Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Trial of Active Intralymphatic Immunotherapy With Interferon-Treated Cells and Cyclophosphamide |
- Clinical response (patients with evaluable disease) [ Designated as safety issue: No ]
- Duration of response (patients with evaluable disease) [ Designated as safety issue: No ]
- Survival (patients with evaluable disease) [ Designated as safety issue: No ]
- Time to recurrence (patients without evaluable disease) [ Designated as safety issue: No ]
- Survival (patients without evaluable disease) [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | April 1991 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
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| 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:
- 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
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
Additional Information:
Publications:
| Responsible Party: | Charles L. Wiseman |
| ClinicalTrials.gov Identifier: | NCT00002475 History of Changes |
| Other Study ID Numbers: | SVMC-ONC-222, CDR0000076913, NCI-V91-0075 |
| Study First Received: | November 1, 1999 |
| Last Updated: | May 21, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma, Renal Cell Kidney Neoplasms Colorectal Neoplasms Lung Neoplasms Mesothelioma Pancreatic Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Urologic Neoplasms Urogenital Neoplasms Kidney Diseases Urologic Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases |
ClinicalTrials.gov processed this record on June 18, 2013