Interleukin-2 Plus Activated White Blood Cells in Treating Patients With Cancer That Has Not Responded to Chemotherapy or Radiation Therapy
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining white blood cells, which have been activated by a vaccine, with interleukin-2 may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of interleukin-2 plus activated white blood cells in treating patients with cancer that has not responded to chemotherapy or radiation therapy.
|Unspecified Adult Solid Tumor, Protocol Specific||Biological: aldesleukin Biological: therapeutic autologous lymphocytes Biological: therapeutic tumor infiltrating lymphocytes||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Cellular Immunotherapy With Autologous T Lymphocytes Stimulated With the Patient's Tumor-Specific Mutated Ras Peptides|
|Study Start Date:||June 1998|
OBJECTIVES: I. Determine the feasibility of expansion and the reinfusion of specific T-cell lines (peptide-specific activated lymphocytes), in combination with interleukin-2, in patients who were vaccinated with ras peptides. II. Assess immunologic status or antitumor response that may occur with this treatment in these patients.
OUTLINE: Autologous peptide-specific activated lymphocytes (PAL), previously harvested from the patient following vaccination on a different protocol, are expanded and reinfused intravenously; this is followed by a 4 hour observation period. Patients then receive interleukin-2 (IL-2) administered subcutaneously 5 days a week for 2 weeks; the first dose of IL-2 is administered at least 4 hours after PAL infusion. Patients are followed once a month for 2 months after treatment.
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019357
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Samir N. Khleif, MD||National Cancer Institute (NCI)|