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Belinostat and Azacitidine in Treating Patients With Advanced Hematologic Cancers or Other Diseases

NCT00351975 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2014-12-23

No results posted yet for this study

Summary

This phase I trial is studying the side effects and best dose of belinostat when given together with azacitidine in treating patients with advanced hematologic cancers or other diseases. Belinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving belinostat together with azacitidine may kill more cancer cells.

Conditions

  • Accelerated Phase of Disease
  • Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
  • Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1
  • Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL
  • Adult Acute Promyelocytic Leukemia With t(15;17)(q22;q12); PML-RARA
  • Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
  • Blastic Phase
  • Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Chronic Myelomonocytic Leukemia
  • de Novo Myelodysplastic Syndrome
  • Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
  • Philadelphia Chromosome Negative, BCR-ABL1 Positive Chronic Myelogenous Leukemia
  • Previously Treated Myelodysplastic Syndrome
  • Primary Myelofibrosis
  • Recurrent Adult Acute Lymphoblastic Leukemia
  • Recurrent Adult Acute Myeloid Leukemia
  • Recurrent Disease
  • Secondary Acute Myeloid Leukemia
  • Secondary Myelodysplastic Syndrome

Interventions

DRUG

Belinostat

Given IV

DRUG

Azacitidine

Given SC

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Olatoyosi Odenike · University of Chicago Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States
  • Canada
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00351975 on ClinicalTrials.gov