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Mesothelioma Related Clinical Trials:
A Trial of Active Intralymphatic Immunotherapy With Interferon-Treated Cells and Cyclophosphamide
Status: Active
Sponsors and Collaborators: St. Vincent Medical Center - Los Angeles; National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
Government Identifier: NCT00002475
Condition: Breast Cancer; Colorectal Cancer; Kidney Cancer; Lung Cancer; Malignant Mesothelioma; Pancreatic Cancer
Intervention: Drug: allogeneic tumor cell vaccine; Drug: autologous tumor cell vaccine; Drug: cyclophosphamide; Drug: recombinant interferon alfa; Drug: recombinant interferon gamma; Drug: sargramostim; Procedure: chemotherapy; Procedure: colony-stimulating factor therapy; Procedure: interferon therapy; Procedure: tumor cell-derivative vaccine therapy
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.
| Study Type: | Interventional |
| Study Design: | 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 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
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:
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations:
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002475Locations
| United States, California | |||||
| St. Vincent Medical Center - Los Angeles | |||||
| Los Angeles, California, United States, 90057-1901 | |||||
Sponsors and Collaborators
| St. Vincent Medical Center - Los Angeles |
Investigators
| Study Chair: | Charles L. Wiseman, MD, FACP |
Additional Information:
Publications of Results:| Wiseman C, Presant C, Rao R, Smith J. Clinical responses to intralymphatic whole-cell melanoma vaccine augmented by in vitro incubation with alpha-interferon. Ann N Y Acad Sci. 1993 Aug 12;690:388-91. No abstract available. |
| Study ID Numbers: | CDR0000076913, SVMC-ONC-222, NCI-V91-0075 |
| First Received: | November 1, 1999 |
| Last Updated: | March 8, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002475 |
| Health Authority: | United States: Federal Government |
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