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A Study to Evaluate PT-523 in Patients With Refractory Leukemia

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00129558
First received: August 10, 2005
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

This Phase I/II, multi-centered, non-randomized, trial is designed to determine a safe dose of PT-523 for subjects, and to make preliminary evaluations on the activity of PT-523 as therapy in subjects with refractory leukemia.


Condition Intervention Phase
Leukemia
Drug: PT-523 for Injection
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of PT-523 in Patients With Refractory Leukemia

Resource links provided by NLM:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Enrollment: 0
Study Start Date: July 2005
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Relapsed/refractory leukemias including acute non-lymphocytic leukemia (AML), acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), and chronic myelogenous leukemia in blastic phase (CML-BP) for which no standard therapies are anticipated to result in a durable remission; or poor-risk myelodysplasia (MDS) patients to include refractory anemia with excess blasts (RAEB) or excess blasts in transformation (RAEBT) and chronic myelomonocytic leukemia (CMML) who are either relapsed/refractory or who refuse/are not eligible for frontline therapy.
  • Only patients with refractory ALL or CML in lymphoid blastic phase are eligible for phase II.
  • ECOG performance status 0 - 2.
  • Adequate organ function and bone marrow reserve.
  • At least 4 weeks must have elapsed from the time of major surgery.
  • Use of appropriate contraceptive method.
  • Signed patient informed consent.

Exclusion Criteria:

  • Known human immunodeficiency virus (HIV).
  • Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure.
  • Patients receiving any other standard or investigational treatment for their leukemia other than corticosteriods, hydroxyurea, and 6-mercaptopurine.
  • Any medical condition which, in the opinion of the investigator, places the patient at an unacceptably high risk for toxicities.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129558

Locations
United States, California
UCLA School of Medicine
Los Angeles, California, United States, 90095-3075
USC, Kennth Norris Jr. Comprehensive Cancer Center
Los Angeles, California, United States, 90033-1048
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest University School of Medicine Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1082
United States, Texas
University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00129558     History of Changes
Other Study ID Numbers: HBS103
Study First Received: August 10, 2005
Last Updated: December 2, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 24, 2014