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| Descriptive Information Fields | |||||
| Brief Title † | Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer | ||||
| Official Title † | A Trial of Active Intralymphatic Immunotherapy With Interferon-Treated Cells and Cyclophosphamide | ||||
| Brief 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment | ||||
| Primary Outcome Measure † | 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 ] |
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| Secondary Outcome Measure † | |||||
| Condition † | Breast Cancer Colorectal Cancer Kidney Cancer Lung Cancer Malignant Mesothelioma Pancreatic Cancer |
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| Intervention † | Drug: allogeneic tumor cell vaccine Drug: autologous tumor cell vaccine Drug: cyclophosphamide Drug: recombinant interferon alfa Drug: recombinant interferon gamma Drug: sargramostim |
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| MEDLINE PMIDs | 8368765 | ||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 40 | ||||
| Start Date † | April 1991 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
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:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00002475 | ||||
| Organization ID | CDR0000076913 | ||||
| Secondary IDs †† | SVMC-ONC-222, NCI-V91-0075 | ||||
| Study Sponsor † | St. Vincent Medical Center - Los Angeles | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | May 2006 | ||||
| First Received Date † | November 1, 1999 | ||||
| Last Updated Date | July 23, 2008 | ||||