultured autologous tumor cells and autologous dendritic cells. [Abstract] J Immunother 24 (5): S5, 2001.