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Sponsored by: |
Tulane University Health Sciences Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00238186 |
RATIONALE: Biological therapies, such as denileukin diftitox, may be able to carry tumor-killing substances directly to tumor cells.
PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating patients with stage III or stage IV ovarian epithelial or primary peritoneal cancer.
Condition | Intervention | Phase |
---|---|---|
Ovarian Cancer Peritoneal Cavity Cancer |
Drug: denileukin diftitox |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
Official Title: | A Phase II Trial of Intravenous Ontak to Treat Epithelial Ovarian Cancer FIGO Stage III or Stage IV, or Extraovarian Peritoneal Carcinoma, Failing or Ineligible for First-Line Therapy |
Estimated Enrollment: | 60 |
Study Start Date: | December 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a non-randomized, multicenter study.
Patients receive denileukin diftitox IV over 1 hour once in week 1. Courses repeat monthly in the absence of disease progression or unacceptable toxicity. Patients receive 2 additional courses beyond achieving a documented response.
After completion of study treatment, patients are followed at 6 weeks, 3 months, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 20-60 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed* ovarian epithelial or primary peritoneal cancer
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
No history of autoimmune disease, including any of the following conditions:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Louisiana | |
Elliott-Elliott-Head Breast Cancer Research and Treatment Center | Recruiting |
Baton Rouge, Louisiana, United States, 70817 | |
Contact: Tyler Curiel, MD, MPH 504-988-8840 | |
Lakeview Regional Medical Center | Recruiting |
Covington, Louisiana, United States, 70433 | |
Contact: Tyler Curiel, MD, MPH 504-988-8840 tcuriel@tulane.edu | |
Tulane Cancer Center at Tulane University Hospital and Clinic | Recruiting |
New Orleans, Louisiana, United States, 70112 | |
Contact: Tyler Curiel, MD, MPH 504-988-8840 tcuriel@tulane.edu | |
Tulane-Lakeside Hospital | Recruiting |
Metairie, Louisiana, United States, 70001 | |
Contact: Tyler Curiel, MD, MPH 504-988-8840 tcuriel@tulane.edu |
Study Chair: | Tyler Curiel, MD, MPH | Tulane University Health Sciences Center |
Investigator: | Pui C. Cheng, MD | Tulane University Health Sciences Center |
Investigator: | Danny R. Barnhill, MD | Stanley S. Scott Cancer Center at Louisiana State University Medical Center - New Orleans |
Study ID Numbers: | CDR0000445063, TULCC-TC-01-4, TULCC-C0307 |
Study First Received: | October 12, 2005 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00238186 |
Health Authority: | Unspecified |
recurrent ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer peritoneal cavity cancer |
Ovarian cancer Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer Abdominal Neoplasms Dental Caries |
Recurrence Carcinoma Genital Diseases, Female Digestive System Diseases Interleukin-2 Denileukin diftitox Peritoneal Diseases Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Sensory System Agents Analgesics, Non-Narcotic Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions Adnexal Diseases |