PKC412, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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 more sensitive to the drugs. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining PKC412 with chemotherapy may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best way to give PKC412 when given either after or together with daunorubicin and cytarabine in treating patients with newly diagnosed acute myeloid leukemia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: 4'-N-benzoylstaurosporine; Cytarabine; Daunorubicin; Midostaurin; Staurosporine

Criteria

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