Clinical trial · Interventional
Combined Modality Treatment for Patients With Stage IV Melanoma
Combined Modality Treatment for Patients With Stage IV Melanoma: Cyclophosphamide and a Dendritic Cell Vaccine Loaded With Killed Allogeneic Melanoma Cells
NCT00313235CI-TRIAL-00010705completedPhase 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)
The purpose of this study is to test a combined treatment using cyclophosphamide and a novel dendritic cell vaccine in patients with 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 |
|---|---|---|---|
| Malignant Melanoma Stage IV | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DC Vaccine and Cyclophosphamide | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DC Vaccine and Cyclophosphamide
- description
- Autologous dendritic cells (DC) are derived from PBMC, cultured with cytokines, pulsed ex vivo with irradiated allogeneic (Colo 829) melanoma cells. About 15 x 10\^6 dendritic cells will be injected subcutaneously, in 3 separate sites (3.3 ml/site). Patients will receive a total of 7 doses of the vaccination. Each individual dose will be administered at weeks: 0, 2, 4, 6, 11, 14, and 18. Patients with SD, PR according to RECIST criteria may receive 4 more vaccines at 36, 48, 60 and 72 weeks. Patients with CR will receive 4 additional vaccines at 36, 48, 72, and 96 weeks. CPA will be administered 300mg/m2, intravenously over a 2-hour infusion 24 hours prior to DC vaccinations # 1, 3, 5, 6 and 7. Frequency of CPA administration might be increased based on their T cell measure.
- interventionNames
- Biological: DC Vaccine and Cyclophosphamide
Primary outcomes (3)
- measure
- Safety and tolerability of the combination of DC vaccination and CPA therapy in human subjects
- timeFrame
- 2 Years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Stage M1a, M1b, M1c biopsy proven metastatic melanoma. * Ages 21-75. * Karnofsky performance status greater than/equal to 80%. * Measurable metastatic lesions by physical exam or scans. * Acceptable CBC and blood chemistry results. * Adequate hepatic and renal function. * No active CNS metastatic disease. If CNS history is present, lesions must have been resected by surgery and/or gamma knife irradiation at least 3 months prior to study entry. The total number of CNS lesions at diagnosis should not exceed 3. * Written informed consent. Exclusion Criteria: * Patients that have received more than 8 cycles of chemotherapy for metastatic melanoma. * Patients who have received chemotherapy less than 4 weeks before beginning the trial. * Patients who have received IFN alpha-2b or GM-CSF less than 4 weeks before beginning the trial. * Patients who have received high-dose IL-2 less than 4 weeks before beginning the trial. * Patients diagnosed with more than 3 CNS metastatic melanoma lesions. * More than 5 hepatic lesions or any hepatic lesion larger than 5 cm. * Baseline serum LDH greater than 1.1 times the upper limit of normal. * Patients who are HIV positive. * Patients who are pregnant. * Patients who have receive corticosteroids or other agents less than 4 weeks before beginning the trial. * Patients with asthma, angina pectoris or congestive heart failure. * Patients with autoimmune disease such as lupus erythematosus, rheumatoid arthritis or thyroiditis. * Patients with active infections including viral hepatitis. * Patients with a history of any other neoplastic disease less than 5 years ago (carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin, however, can be admitted to the study).
References
Publications (0)
Data not yet available
No reference posted for this study.