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| Sponsored by: |
St. Vincent Medical Center - Los Angeles |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002475 |
Purpose
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.
| Condition | Intervention | Phase |
|
Breast Cancer Colorectal Cancer Kidney Cancer Lung Cancer Malignant Mesothelioma Pancreatic Cancer |
Drug: allogeneic tumor cell vaccine Drug: autologous tumor cell vaccine Drug: cyclophosphamide Drug: recombinant interferon alfa Drug: recombinant interferon gamma Drug: sargramostim |
Phase II |
| Genetics Home Reference related topics: | breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer Colorectal Cancer Kidney Cancer Lung Cancer Mesothelioma Pancreatic Cancer |
| ChemIDplus related topics: | Cyclophosphamide Sargramostim Granulocyte-macrophage colony-stimulating factor Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons Interferon gamma-1b |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Trial of Active Intralymphatic Immunotherapy With Interferon-Treated Cells and Cyclophosphamide |
| Estimated Enrollment: | 40 |
| Study Start Date: | April 1991 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, California | |||||
| St. Vincent Medical Center - Los Angeles | |||||
| Los Angeles, California, United States, 90057-1901 | |||||
| St. Vincent Medical Center - Los Angeles |
| Study Chair: | Charles L. Wiseman, MD, FACP |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000076913, SVMC-ONC-222, NCI-V91-0075 |
| First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002475 |
| Health Authority: | United States: Federal Government |
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