Clinical trial · Interventional
Biological Therapy in Treating Patients With Metastatic Melanoma
PHASE I STUDY TO EVALUATE THE SAFETY OF CELLULAR ADOPTIVE IMMUNOTHERAPY USING GENETICALLY MODIFIED AND UNMODIFIED AUTOLOGOUS CD8+ TYROSINASE-SPECIFIC T CELLS FOR PATIENTS WITH METASTATIC MELANOMA
NCT00002786CI-TRIAL-00003429completedPhase 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: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase I/II 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| therapeutic tumor infiltrating lymphocytes | Biological | Therapeutic Tumor Infiltrating Lymphocytes | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histopathologically proven metastatic melanoma * No CNS metastases * HLA-A2 positive * Bidimensionally measurable disease by palpation on clinical exam or radiographic imaging (x-ray, CT scan, or MRI) * Surgically accessible site for tumor cell procurement (skin, subcutaneous nodule, or superficial node) and patient clinically eligible for such surgery PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * Karnofsky 80-100% 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 * Bilirubin no greater than 1.6 mg/dL * SGOT no greater than 150 IU (or no greater than 3 times normal) * Prothrombin time no greater than 1.5 times control Renal * Creatinine no greater than 2.0 mg/dL * Calcium no greater than 12 mg/dL Cardiovascular * No congestive heart failure * No clinically significant hypotension * No symptoms of coronary artery disease * No arrhythmia on EKG requiring drug therapy Pulmonary * No severe chronic obstructive pulmonary disease * FEV\_1 at least 1.0 L * DLCO at least 45% of predicted Other * No active infection or oral temperature greater than 38.2 degrees C within 72 hours of study * No systemic infection requiring chronic maintenance or suppressive therapy * HIV negative * No history of seizures * No retinitis or choroiditis * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use adequate contraception * Peripheral blood samples available weekly for 4 consecutive weeks PRIOR CONCURRENT THERAPY: Biologic therapy * At least 4 weeks since other prior immunotherapy Chemotherapy * 1 or 2 courses of cytoreductive chemotherapy allowed for bulky disease * At least 4 weeks since prior standard or investigational chemotherapy Endocrine therapy * At least 4 weeks since prior steroid therapy Radiotherapy * At least 4 weeks since prior radiotherapy Surgery * Not specified Other * At least 4 weeks since other prior investigational drug therapy and recovered
References
Publications (0)
Data not yet available
No reference posted for this study.