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Tumor Vaccine and Interferon Gamma in Treating Patients With Refractory Epithelial Ovarian Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004032
First Posted: August 25, 2003
Last Update Posted: January 23, 2013
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.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  Purpose
Phase I trial to study the effectiveness of a tumor cell vaccine and interferon gamma in patients with refractory epithelial ovarian cancer. 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

Condition Intervention Phase
Recurrent Ovarian Epithelial Cancer Biological: ALVAC-hB7.1 Biological: recombinant interferon gamma Other: laboratory biomarker analysis Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intraperitoneal (IP) Autologous Therapeutic Tumor Vaccine AUT-OV-ALVAC-h.B7.1 Plus IP rIFN-gamma for Patients With Ovarian Cancer. A Pilot Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Autologous tumor cell cytotoxicity lymphocyte (CTL) [ Time Frame: Up to 7 years ]
  • Cytokine production (IFN gamma, IL-10, IL-2) by RT-PCR [ Time Frame: Up to 7 years ]
  • Toxicity as assessed by NCI Common Terminology Criteria (CTC) [ Time Frame: 3 weeks ]

Enrollment: 12
Study Start Date: October 1997
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (ALVAC-hB7.1, recombinant interferon gamma)
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.
Biological: ALVAC-hB7.1
Given IP
Biological: recombinant interferon gamma
Given IP
Other Names:
  • Actimmune
  • gamma interferon
  • IFN-G
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

OBJECTIVES:

I. 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of ovarian epithelial carcinoma
  • Previously treated with an adequate course of platinum based chemotherapy
  • Evidence of intraabdominal disease
  • No significant adhesions
  • Performance status - Zubrod 0-2
  • Lymphocyte count at least 500/mm^3
  • Bilirubin no greater than 1.5 mg/dL
  • SGOT less than 2.5 times upper limit of normal
  • Creatinine no greater than 1.5 mg/dL
  • No major disorder of the cardiovascular system
  • No major disorder of the pulmonary system
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Successful placement of peritoneal catheter
  • No overt autoimmune disease
  • No concurrent chronic steroid therapy
  • No prior radiotherapy
  • Prior surgery allowed
  • Recovered from prior therapy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004032


Locations
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ralph Freedman M.D. Anderson Cancer Center
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004032     History of Changes
Other Study ID Numbers: NCI-2012-02255
MDA-ID-96253
U01CA062461 ( U.S. NIH Grant/Contract )
CDR0000065850 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: December 10, 1999
First Posted: August 25, 2003
Last Update Posted: January 23, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Vaccines
Interferons
Interferon-gamma
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents