Interleukin-2 Plus Activated White Blood Cells in Treating Patients With Cancer That Has Not Responded to Chemotherapy or Radiation Therapy
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00019357
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Medicine Branch
🇺🇸Bethesda, Maryland, United States
Medicine Branch🇺🇸Bethesda, Maryland, United States