Status:
COMPLETED
PKC412, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Acute Myeloid Leukemia (AML)
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
RATIONALE: PKC412 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It may also increase the effectiveness of daunorubicin and cytarabine by making cancer cells m...
Detailed Description
OBJECTIVES: Primary * Determine the safety and tolerability of PKC412 administered sequentially or concurrently with induction chemotherapy comprising daunorubicin and cytarabine followed by consoli...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed acute myeloid leukemia (AML)
- Newly diagnosed disease
- No history of or newly diagnosed myelodysplastic syndromes, history of myeloproliferative disease, or secondary AML
- No CNS malignancy
- PATIENT CHARACTERISTICS:
- Age
- 18 to 60
- Performance status
- Karnofsky 70-100%
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- AST and ALT ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
- No active viral hepatitis
- Renal
- Creatinine ≤ 1.5 times ULN
- No chronic renal disease
- Cardiovascular
- Ejection fraction ≥ 50% by MUGA or echocardiogram
- No congestive heart failure
- No myocardial infarction within the past 6 months
- No poorly controlled hypertension
- No other cardiovascular disease
- Pulmonary
- No pulmonary infiltrate, including those suspected to be infectious
- Patients with pulmonary infection whose clinical symptoms have resolved are eligible provided there are no residual pulmonary infiltrates on chest x-ray
- Other
- No gastrointestinal impairment or disease that would preclude absorption of study drugs
- No uncontrolled diabetes
- No active uncontrolled infection
- No other disease, except carcinoma in situ, that would preclude study participation
- No other severe or uncontrolled medical condition that would preclude study participation
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 3 months after study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- At least 5 days since prior growth factors
- No concurrent biological response modifiers
- Chemotherapy
- No prior chemotherapy
- No other concurrent chemotherapy
- Endocrine therapy
- Not specified
- Radiotherapy
- No prior radiotherapy except radiation castration
- No concurrent radiotherapy
- Surgery
- More than 14 days since prior surgical procedure except central venous catheter placement or other minor procedure (e.g., skin biopsy)
- Other
- More than 30 days since prior investigational agents
- No other concurrent anticancer agents
- No other concurrent investigational drugs
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00093600
Start Date
February 1 2004
End Date
June 1 2011
Last Update
December 19 2020
Active Locations (6)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
2
Dana Faber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-2014
4
MD Anderson Cancer Center/University of Texas
Houston, Texas, United States, 77030