NCI 8977: Phase 2 Trial of R11577 in Previously Untreated Older Adults with AML and Baseline Presence of a Specific 2-Gene Expression Signature Ratio
Study Status
Open to Enrollment
Study Description
The purpose of this study is to determine the ability of a new test to predict whether patients with acute myeloid leukemia (AML) will benefit from treatment with the drug R115777 (ZARNESTRA).
Scientific experiments have suggested that R115777 can inhibit the function of proteins that play a role in the development of leukemia. Clinical studies of R115777 in humans have demonstrated that the drug can induce complete remissions (CR) in approximately 8-20% of patients with AML. R115777 is an experimental anticancer agent that has not yet been approved by the Food and Drug Administration for use in acute myeloid leukemia.
There is currently no method available to identify patients who are more likely to benefit from R115777 prior to treating them. This study will test the ability of a newly developed screening test to identify patients who are more likely to benefit from R115777 therapy.
RASGRP1 and APTX are genes that are expressed in leukemia cells. This test is performed on a sample of bone marrow tissue, and determines the ratio of RASGRP1 and APTX expression in the bone marrow. Ratios that are ≥5 are will be considered as a positive result, and these patients will be eligible for treatment with R115777. The ratio of ≥5 is expected to be found in about 30% of patients. This screening test is still considered an experimental procedure.
You will be asked to take R115777 for a maximum of six cycles (a maximum of six months of therapy), or until your physician feels you are no longer benefitting from the therapy. After you are finished taking R115777, the study doctor will ask you to visit the office for follow-up exams for at least 30 days after your last dose, or until you begin a new therapy. In addition, your physician or other study staff members may contact you periodically by phone to inquire about your condition, and any additional therapies you have taken.
Disease Status and/or Stage
Acute Myeloid Leukemia
Sponsor
National Cancer Institute
Key Eligibility
- Men and women age 65 or older
- Diagnosed with AML (de novo or secondary)
- No prior treatment
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- Tania Curcio, RN
- (212) 746-2571
- tjc9003@med.cornell.edu
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
roh2026@med.cornell.edu
