Tumor Vaccine and Interferon Gamma in Treating Patients With Refractory Epithelial Ovarian Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ovarian Cancer
Intervention: ALVAC-hB7.1 (Drug); recombinant interferon gamma (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: M.D. Anderson Cancer Center Official(s) and/or principal investigator(s):
Ralph S. Freedman, MD, PhD, Study Chair, Affiliation: M.D. Anderson Cancer Center
Summary
RATIONALE: 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.
PURPOSE: Phase I trial to study the effectiveness of a tumor cell vaccine and interferon
gamma in patients with refractory epithelial ovarian cancer.
Clinical Details
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
Study design: Treatment
Detailed description:
OBJECTIVES:
- 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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
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
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- Zubrod 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Lymphocyte count at least 500/mm^3
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
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
Locations and Contacts
University of Texas - MD Anderson Cancer Center, Houston, Texas 77030-4009, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: October 1997
Last updated: May 23, 2008
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