Status:
TERMINATED
Gene Expression During Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Treated With Choline Magnesium Trisalicylate
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in cancer cells. It may also help doctors understand how cancer ce...
Detailed Description
OBJECTIVES: Primary * Determine temporal changes in leukemic cell NF-kB activity when choline magnesium trisalicylate is administered during induction chemotherapy in patients with newly diagnosed a...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed acute myeloid leukemia
- Newly diagnosed disease
- Presence of cytogenetic abnormalities must be determined by standard cytogenetics with or without FISH studies
- Leukemic blast count \> 5,000/mm³ of peripheral blood
- No acute promyelocytic leukemia (M3)
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-3
- Bilirubin \< 2.0 times upper limit of normal (ULN)
- AST \< 3.0 times ULN
- Creatinine \< 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled psychiatric illness that, in the opinion of the principal investigator, would preclude study compliance
- No other concurrent medical condition that would preclude study compliance
- No allergies to any investigational drugs and/or chemotherapeutic agents
- No upper or lower gastrointestinal (GI) related hemorrhage within the past 6 months as determined by endoscopy
- No clinical diagnosis of GI bleeding requiring blood transfusions
- PRIOR CONCURRENT THERAPY:
- No prior induction therapy
- No prior chemotherapy for acute leukemia
- No concurrent medications that would preclude study compliance
Exclusion
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00156299
Start Date
March 1 2003
End Date
July 1 2008
Last Update
November 19 2013
Active Locations (1)
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1
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903