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Clinical Trial Name - Biological Therapy in Treating Patients With Metastatic Melanoma
| Original Study ID : CDR0000256451 |
| Secondary ID : Array |
| NCT ID : NCT00045149 |
| Brief Title : Biological Therapy in Treating Patients With Metastatic Melanoma |
| Official Title : 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 |
| Brief Summary : 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. |
| Source : National Cancer Institute (NCI) |
| Detailed Description : OBJECTIVES: Primary - Determine the safety and toxicity of cellular adoptive immunotherapy comprising autologous CD8+ cytotoxic T-lymphocyte clones targeting cancer-testis antigens in patients with metastatic melanoma. - Determine the duration of in vivo persistence of this therapy in these patients. Secondary - Evaluate the antitumor effects of this therapy in these patients. OUTLINE: Patients undergo leukapheresis to obtain peripheral blood mononuclear cells and then CD8+ cytotoxic T-lymphocyte (CTL) clones are generated ex vivo. Patients receive cellular adoptive immunotherapy comprising autologous CD8+ CTL clones targeting cancer testis antigens IV over 30 minutes on day 1. Patients also receive interleukin-2 subcutaneously every 12 hours on days 1-14 of courses 2-4. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients who demonstrate a clinical response after completion of the fourth course are eligible to receive additional T-cell infusions. Patients are followed for 9 months. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 3 years. |
| Overall Status : Active, not recruiting |
| Start Date : October 2002 |
| Official Title : Phase 1 |
| Phase : Interventional |
| Study Design : Treatment, Open Label |
| Verification Date : January 2008 |
| First Received Date : September 6, 2002 |
| Trial Eligibility |
| Criteria : 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 |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : 75 Years |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Fred Hutchinson Cancer Research Center |
| City : Seattle |
| State : Washington |
| Zip Code : 98109-1024 |
| Country : United States |
| Interventions |
| Type : Biological |
| Name : aldesleukin |
| Type : Biological |
| Name : therapeutic tumor infiltrating lymphocytes |
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