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| Sponsor: | 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 |
Biological: allogeneic tumor cell vaccine Biological: autologous tumor cell vaccine Biological: recombinant interferon alfa Biological: recombinant interferon gamma Biological: sargramostim Drug: cyclophosphamide |
Phase II |
| 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 | |
| Study Chair: | Charles L. Wiseman, MD, FACP |
More Information
| Responsible Party: | ( Charles L. Wiseman ) |
| Study ID Numbers: | CDR0000076913, SVMC-ONC-222, NCI-V91-0075 |
| Study First Received: | November 1, 1999 |
| Last Updated: | June 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002475 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III colon cancer stage IV colon cancer stage IV breast cancer stage IIIA breast cancer recurrent breast cancer stage IIIB breast cancer recurrent non-small cell lung cancer stage II pancreatic cancer stage III pancreatic cancer recurrent pancreatic cancer recurrent colon cancer stage III renal cell cancer |
stage IV renal cell cancer recurrent renal cell cancer extensive stage small cell lung cancer recurrent small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IIIC breast cancer stage IV non-small cell lung cancer pulmonary carcinoid tumor recurrent malignant mesothelioma stage IV pancreatic cancer |
|
Thoracic Neoplasms Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Interferon Type II Pancreatic Neoplasms Colonic Diseases Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Rectal Diseases Neoplasms by Site Lung Neoplasms Therapeutic Uses Angiogenesis Modulating Agents Kidney Diseases |
Breast Diseases Endocrine Gland Neoplasms Digestive System Neoplasms Breast Neoplasms Endocrine System Diseases Carcinoma Neoplasms Lung Diseases Gastrointestinal Neoplasms Pancreatic Diseases Interferon Alfa-2a Neoplasms, Glandular and Epithelial Interferon-gamma, Recombinant Interferon Type I, Recombinant Immunologic Factors |
