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Study of ABT-751 in Patients With Refractory Hematologic Malignancies

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00047489
Collaborator
(none)
32
Enrollment
1
Location
25
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

ABT-751 is a new antitumor drug that that interferes with cell division. The goal of this clinical research study is to find the highest safe dose of ABT-751 that can be given as a treatment for refractory hematologic malignancies. The safety and side effects of ABT-751 will also be studied.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

The current low cure rates in most patients with advanced hematologic cancers indicate the need to identify new agents that can be incorporated with current therapies to improve prognosis. The vinca alkaloids are effective broad-spectrum anti-leukemic drugs. Microtubules are a major structural component of cells. They play a role in cell shape, cellular polarity, cellular movement, intracellular transport and the segregation of chromosomes during mitosis. The cellular microtubule dynamics are highly regulated. As cells enter mitosis, the interphase microtubules disappear and are replaced with a new network of microtubules that interact with the mitotic spindle. Disruption of these new microtubules leads to cell cycle arrest. These important and highly labile microtubule arrays comprising the mitotic spindle are the principal target of oncologic antimitotic compounds. Known antimitotic agents fall into three classes, the vinca alkaloids (vincristine, vinblastine, and vinorelbine), taxanes (paclitaxel and docetaxel), and colchicine-site binders. There are no colchicine-site agents currently approved for cancer chemotherapy. These three classes of compounds have distinct binding sites on the tubulin subunits. ABT-751 is a novel orally administered antimitotic agent that binds to the colchicine site on beta-tubulin and inhibits polymerization of microtubules.

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Study of ABT-751 in Patients With Refractory Hematologic Malignancies
Study Start Date :
Dec 1, 2002
Actual Primary Completion Date :
Jan 1, 2005
Actual Study Completion Date :
Jan 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    17 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria

    • Patients with relapsed or refractory acute leukemias (AML, ALL, MDS [RAEB, RAEBT], CMML in transformation with >/= 10% peripheral blood/bone marrow blasts, CML in blast crisis), and patients with relapsed/refractory or transformed CLL.

    • Signed informed consent indicating that patients are aware of the investigational nature of this study, and in keeping with the policies of this hospital.

    • ECOG performance status </= 2.

    • Serum direct bilirubin </= 2 mg/dL, serum SGOT or SGPT < 3 upper limit of normal, serum creatinine </= 2 mg/dL, unless considered due to organ leukemic involvement.

    • Age > 16 years - a separate Phase I study is being conducted in the pediatric population.

    Exclusion Criteria

    • Any severe, concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for study entry.

    • Pregnant and/or lactating females.

    • Those with documented sulfonamide allergy should be excluded from study participation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Texas M.D. Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: Francis J. Giles, MD, UT MD Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00047489
    Other Study ID Numbers:
    • DM01-646
    First Posted:
    Oct 9, 2002
    Last Update Posted:
    Oct 31, 2018
    Last Verified:
    Oct 1, 2018
    Additional relevant MeSH terms:
    Neoplasms
    Hematologic Neoplasms

    Study Results

    No Results Posted as of Oct 31, 2018