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Phase II Pilot Study of Cyclophosphamide and Active Intralymphatic Immunotherapy With a Vaccine Containing Interferon alfa or Interferon gamma-Treated Tumor Cells Followed By Sargramostim (GM-CSF) in Patients With Advanced Cancer
Alternate Title Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer
Objectives
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Patient Characteristics: Age:
Sex:
Menopausal status:
Performance status: Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
Expected Enrollment 40A total of 20-40 patients will be accrued for this study within 18-24 months. Outcomes Primary Outcome(s)Clinical response (patients with evaluable disease) Outline This is a pilot study. Patients are stratified by tumor type. Tumor tissue is removed from the patient and incubated with interferon alfa or interferon gamma for 72-96 hours. (If autologous tumor cells are not available, an allogeneic vaccine is prepared.) Harvested activated cells are irradiated immediately prior to use. Patients receive cyclophosphamide IV. 48-72 hours after cyclophosphamide administration, patients receive tumor cell vaccine intradermally. Patients also receive sargramostim (GM-CSF) subcutaneously prior to vaccine administration and once daily for the next 8 days. Treatment repeats every 2 weeks for 3 courses in the absence of unacceptable toxicity. Patients with responding or stable disease after completion of course 3 may receive additional courses. Patients are followed for survival. Published ResultsWiseman C, Presant C, Rao R, et al.: Clinical responses to intralymphatic whole-cell melanoma vaccine augmented by in vitro incubation with alpha-interferon. Ann N Y Acad Sci 690: 388-91, 1993.[PUBMED Abstract] Trial Lead Organizations St. Vincent Medical Center - Los Angeles
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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