Clinical trial · Interventional
Biological Therapy in Treating Patients With Metastatic Melanoma
Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen Specific T Cell Clones Targeting Cancer Testis Antigens for Patients With 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: Biological therapies such as cellular adoptive immunotherapy use different ways to stimulate the immune system and stop cancer cells from growing. Treating a person's white blood cells in the laboratory and then 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 (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: * Histologically confirmed metastatic melanoma * Stage IV disease * HLA-A1, -A2, and -A3 positive * MAGE-1 or -3 positive by histology * Bidimensionally measurable disease by palpation on clinical examination, x-ray, or CT scan * No CNS metastases PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * Karnofsky 80-100% Life expectancy * More than 6 months Hematopoietic * Not specified Hepatic * Bilirubin ≤ 1.6 mg/dL * SGOT ≤ 3 times upper limit of normal * PT ≤ 1.5 times control Renal * Creatinine ≤ 2.0 mg/dL * Calcium ≤ 12 mg/dL Cardiovascular * No congestive heart failure * No clinically significant hypotension * No symptoms of coronary artery disease * No cardiac arrhythmias on electrocardiogram requiring drug therapy * Patients with prior cardiovascular disease or the presence of any of the above abnormalities undergo a cardiac evaluation, which may include a stress test and/or echocardiogram Pulmonary * No clinically significant pulmonary dysfunction by medical history or physical examination * FEV\_1 ≥ 60% of normal * DLCO ≥ 55% (corrected for hemoglobin) Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No retinitis or choroiditis * No active infections or oral temperature greater than 38.2 degrees Celsius within the past 72 hours * No systemic infection requiring chronic maintenance or suppressive therapy PRIOR CONCURRENT THERAPY: Biologic therapy * No other concurrent immunotherapy (e.g., other interleukins, interferons, melanoma vaccines, intravenous immunoglobulin, or expanded polyclonal tumor-infiltrating lymphocytes or lymphokine-activated killer cell therapy) Chemotherapy * At least 3 weeks since prior standard or experimental chemotherapy * 1-2 courses of prior cytoreductive chemotherapy for bulky disease allowed Endocrine therapy * No concurrent systemic steroids (except for toxicity management) Radiotherapy * At least 3 weeks since prior radiotherapy Surgery * Not specified Other * At least 3 weeks since prior immunosuppressive therapy * No concurrent pentoxifylline * No other concurrent investigational agents
References
Publications (0)
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