Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer

Phase 2

Completed

• Conditions: Breast Cancer; Colorectal Cancer; Kidney Cancer; Lung Cancer; Malignant Mesothelioma; Pancreatic Cancer

• Registration Number: NCT00002475
• Lead Sponsor: St. Vincent Medical Center - Los Angeles

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.

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.

Study Timeline

• Study Start: 1991-04
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2007-12
• Status Verified: 2008-11
• Study Completion: 2009-06
• Last Update Submitted: 2013-07-09
• Last Update Posted: 2013-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

St. Vincent Medical Center - Los Angeles; 🇺🇸 Los Angeles, California, United States