Flavopiridol and Imatinib Mesylate in Treating Patients With Hematologic Cancer

NCT00064285 | Completed Phase 1

• 6 other identifiers: CDR0000310175U01CA062502MCV-NCI-6013MCV-VCU-1902NCI-6013CWRU-030323
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 4

Brief Summary

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy such as flavopiridol use different ways to stop cancer cells from dividing so they stop growing or die. Combining imatinib mesylate with flavopiridol may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of flavopiridol and imatinib mesylate in treating patients with hematologic cancer.

Conditions

Leukemia

Keywords

chronic phase chronic myelogenous leukemia; blastic phase chronic myelogenous leukemia; accelerated phase chronic myelogenous leukemia; recurrent adult acute myeloid leukemia; untreated adult acute myeloid leukemia; adult acute myeloid leukemia in remission; adult acute lymphoblastic leukemia in remission; recurrent adult acute lymphoblastic leukemia; untreated adult acute lymphoblastic leukemia; relapsing chronic myelogenous leukemia; adult acute myeloid leukemia with t(8;21)(q22;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with t(15;17)(q22;q12)

Interventions

alvocidib DRUG

imatinib mesylate DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Chronic or accelerated phase chronic myelogenous leukemia (CML) with 1 of the following: * Hematologic progression during prior imatinib mesylate treatment * Less than a complete hematologic response after at least 3 months of prior imatinib mesylate treatment * Less than a major cytogenetic response after at least 6 months of imatinib mesylate treatment (cytogenetic response documented by karyotype or fluorescence in situ hybridization \[FISH\]) * Blastic phase CML\* * Acute lymphoblastic leukemia\* * Acute myeloid leukemia\* NOTE: \*Patients may be enrolled at presentation, in remission, or upon relapse * Bcr/Abl+ in bone marrow confirmed by karyotype or FISH * No known CNS malignancy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST and ALT no greater than 2.5 times ULN (5 times ULN if hepatic involvement suspected \[stratum 2 only\]) Renal * Creatinine no greater than 2 times ULN Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Not pregnant or nursing * Fertile patients must use effective contraception during and for 3 months after study participation * No prior allergic reaction attributed to compounds of similar chemical or biological composition to study agents * No other concurrent uncontrolled medical illness * No ongoing or active infection * No psychiatric illness or social situation that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or interleukin-2 during the first course of study therapy unless clinically indicated for management of febrile neutropenia or thrombocytopenia * Concurrent epoetin alfa allowed if started before study entry and it remains clinically appropriate Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * See Disease Characteristics * Recovered from all prior therapy * No other concurrent investigational or anticancer agents * No concurrent combination antiretroviral therapy for HIV-positive patients

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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University

Cleveland, Ohio, 44106-5047, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Massey Cancer Center at Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Chronic-Phase; Blast Crisis; Leukemia, Myeloid, Accelerated Phase; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Congenital Abnormalities

Interventions

alvocidib; Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Steven Grant, MD

  Massey Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 8, 2003
• First Posted: July 9, 2003
• Study Start: June 1, 2003
• Last Updated: May 3, 2010

Record last verified: 2010-04

Locations

US (4)