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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00357448 |
RATIONALE: Combinations of biological substances in denileukin diftitox may be able to carry tumor-killing substances directly to tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of denileukin diftitox when given as an intraperitoneal infusion in treating patients with advanced refractory ovarian epithelial cancer, primary peritoneal cavity cancer, or fallopian tube cancer.
Condition | Intervention | Phase |
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Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Biological: denileukin diftitox |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
Official Title: | Phase I Dose Escalation Study of Intraperitoneal (I.P.) ONTAK Administered to Patients With Advanced Stage Ovarian Cancer |
Estimated Enrollment: | 18 |
Study Start Date: | April 2005 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a non-randomized, dose-escalation study.
Patients receive intraperitoneal denileukin diftitox over 15 minutes on days 1-3. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of denileukin diftitox until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
After the completion of study treatment, patients are followed at 1 and 2 weeks, monthly for 3 months, and then at 6 months.
PROJECTED ACCRUAL: A total of 18 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 carcinoma, primary peritoneal cavity carcinoma, or fallopian tube epithelial carcinoma with any of the following histologic epithelial cell types :
Advanced refractory disease
PATIENT CHARACTERISTICS:
No known history of any of the following:
PRIOR CONCURRENT THERAPY:
United States, Washington | |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Recruiting |
Seattle, Washington, United States, 98109-1024 | |
Contact: Clinical Trials Office - Fred Hutchinson Cancer Research Cente 800-804-8824 | |
Tumor Vaccine Group at the University of Washington | Recruiting |
Seattle, Washington, United States, 98109 | |
Contact: Nicole Bates 206-543-6620 |
Principal Investigator: | Lupe G. Salazar, MD | Tumor Vaccine Group at the University of Washington |
Study ID Numbers: | CDR0000489008, UWCC-UW-6193, UWCC-03-9836-D01, FHCRC-6193, FHCRC-UW-6193, FHCRC-119 |
Study First Received: | July 26, 2006 |
Last Updated: | July 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00357448 History of Changes |
Health Authority: | Unspecified |
ovarian clear cell cystadenocarcinoma ovarian mixed epithelial carcinoma ovarian mucinous cystadenocarcinoma ovarian serous cystadenocarcinoma ovarian undifferentiated adenocarcinoma recurrent ovarian epithelial cancer |
stage III ovarian epithelial cancer stage IV ovarian epithelial cancer ovarian endometrioid adenocarcinoma fallopian tube cancer peritoneal cavity cancer |
Cystadenocarcinoma, Serous Fallopian Tube Cancer Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Carcinoma, Endometrioid Genital Diseases, Female Peritoneal Diseases Ovarian Cancer Analgesics Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms Genital Neoplasms, Female Endocrine System Diseases |
Abdominal Neoplasms Ovarian Epithelial Cancer Recurrence Fallopian Tube Neoplasms Carcinoma Digestive System Diseases Analgesics, Non-Narcotic Interleukin-2 Denileukin diftitox Gastrointestinal Neoplasms Peripheral Nervous System Agents Peritoneal Neoplasms Endocrinopathy Adenocarcinoma |
Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms by Site Sensory System Agents Therapeutic Uses Peritoneal Diseases Analgesics Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms Genital Neoplasms, Female |
Endocrine System Diseases Abdominal Neoplasms Fallopian Tube Neoplasms Pharmacologic Actions Adnexal Diseases Fallopian Tube Diseases Neoplasms Digestive System Diseases Interleukin-2 Analgesics, Non-Narcotic Denileukin diftitox Peripheral Nervous System Agents Peritoneal Neoplasms Central Nervous System Agents |