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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00016289 |
RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill tumor cells. Giving interleukin-12 directly into the peritoneal cavity may kill cancer cells.
PURPOSE: Phase II trial to study the effectiveness of intraperitoneal interleukin-12 in treating patients who have ovarian epithelial cancer cancer or primary peritoneal cancer.
Condition | Intervention | Phase |
---|---|---|
Ovarian Cancer Peritoneal Cavity Cancer |
Drug: recombinant interleukin-12 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase II Study of Intraperitoneal Recombinant Human Interleukin-12 (rhIL-12) NSC (672423) in Patients With Peritoneal Carcinomatosis (Residual Disease <1cm) Associated With Ovarian Epithelial Cancer |
Study Start Date: | July 2001 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive interleukin-12 intraperitoneally once weekly. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease receive 2 additional courses.
Quality of life is assessed at baseline; prior to weeks 2, 4, 8, 12, and 16 of treatment; when patients are informed of their disease response; and then 2 weeks later.
Patients are followed every 2 months for 1 year and then every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed peritoneal carcinomatosis associated with ovarian epithelial or primary peritoneal epithelial carcinoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Kentucky | |
James Graham Brown Cancer Center at University of Louisville | |
Louisville, Kentucky, United States, 40202 | |
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Massachusetts General Hospital Cancer Center | |
Boston, Massachusetts, United States, 02114 | |
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104-4283 | |
United States, Texas | |
Hermann Hospital | |
Houston, Texas, United States, 77030 | |
M.D. Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-1439 | |
University of Texas Health Science Center - Houston | |
Houston, Texas, United States, 77030 |
Study Chair: | Renato Lenzi, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000068619, MDA-ID-00232, NCI-2251 |
Study First Received: | May 6, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00016289 |
Health Authority: | United States: Federal Government |
recurrent ovarian epithelial cancer peritoneal cavity cancer |
Ovarian cancer Interleukin-12 Ovarian Neoplasms Digestive System Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer |
Abdominal Neoplasms Recurrence Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Endocrine Gland Neoplasms |
Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Adjuvants, Immunologic Angiogenesis Inhibitors Pharmacologic Actions |
Adnexal Diseases Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |