Imatinib Mesylate, Daunorubicin, and Cytarabine in Treating Patients With Relapsed Acute Myeloid Leukemia

NCT00268229 | Completed Phase 1

• 2 other identifiers: CASE-CCF-6441P30CA043703
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving imatinib mesylate together with daunorubicin and cytarabine may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate when given together with daunorubicin and cytarabine in treating patients with relapsed acute myeloid leukemia.

Conditions

Leukemia

Keywords

recurrent adult acute myeloid leukemia; adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); adult acute minimally differentiated myeloid leukemia (M0); adult acute megakaryoblastic leukemia (M7); adult acute monoblastic leukemia (M5a); adult acute monocytic leukemia (M5b); adult acute myeloblastic leukemia with maturation (M2); adult acute myeloblastic leukemia without maturation (M1); adult acute myelomonocytic leukemia (M4); adult erythroleukemia (M6a); adult pure erythroid leukemia (M6b)

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose of imatinib mesylate at one year

  1 year

Secondary Outcomes (1)

• Non-dose limiting toxicities associated with imatinib mesylate at one year

  1 year

Interventions

cytarabine DRUG

300 mg/m2/day

daunorubicin hydrochloride DRUG

45 mg/m2/day

imatinib mesylate DRUG

dose escalation (300 mg/day to 800 mg/day).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Bone marrow biopsy confirming acute myeloid leukemia (AML) * No M3 AML * Patient must have relapsed to standard chemotherapy * Patients who relapse within six months of response to treatment or those who never responded to an anthracycline/cytarabine combination will be excluded * At least 20% of peripheral blood or bone marrow blasts positive for c-kit * No evidence of leptomeningeal involvement PATIENT CHARACTERISTICS: * ECOG Performance Status 0-2 * Liver enzymes (AST and ALT) and total bilirubin ≤ 2 times upper limit of normal * Serum creatinine ≤ 2 times upper limit of normal * No New York Heart Association grade III or IV cardiac problems * Defined as congestive heart failure or myocardial infraction within the past 6 months * No known chronic liver disease (i.e., chronic active hepatitis and cirrhosis) * No serious or poorly controlled medical conditions that could be exacerbated by the treatment or would seriously complicate compliance with this study * No other active primary malignancy unless it is not currently clinically significant and does not require active intervention * No history of HIV infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * No significant history of noncompliance to medical regimens or inability to grant reliable informed consent PRIOR CONCURRENT THERAPY: * Previous treatment-related toxicities should be resolved * No other investigational agents within the past 28 days * No chemotherapy within the past 4 weeks * 6 weeks for nitrosourea or mitomycin C * No major surgery within the past 4 weeks * No concurrent use of the following drugs is allowed: ketoconazole, dilantin, itraconazole, erythromycin, clarithromycin, dexamethasone, rifampin, tegretol, phenobarbital, Hypericum perforatum (St. John's wort), cyclosporine, pimozide, warfarin, certain HMG-CoA reductase inhibitors, traizolo-benzodiazepines, or dihydropyridine calcium channel blockers * No other concurrent anticancer agents, including chemotherapy and biologic agents * No other concurrent investigational drugs * Concurrent medications known to be metabolized by cytochrome p450 enzymes are allowed * No therapeutic anticoagulation with warfarin will be permitted in patients participating in this study * Therapeutic anticoagulation may be accomplished using low-molecular weight heparin * Mini-dose warfarin for prophylaxis of central venous catheter thrombosis allowed * No concurrent routine use of systemic corticosteroid therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute; Congenital Abnormalities; Leukemia, Megakaryoblastic, Acute; Leukemia, Monocytic, Acute; Leukemia, Myelomonocytic, Acute; Leukemia, Erythroblastic, Acute

Interventions

Cytarabine; Daunorubicin; Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Myeloproliferative Disorders; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Piperazines

Study Officials

• Anjali Advani, MD

  The Cleveland Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2005
• First Posted: December 22, 2005
• Study Start: July 1, 2003
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

US (1)