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
  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
Biological: allogeneic tumor cell vaccine
Biological: autologous tumor cell vaccine
Biological: recombinant interferon alfa
Biological: recombinant interferon gamma
Biological: sargramostim
Drug: cyclophosphamide
Phase 2

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

Resource links provided by NLM:


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
Study Completion Date: June 2009
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
Publications:
Responsible Party: Charles L. Wiseman
ClinicalTrials.gov Identifier: NCT00002475     History of Changes
Other Study ID Numbers: SVMC-ONC-222, CDR0000076913, NCI-V91-0075
Study First Received: November 1, 1999
Last Updated: July 9, 2013
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

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Renal Cell
Kidney Neoplasms
Colorectal Neoplasms
Lung Neoplasms
Mesothelioma
Pancreatic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on July 26, 2014