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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 1
Not Enrolling
Recurrent Ovarian Epithelial Cancer

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Trial Information

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


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.

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Autologous tumor cell cytotoxicity lymphocyte (CTL)

Outcome Time Frame:

Up to 7 years

Safety Issue:


Principal Investigator

Ralph Freedman

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

October 1997

Completion Date:

Related Keywords:

  • Recurrent Ovarian Epithelial Cancer
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial



M D Anderson Cancer Center Houston, Texas  77030