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

National Cancer Institute (NCI)

Status and phase: Completed; Phase 1

Conditions: Recurrent Ovarian Epithelial Cancer

Treatments: Biological: ALVAC-hB7.1; Other: laboratory biomarker analysis; Biological: recombinant interferon gamma

Study type: Interventional

Funder types: NIH

Identifiers

NCT00004032

NCI-2012-02255

MDA-ID-96253

U01CA062461 (U.S. NIH Grant/Contract)

CDR0000065850 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Treatment (ALVAC-hB7.1, recombinant interferon gamma)

Experimental group

Description:

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.

Treatment:

Biological: recombinant interferon gamma

Other: laboratory biomarker analysis

Biological: ALVAC-hB7.1