Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer
|ClinicalTrials.gov Identifier: NCT00002475|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 10, 2013
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 or disease||Intervention/treatment||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|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Official Title:||A Trial of Active Intralymphatic Immunotherapy With Interferon-Treated Cells and Cyclophosphamide|
|Study Start Date :||April 1991|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||June 2009|
- Clinical response (patients with evaluable disease)
- Duration of response (patients with evaluable disease)
- Survival (patients with evaluable disease)
- Time to recurrence (patients without evaluable disease)
- Survival (patients without evaluable disease)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002475
|United States, California|
|St. Vincent Medical Center - Los Angeles|
|Los Angeles, California, United States, 90057-1901|
|Study Chair:||Charles L. Wiseman, MD, FACP|