Melanoma (Skin) Clinical Trial
Official title:
TUMOR INFILTRATING LYMPHOCYTE THERAPY FOR ADVANCED MELANOMA USING IMMUNOMODULATION, A PHASE II STUDY
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.
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.
;
Primary Purpose: Treatment
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