A Phase I Study of Intravenous DX-8951f in Patients With Advanced Myelodysplastic Syndromes, Refractory Acute Leukemia, Refractory or Transformed Chronic Lymphocytic Leukemia, and Chronic Myelogenous Leukemia in Blastic Phase


Phase 1
N/A
N/A
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes

Thank you

Trial Information

A Phase I Study of Intravenous DX-8951f in Patients With Advanced Myelodysplastic Syndromes, Refractory Acute Leukemia, Refractory or Transformed Chronic Lymphocytic Leukemia, and Chronic Myelogenous Leukemia in Blastic Phase


OBJECTIVES: I. Determine the maximum tolerated dose of DX-8951f in patients with advanced
myelodysplastic syndromes, refractory acute myeloid or lymphocytic leukemia, refractory or
transformed chronic lymphocytic leukemia, or chronic myelogenous leukemia in blastic phase.
II. Evaluate the quantitative and qualitative toxic effects of this regimen and determine
the duration and reversibility of these effects in these patients. III. Make a preliminary
determination of the antileukemic activity of this regimen in these patients. IV. Evaluate
the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a dose escalation study. Patients receive DX-8951f IV over 30 minutes daily
for 5 days. Treatment continues every 3 weeks for at least 2 courses in the absence of
disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating
doses of DX-8951f until the maximum tolerated dose (MTD) is determined. The MTD is defined
as the dose preceding that at which at least 2 of 6 patients experience dose limiting
toxicity. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: Approximately 20-25 evaluable patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: One of the following hematologic malignancies: Advanced
myelodysplastic syndromes Refractory anemia with excess blasts Refractory anemia with
excess blasts in transformation Chronic myelomonocytic leukemia Refractory acute myeloid
leukemia (AML) First salvage with primary refractory AML or first complete response (CR)
no greater than 12 months in duration or at least second salvage therapy Once maximum
tolerated dose is determined, intermediate AML prognosis (first CR duration greater than
12 months but less than 24 months) eligible Refractory acute lymphocytic leukemia
Refractory or transformed chronic lymphocytic leukemia Chronic myelogenous leukemia in
blastic phase No CNS disease

PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: No specified Hepatic: Bilirubin no greater than 2.0 mg/dL
SGOT or SGPT no greater than 2.0 times upper limit of normal Renal: Creatinine no greater
than 2.0 mg/dL Cardiovascular: No active congestive heart failure No uncontrolled angina
No myocardial infarction within the past 6 months Other: Not pregnant or nursing Fertile
patients must use effective contraception Negative pregnancy test No concurrent grade 4
infection No psychiatric disorder or mental disability No other life threatening illness

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy:
At least 30 days since prior cytotoxic therapy and recovered No concurrent chemotherapy
Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy to greater than
25% of skeleton Surgery: No concurrent surgery Other: At least 3 weeks since prior
investigational drugs (including analgesics or antiemetics) Recovered from toxic effects
of any prior therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert L. DeJager, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Daiichi Sankyo Inc.

Authority:

United States: Federal Government

Study ID:

CDR0000067149

NCT ID:

NCT00004047

Start Date:

June 1999

Completion Date:

April 2005

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • relapsing chronic myelogenous leukemia
  • refractory chronic lymphocytic leukemia
  • blastic phase chronic myelogenous leukemia
  • refractory anemia with excess blasts
  • refractory anemia with excess blasts in transformation
  • chronic myelomonocytic leukemia
  • childhood myelodysplastic syndromes
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009