Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed Any age NCI MDA-ID-96253 NCI-T96-0106, NCT00004032, T96-0106

Objectives

1. 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.

Entry Criteria

Disease Characteristics:

• Diagnosis of ovarian epithelial carcinoma



• Previously treated with an adequate course of platinum based chemotherapy



• Evidence of intraabdominal disease



• No significant adhesions

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

Patient Characteristics:

Age:

• Any age

Performance status:

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Lymphocyte count at least 500/mm³

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

Expected Enrollment

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

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.

Freedman RS, Platsoucas CD, Scholm J, et al.: Infection of fresh epithelial ovarian carcinoma (EOC) cells with a canarypox construct ALVAC-hB7.1 after in vitro treatment with rIFN-gamma and early clincial results. [Abstract] Proc Am Assoc Cancer Res 40: A3792, 1999.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Ralph Freedman, MD, PhD, Protocol chair		Ph: 713-792-2764; 800-392-1611 Email: rfreedma@mdanderson.org

Registry Information
Official Title		Intraperitoneal (IP) Autologous Therapeutic Tumor Vaccine AUT-OV-ALVAC-hB7.1 plus IP rIFN-gamma for Patients with Ovarian Cancer. A Pilot Study
Trial Start Date		1997-10-16
Registered in ClinicalTrials.gov		NCT00004032
Date Submitted to PDQ		1997-10-15
Information Last Verified		2004-04-13
NCI Grant/Contract Number		CA16672, CA62461

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