Indomethacin Plus Biological Therapy in Treating Patients With Advanced Melanoma
|ClinicalTrials.gov Identifier: NCT00002535|
Recruitment Status : Completed
First Posted : July 29, 2004
Last Update Posted : June 26, 2013
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing. Combining biological therapies with indomethacin and cyclophosphamide may kill more tumor cells.
PURPOSE: Phase II trial to compare the effectiveness of indomethacin and biological therapy with or without cyclophosphamide in treating patients who have advanced melanoma that has not responded to previous therapy.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: aldesleukin Biological: lymphokine-activated killer cells Biological: therapeutic tumor infiltrating lymphocytes Drug: cyclophosphamide Drug: indomethacin||Phase 2|
OBJECTIVES: I. Determine whether indomethacin given prior to tumor removal can increase the number of tumor infiltrating lymphocytes (TIL) obtained from the tumor specimen of patients with advanced melanoma. II. Determine the efficacy of administering concurrent indomethacin to maximize immune effector cell function in situ during interleukin-2/TIL therapy in these patients. III. Determine the relationship between the phenotypic character of TIL (generated in culture from the patient's tumor) and the response to therapy. IV. Correlate the lytic activity or lymphokine production of TIL (generated in culture from the patient's tumor) with clinical response to therapy. V. Generate and use lymphokine-activated killer (LAK) cells in those patients who do not have TIL available for therapy and evaluate LAK cells in the same manner as TIL.
OUTLINE: Patients with resectable tumors and with adequate generation of TIL are treated on Regimen A; those with unresectable tumors or insufficient TIL are treated on Regimen B. The following acronyms are used: CTX Cyclophosphamide, NSC-26271 IL-2 Interleukin-2 (Cetus), NSC-373364 LAK Lymphokine-Activated Killer Cells TIL Tumor Infiltrating Lymphocytes Regimen A: Prostaglandin Inhibition Therapy plus Biological Response Modifier Therapy. Indomethacin; plus CTX; IL-2-activated TIL; IL-2. Regimen B: Prostaglandin Inhibition Therapy plus Biological Response Modifier Therapy. Indomethacin; plus IL-2-activated LAK; IL-2.
PROJECTED ACCRUAL: Up to 30 patients will be accrued over 3 years. If 0 of the first 10 patients, no more than 1 of the first 15 patients, or no more than 2 of the first 20 patients respond, accrual will cease.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||TUMOR INFILTRATING LYMPHOCYTE THERAPY FOR ADVANCED MELANOMA USING IMMUNOMODULATION, A PHASE II STUDY|
|Study Start Date :||July 1993|
|Study Completion Date :||July 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002535
|United States, Wisconsin|
|St. Luke's Medical Center|
|Milwaukee, Wisconsin, United States, 53215|
|Study Chair:||John P. Hanson, MD||St. Luke's Medical Center|