Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002475
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 10, 2013
Information provided by:
National Cancer Institute (NCI)

November 1, 1999
January 27, 2003
July 10, 2013
April 1991
December 2007   (Final data collection date for primary outcome measure)
  • 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)
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Complete list of historical versions of study NCT00002475 on Archive Site
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Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer
A Trial of Active Intralymphatic Immunotherapy With Interferon-Treated Cells and Cyclophosphamide

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.


  • 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.

Phase 2
Primary Purpose: Treatment
  • 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
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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June 2009
December 2007   (Final data collection date for primary outcome measure)


  • 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



  • 18 and over


  • Not specified

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 70-100%

Life expectancy:

  • At least 3 months


  • Not specified


  • Not specified


  • Not specified


  • No prior or concurrent significant cardiovascular disease


  • No prior or concurrent pulmonary disease


  • No prior or concurrent autoimmune disease
  • No other prior or concurrent major medical illness
  • HIV negative
  • No clinical evidence of AIDS
  • Not pregnant


Biologic therapy:

  • Not specified


  • 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


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy


  • See Disease Characteristics
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000076913 ( Registry Identifier: PDQ (Physician Data Query) )
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Charles L. Wiseman
St. Vincent Medical Center - Los Angeles
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Study Chair: Charles L. Wiseman, MD, FACP
National Cancer Institute (NCI)
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP