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



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

For Condition: recurrent ovarian epithelial cancer
Status: Completed
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
RalphFreedman,  Study Chair,  M.D. Anderson Cancer Center

University of Texas - MD Anderson Cancer Center
Houston,  Texas,  77030-4009
United States
 


Additional Information:
Study ID Numbers:
  CDR0000065850;  MDA-ID-96253,NCI-T96-0106
Study Start Date: 
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004032

Other Recurrent Ovarian Epithelial Cancer Studies:
1. Chemotherapy With or Without Surgery in Treating Patients With Recurrent Ovarian Cancer

2. Gemcitabine With or Without cBR96-Doxorubicin Immunoconjugate (SGN-15) in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer

3. Cisplatin Plus Irinotecan in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer

4. Radiolabeled Monoclonal Antibody, Paclitaxel, and Interferon alfa in Treating Patients With Recurrent Ovarian Cancer

5. Tirapazamine Plus Cisplatin in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer

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

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