Clinical trial · Interventional
Biological Therapy in Treating Patients With Metastatic Melanoma
Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD4+ Antigen-Specific T Cell Clones for Patients With Metastatic Melanoma
NCT00045357CI-TRIAL-00003936completedPhase 1ClinicalTrials.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: Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing. Treating a person's white blood cells in the laboratory and reinfusing them may cause a stronger immune response and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of biological therapy 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| therapeutic autologous lymphocytes | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic melanoma * HLA type expressing one of the following class II alleles: * DRB1\*0401 * DRB1\*0404 * DRB1\*1501 * DPB1\*0401 * DPB1\*0402 * Tumor expresses tyrosinase * Tumor expressing NY-ESO-1 and are HLA type DP4, DP2, or DR7 allowed * No CNS metastases * Prior CNS involvement allowed provided there is no evidence of CNS disease at least 2 months after treatment PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * Karnofsky 70-100% Life expectancy * More than 16 weeks Hematopoietic * WBC greater than 4,000/mm\^3 * Absolute neutrophil count greater than 2,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hematocrit greater than 30% Hepatic * SGOT no greater than 3 times upper limit of normal * INR no greater than 1.5 due to hepatic dysfunction * No significant hepatic dysfunction, defined as hepatic toxicity grade 2 or greater Renal * Creatinine no greater than 2.0 mg/dL OR * Creatinine clearance at least 60 mL/min * Calcium no greater than 12 mg/dL Cardiovascular * No significant cardiac abnormalities\*, defined by any 1 of the following: * Congestive heart failure * Clinically significant hypotension * Symptoms of coronary artery disease * Cardiac arrhythmias present on EKG requiring drug therapy NOTE: \*Patients with a history of cardiovascular disease or any of the above abnormalities undergo a cardiac evaluation, including a cardiac stress test and/or echocardiogram Pulmonary * No clinically significant pulmonary dysfunction * FEV1 at least 1.0 L OR * FEV1 at least 60% * DLCO at least 55% (corrected for hemoglobin) Immunologic * No acquired or hereditary immunodeficiency * No autoimmune disease * No active infection * No oral temperature greater than 38.2 degrees C within the past 72 hours * No systemic infection requiring chronic maintenance or suppressive therapy * HIV negative Other * No retinitis or choroiditis * No history of seizures * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy * No other concurrent immunotherapy (e.g., interleukins, interferons, melanoma vaccines, IV immunoglobulin, or expanded polyclonal tumor-infiltrating lymphocytes or lymphokine-activated killer therapy) Chemotherapy * At least 4 weeks since prior chemotherapy (standard or experimental) and recovered Endocrine therapy * No concurrent systemic steroids except for toxicity management Radiotherapy * At least 4 weeks since prior radiotherapy Surgery * Not specified Other * At least 4 weeks since prior immunosuppressive therapy * More than 4 weeks since prior experimental drugs and recovered * No concurrent pentoxifylline * No other concurrent investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.