Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer; Colorectal Cancer; Kidney Cancer; Lung Cancer; Malignant Mesothelioma; Pancreatic Cancer
Intervention: allogeneic tumor cell vaccine (Drug); autologous tumor cell vaccine (Drug); cyclophosphamide (Drug); recombinant interferon alfa (Drug); recombinant interferon gamma (Drug); sargramostim (Drug); chemotherapy (Procedure); colony-stimulating factor therapy (Procedure); interferon therapy (Procedure); tumor cell-derivative vaccine therapy (Procedure)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: St. Vincent Medical Center - Los Angeles Official(s) and/or principal investigator(s):
Charles L. Wiseman, MD, FACP, Study Chair
Summary
RATIONALE: Drugs used in chemotherapy work in 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 combining cyclophosphamide with tumor
cell vaccine in treating patients who have metastatic cancer or cancer at high risk of
recurrence.
Clinical Details
Official title: A Trial of Active Intralymphatic Immunotherapy With Interferon-Treated Cells and Cyclophosphamide
Study design: Treatment
Primary outcome: Clinical response (patients with evaluable disease)Duration of response (patients with evaluable disease) Survival (patients with evaluable disease) Time to recurrence (patients without evaluable disease) Survival (patients without evaluable disease)
Detailed description:
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. 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.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 18-24
months.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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:
Colon cancer
Lung cancer
Renal cancer
Breast cancer
Pancreatic cancer
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
Locations and Contacts
St. Vincent Medical Center - Los Angeles, Los Angeles, California 90057-1901, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: April 1991
Last updated: December 25, 2007
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