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

January 22, 2013 updated by: National Cancer Institute (NCI)

Intraperitoneal (IP) Autologous Therapeutic Tumor Vaccine AUT-OV-ALVAC-h.B7.1 Plus IP rIFN-gamma for Patients With Ovarian Cancer. A Pilot Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: laboratory biomarker analysis
Correlative studies
Biological: ALVAC-hB7.1
Given IP
Biological: recombinant interferon gamma
Given IP
Other Names:
  • Actimmune
  • gamma interferon
  • IFN-G

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Ralph Freedman, M.D. Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1997

Primary Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

December 10, 1999

First Submitted That Met QC Criteria

August 22, 2003

First Posted (Estimate)

August 25, 2003

Study Record Updates

Last Update Posted (Estimate)

January 23, 2013

Last Update Submitted That Met QC Criteria

January 22, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-02255
  • U01CA062461 (U.S. NIH Grant/Contract)
  • MDA-ID-96253
  • CDR0000065850 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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