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Tumor Vaccine and Interferon Gamma in Treating Patients With Refractory Epithelial Ovarian Cancer
This study has been completed.
Study NCT00004032   Information provided by National Cancer Institute (NCI)
First Received: December 10, 1999   Last Updated: February 6, 2009   History of Changes

December 10, 1999
February 6, 2009
October 1997
 
 
 
Complete list of historical versions of study NCT00004032 on ClinicalTrials.gov Archive Site
 
 
 
Tumor Vaccine and Interferon Gamma in Treating Patients With Refractory Epithelial Ovarian Cancer
Intraperitoneal (IP) Autologous Therapeutic Tumor Vaccine AUT-OV-ALVAC-hB7.1 Plus IP rIFN-Gamma for Patients With Ovarian Cancer. A Pilot Study

RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to and kill their tumor cells. Combining vaccine therapy with interferon gamma may be a more effective treatment for epithelial ovarian cancer.

PURPOSE: Phase I trial to study the effectiveness of a tumor cell vaccine and interferon gamma in patients with refractory epithelial ovarian cancer.

OBJECTIVES:

  • Determine whether intraperitoneal (IP) injections of epithelial ovarian carcinoma cells infected with ALVAC-hB7.1 and IP interferon gamma have acceptable toxicity and produce any clinical responses in patients with refractory ovarian epithelial cancer.

OUTLINE: This is a dose-escalation study of ALVAC-hB7.1 infected tumor cells.

Patients receive ALVAC-hB7.1 infected tumor cells intraperitoneally (IP) on days 4, 11, and 18. Patients also receive interferon gamma IP on days 8, 10, 15, and 17. In the absence of disease progression, up to 6 courses of therapy may be given. If insufficient tumor cells are available to continue treatment with tumor cell derived vaccine, interferon gamma may be given alone.

Cohorts of 3 to 6 patients receive escalating doses of ALVAC-hB7.1 infected tumor cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 6 months until disease progression.

PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.

Phase I
Interventional
Treatment
Ovarian Cancer
  • Biological: ALVAC-hB7.1
  • Biological: recombinant interferon gamma
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Diagnosis of ovarian epithelial carcinoma
  • Previously treated with an adequate course of platinum based chemotherapy
  • Evidence of intraabdominal disease
  • No significant adhesions

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Lymphocyte count at least 500/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • SGOT less than 2.5 times upper limit of normal

Renal:

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular:

  • No major disorder of the cardiovascular system

Pulmonary:

  • No major disorder of the pulmonary system

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Successful placement of peritoneal catheter
  • No overt autoimmune disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • No concurrent chronic steroid therapy

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • Prior surgery allowed

Other:

  • Recovered from prior therapy
Female
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004032
 
CDR0000065850, MDA-ID-96253, NCI-T96-0106
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Ralph S. Freedman, MD, PhD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
April 2004

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