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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004032 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Biological: ALVAC-hB7.1 Biological: recombinant interferon gamma |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| 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 Start Date: | October 1997 |
OBJECTIVES:
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| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Ralph S. Freedman, MD, PhD | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | CDR0000065850, MDA-ID-96253, NCI-T96-0106 |
| Study First Received: | December 10, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004032 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent ovarian epithelial cancer |
|
Ovarian Neoplasms Interferon Type II Gonadal Disorders Interferons Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases |
Ovarian Epithelial Cancer Antiviral Agents Recurrence Genital Diseases, Female Ovarian Cancer Endocrinopathy Interferon-gamma, Recombinant Endocrine Gland Neoplasms |
|
Anti-Infective Agents Ovarian Neoplasms Interferon Type II Antineoplastic Agents Gonadal Disorders Interferons Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases |
Antiviral Agents Pharmacologic Actions Adnexal Diseases Genital Diseases, Female Neoplasms Neoplasms by Site Therapeutic Uses Endocrine Gland Neoplasms Interferon-gamma, Recombinant |
