Viewing Study NCT00002535



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Last Modification Date: 2024-10-26 @ 9:03 AM
Study NCT ID: NCT00002535
Status: COMPLETED
Last Update Posted: 2013-06-26
First Post: 1999-11-01

Brief Title: Indomethacin Plus Biological Therapy in Treating Patients With Advanced Melanoma
Sponsor: St Lukes Medical Center
Organization: National Cancer Institute NCI

Study Overview

Official Title: TUMOR INFILTRATING LYMPHOCYTE THERAPY FOR ADVANCED MELANOMA USING IMMUNOMODULATION A PHASE II STUDY
Status: COMPLETED
Status Verified Date: 2000-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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-2TIL therapy in these patients III Determine the relationship between the phenotypic character of TIL generated in culture from the patients tumor and the response to therapy IV Correlate the lytic activity or lymphokine production of TIL generated in culture from the patients 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
NCI-V93-0295 Registry Identifier PDQ Physician Data Query None
CDR0000078467 REGISTRY None None