Tumor Vaccine and Interferon Gamma in Treating Patients With Refractory Epithelial Ovarian Cancer
Intraperitoneal (IP) Autologous Therapeutic Tumor Vaccine AUT-OV-ALVAC-h.B7.1 Plus IP rIFN-gamma for Patients With Ovarian Cancer. A Pilot Study
4 other identifiers
interventional
12
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 1997
CompletedFirst Submitted
Initial submission to the registry
December 10, 1999
CompletedFirst Posted
Study publicly available on registry
August 25, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2004
CompletedJanuary 23, 2013
January 1, 2013
6.5 years
December 10, 1999
January 22, 2013
Conditions
Outcome Measures
Primary Outcomes (3)
Autologous tumor cell cytotoxicity lymphocyte (CTL)
Up to 7 years
Cytokine production (IFN gamma, IL-10, IL-2) by RT-PCR
Up to 7 years
Toxicity as assessed by NCI Common Terminology Criteria (CTC)
3 weeks
Study Arms (1)
Treatment (ALVAC-hB7.1, recombinant interferon gamma)
EXPERIMENTALPatients 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.
Interventions
Given IP
Correlative studies
Eligibility Criteria
You may qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ralph Freedman
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 1999
First Posted
August 25, 2003
Study Start
October 1, 1997
Primary Completion
April 1, 2004
Last Updated
January 23, 2013
Record last verified: 2013-01