A Trial of Intravenous Denileukin Diftitox in Stage III or IV Ovarian Cancer (ONTAK)
This study has been completed.
Sponsor:
Tyler Curiel
Information provided by (Responsible Party):
Tyler Curiel, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00880360
First received: April 10, 2009
Last updated: January 7, 2013
Last verified: January 2013
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Purpose
This study tests whether denileukin diftitox will deplete regulatory T cells, boost tumor-specific immunity and treat epithelial ovarian cancer in patients who have failed, or who are ineligible for front line therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Epithelial Ovarian Cancer Extraovarian Peritoneal Cancer Fallopian Tube Carcinoma |
Drug: Ontak |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Intravenous Ontak to Treat Epithelial Ovarian Cancer FIGO Stage III or Stage IV, or Extraovarian Peritoneal Carcinoma, of Fallopian Tube Carcinoma Failing or Ineligible for First-Line Therapy |
Resource links provided by NLM:
Further study details as provided by The University of Texas Health Science Center at San Antonio:
Primary Outcome Measures:
- Number of Participants Demonstrating Clinical Response [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Assess the efficacy of Ontak to treat selected advanced-stage ovarian epithelial cancers measured by clinical response rate, disease-free progression, and overall survival.
Secondary Outcome Measures:
- Toxicity [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Determine any toxicity associated with Ontak treatment in these patients.
| Enrollment: | 19 |
| Study Start Date: | February 2007 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ontak |
Drug: Ontak
Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
Other Name: Denileukin Diftitox
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Able to provide informed consent
- Not on Immune modulating drugs
- Life expectancy less than 6 months
Exclusion Criteria:
- Unable to tolerate phlebotomy
- Germ cell or stromal cell cancers of the ovaries
- Active autoimmune disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880360
Locations
| United States, Texas | |
| CTRC at UTHSCSA | |
| San Antonio, Texas, United States, 78229 | |
Sponsors and Collaborators
Tyler Curiel
Investigators
| Principal Investigator: | Tyler Curiel, MD, PhD | University of Texas Health Science Center at San Antonio |
More Information
No publications provided
| Responsible Party: | Tyler Curiel, Principal Investigator, The University of Texas Health Science Center at San Antonio |
| ClinicalTrials.gov Identifier: | NCT00880360 History of Changes |
| Obsolete Identifiers: | NCT00238186 |
| Other Study ID Numbers: | HSC20070042H, OCR 07-04 |
| Study First Received: | April 10, 2009 |
| Results First Received: | August 13, 2012 |
| Last Updated: | January 7, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by The University of Texas Health Science Center at San Antonio:
|
Epithelial Ovarian Cancer FIGO (International Federation of Gynecology and Obstetrics )Stage III or Stage IV Extraovarian Peritoneal Cancer Fallopian Tube Carcinoma Failing |
Additional relevant MeSH terms:
|
Carcinoma Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases |
Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Denileukin diftitox Interleukin-2 Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013