Tumor Vaccine and Interferon Gamma in Treating Patients With Refractory Epithelial Ovarian Cancer
NCT ID: NCT00004032
Last Updated: 2013-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
1997-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
ALVAC-hB7.1
Given IP
recombinant interferon gamma
Given IP
laboratory biomarker analysis
Correlative studies
Interventions
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ALVAC-hB7.1
Given IP
recombinant interferon gamma
Given IP
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Ralph Freedman
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Other Identifiers
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MDA-ID-96253
Identifier Type: -
Identifier Source: secondary_id
CDR0000065850
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-02255
Identifier Type: -
Identifier Source: org_study_id
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