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Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer

This study is ongoing, but not recruiting participants.
Study NCT00002475.   Last updated on July 23, 2008.   Information provided by National Cancer Institute (NCI)

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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.

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 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 ]
Secondary Outcome Measure 
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
MEDLINE PMIDs 8368765
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  40
Start Date  April 1991
Completion Date
Eligibility 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
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 
Study Chair:     Charles L. Wiseman, MD, FACP        
Information Provided By National Cancer Institute (NCI)
Verification Date May 2006
First Received Date  November 1, 1999
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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