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Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer



Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer

For Condition: Cancer
Status: Recruiting
Sponsor(s): St. Vincent Medical Center - Los Angeles ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Vaccines made from a patient's tumor tissue may make the body build an immune response to kill tumor cells. Chemotherapy combined with vaccine therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of cyclophosphamide plus tumor cell vaccine in treating patients who have metastatic cancer or cancer at high risk of recurrence.
Details: OBJECTIVES: - Determine the safety and clinical effects of autologous or allogeneic active-specific intralymphatic immunotherapy with a vaccine containing interferon alfa or interferon gamma-treated tumor cells followed by sargramostim (GM-CSF) in patients with advanced cancer. 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 on day -3. Patients also receive tumor cell vaccine intradermally on day 0 and sargramostim (GM-CSF) subcutaneously on days 1-9. 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. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 18-24 months.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed cancer not amenable to cure or long-term control by surgery, radiotherapy, chemotherapy, or hormonal manipulations, including the following tumor types: - Melanoma - Colon cancer - Lung cancer - Renal cancer - Breast cancer - Pancreatic cancer - Glioma - Mesothelioma - Metastatic disease or subclinical disease at high risk of recurrence - No brain metastases unresponsive to irradiation or surgery - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Not specified Menopausal status: - Not specified Performance status: - ECOG 0-2 OR - Karnofsky 70-100% Life expectancy: - At least 3 months Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Cardiovascular: - No prior or concurrent significant cardiovascular disease Pulmonary: - No prior or concurrent pulmonary disease Other: - No prior or concurrent autoimmune disease - No other prior or concurrent major medical illness - HIV negative - No clinical evidence of AIDS - Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy Endocrine therapy: - See Disease Characteristics - At least 4 weeks since prior hormonal therapy - No concurrent chronic steroid therapy Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy Surgery: - See Disease Characteristics
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
CharlesWiseman,  Study Chair,  St. Vincent Medical Center - Los Angeles

St. Vincent Medical Center - Los Angeles *Recruiting*
Los Angeles,  California,  90057-1901
United States
Recruiting Charles  Wiseman 213-484-7575


Additional Information:
Study ID Numbers:  CDR0000076913;  SVMC-ONC-222,NCI-V91-0075
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002475

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