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Sponsored by: |
University of Pennsylvania |
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Information provided by: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT00615784 |
The purpose of this study is to evaluate the activity of bexarotene, a retinoic acid class drug, in patients with Acute Myeloid Leukemia (AML) that has returned after or is resistant to standard chemotherapy or are otherwise not eligible for conventional chemotherapy. Retinoic acids are a class of drugs related to Vitamin A, and have a wide range of effects within normal and malignant cells that affect cell growth and cell death.
Condition | Intervention | Phase |
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Acute Myeloid Leukemia |
Drug: Bexarotene |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | A Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia |
Estimated Enrollment: | 17 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: Bexarotene
Bexarotene given orally at a dose of 300mg/m2 until disease progression or unacceptable toxicities experienced by patient
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Melissa Potuzak | 215-662-7383 | melissa.potuzak@uphs.upenn.edu |
United States, Pennsylvania | |
Abramson Cancer Center of University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Melissa Potuzak 215-662-7383 melissa.potuzak@uphs.upenn.edu |
Principal Investigator: | Donald E. Tsai, MD, PhD | University of Pennsylvania |
Responsible Party: | University of Pennsylvania ( Donald Tsai, M.D. ) |
Study ID Numbers: | UPCC 04407, UPCC 04407 |
Study First Received: | February 1, 2008 |
Last Updated: | February 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00615784 |
Health Authority: | United States: Institutional Review Board |
Acute Myeloid Leukemia AML Bexarotene |
Leukemia Bexarotene Acute myelogenous leukemia |
Leukemia, Myeloid Leukemia, Myeloid, Acute Acute myelocytic leukemia |
Anticarcinogenic Agents Neoplasms Neoplasms by Histologic Type Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Protective Agents Pharmacologic Actions |