Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002475
First received: November 1, 1999
Last updated: July 9, 2013
Last verified: November 2008

November 1, 1999
July 9, 2013
April 1991
December 2007   (final data collection date for 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 ]
Not Provided
Complete list of historical versions of study NCT00002475 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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.

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.

Interventional
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. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2009
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002475
SVMC-ONC-222, CDR0000076913, NCI-V91-0075
Not Provided
Charles L. Wiseman
St. Vincent Medical Center - Los Angeles
Not Provided
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