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Cyclophosphamide Plus Vaccine Therapy in Treating Patients With Advanced Cancer

This study is ongoing, but not recruiting participants.

Sponsored by: St. Vincent Medical Center - Los Angeles
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002475
  Purpose

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 Intervention Phase
Breast Cancer
Colorectal Cancer
Kidney Cancer
Lung Cancer
Malignant Mesothelioma
Pancreatic Cancer
Drug: allogeneic tumor cell vaccine
Drug: autologous tumor cell vaccine
Drug: cyclophosphamide
Drug: recombinant interferon alfa
Drug: recombinant interferon gamma
Drug: sargramostim
Phase II

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer    Colorectal Cancer    Kidney Cancer    Lung Cancer    Mesothelioma    Pancreatic Cancer   

Drug Information available for:   Cyclophosphamide    Sargramostim    Granulocyte-macrophage colony-stimulating factor    Interferon alfa-n1    Interferon alfa-2a    Interferon alfa-2b    Interferons    Interferon gamma-1b   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Trial of Active Intralymphatic Immunotherapy With Interferon-Treated Cells and Cyclophosphamide

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment:   40
Study Start Date:   April 1991
Primary Completion Date:   December 2007 (Final data collection date for primary outcome measure)

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002475

Locations
United States, California
St. Vincent Medical Center - Los Angeles    
      Los Angeles, California, United States, 90057-1901

Sponsors and Collaborators
St. Vincent Medical Center - Los Angeles

Investigators
Study Chair:     Charles L. Wiseman, MD, FACP    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000076913, SVMC-ONC-222, NCI-V91-0075
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002475
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III colon cancer  
stage IV colon cancer  
stage IV breast cancer  
stage IIIA breast cancer  
recurrent breast cancer  
stage IIIB breast cancer  
recurrent non-small cell lung cancer  
stage II pancreatic cancer  
stage III pancreatic cancer  
recurrent pancreatic cancer  
recurrent colon cancer  
stage III renal cell cancer  
stage IV renal cell cancer
recurrent renal cell cancer
extensive stage small cell lung cancer
recurrent small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IIIC breast cancer
stage IV non-small cell lung cancer
pulmonary carcinoid tumor
recurrent malignant mesothelioma
stage IV pancreatic cancer

Study placed in the following topic categories:
Thoracic Neoplasms
Interferon Type II
Pancreatic Neoplasms
Colonic Diseases
Urogenital Neoplasms
Urologic Neoplasms
Rectal Diseases
Lung Neoplasms
Kidney Diseases
Breast Diseases
Endocrine Gland Neoplasms
Non-small cell lung cancer
Digestive System Neoplasms
Breast Neoplasms
Endocrine System Diseases
Renal cancer
Carcinoma
Carcinoma, Small Cell
Lung Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Carcinoid Tumor
Interferon Alfa-2a
Carcinoma, Non-Small-Cell Lung
Interferon Alfa-2b
Neoplasms, Glandular and Epithelial
Interferon-gamma, Recombinant
Interferon Type I, Recombinant
Gastrointestinal Diseases
Cyclophosphamide

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Anti-Infective Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Neoplasms, Mesothelial
Growth Substances
Physiological Effects of Drugs
Immunosuppressive Agents
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Growth Inhibitors
Angiogenesis Modulating Agents
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on November 20, 2008




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