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Home > "B" Clinical Trials Conditions > Biological Therapy in Treating Patients With Metastatic Melanoma  Biological Therapy in Treating Patients With Metastatic Melanoma
Biological Therapy in Treating Patients With Metastatic Melanoma
For Condition: Stage 4 Melanoma,Recurrent Melanoma
Status: Suspended
Sponsor(s): National Cancer Institute (NCI) , Fred Hutchinson Cancer Research Center
Synopsis: 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.
Details: OBJECTIVES: I. Assess the safety and toxicity of cellular adoptive immunotherapy using autologous CD8+ antigen specific T-cell clones in patients with metastatic melanoma. II. Estimate the duration of in vivo persistence of adoptively transferred CD8+ antigen specific cytotoxic T-cell clones. III. Evaluate the antitumor effects of CD8+ antigen specific T-cell clones in patients with metastatic melanoma. IV. Evaluate the development of host anti-HyTK T-cell responses in melanoma patients receiving HyTK transduced T-cell clones. PROTOCOL OUTLINE: Patients undergo leukapheresis to collect CD8+ cells, and surgery to harvest autologous tumor cells. CD8+ T-cells that demonstrate antigen specific cytotoxicity in vitro are transduced in vitro with the HyTK retrovirus containing a suicide marker gene. Patients receive 2 IV infusions of transduced CD8+ T-cell clones 1 week apart. In the absence of toxicity after a 2 week observation period, patients receive 3 additional infusions of nontransduced CD8+ T-cell clones given 3 weeks apart with increasing doses of low dose interleukin-2 subcutaneously. Patients are followed for approximately 1 year after the last infusion. PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histopathologically proven melanoma that is metastatic - No CNS metastases Bidimensionally measurable disease by palpation on clinical exam or radiographic imaging (x-ray, CT, or MRI) Surgically accessible site for tumor cell procurement (skin, subcutaneous nodule, or superficial node) and patient clinically eligible for such surgery --Prior/Concurrent Therapy-- At least 4 weeks since other prior investigational drug therapy and recovered 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 --Patient Characteristics-- Age: 18 to 75 Performance status: Karnofsky 70-100% Life expectancy: Greater than 16 weeks Hematopoietic: - WBC greater than 4,000/mm3 - Absolute neutrophil count greater than 2,000/mm3 - Platelet count greater than 100,000/mm3 - 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 - FEV1 at least 1.0 L - DLCO at least 45% predicted Other: - No active infection or oral temperature greater than 38.2 C within 72 hours of study - No systemic infection requiring chronic maintenance or suppressive therapy - HIV negative - No history of seizures - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use adequate contraception - Peripheral blood samples available weekly for 4 consecutive weeks
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CassianYee, Study Chair, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Additional Information:
Study ID Numbers: CDR0000064846; FHCRC-1017.01,NCI-V96-0920
Study Start Date: July 2002
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002786
Other Recurrent Melanoma Studies:
1. Combination Chemotherapy, Total-Body Irradiation, Peripheral Stem Cell Transplantation, and Lymphocyte Infusion in Treating Patients With Stage IV Melanoma
2. Vaccine Therapy in Treating Patients With Metastatic Melanoma
3. Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma
4. Melanoma Vaccine With or Without Sargramostim in Treating Patients With Stage IV Malignant Melanoma
5. Biological Therapy and Temozolomide in Treating Patients With Metastatic Melanoma
Related Studies:
Other Recurrent Melanoma Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Biological Therapy in Treating Patients With Metastatic Melanoma
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