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Irinotecan And Cytarabine In Refractory or Relapsed Acute Myeloid Leukemia And In Chronic Myelogenous Leukemia In Myeloid Blast Transformation: Efficacy And In Vitro Correlates


Phase 1
15 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

Irinotecan And Cytarabine In Refractory or Relapsed Acute Myeloid Leukemia And In Chronic Myelogenous Leukemia In Myeloid Blast Transformation: Efficacy And In Vitro Correlates


OBJECTIVES:

- Determine the activity of irinotecan and cytarabine in patients with refractory or
recurrent acute myeloid leukemia or chronic myelogenous leukemia in myeloid blast
transformation.

- Determine the pharmacokinetics of this regimen in these patients.

- Determine the maximum tolerated dose of irinotecan in this regimen in these patients.

- Correlate the clinical activity of this drug with cellular endpoints associated with
DNA synthesis inhibition, DNA repair, induction of apoptosis, and drug resistance in
these patients.

OUTLINE: This is a dose-escalation study of irinotecan.

Patients receive irinotecan IV over 90 minutes and cytarabine IV over 60 minutes on days
1-6. Courses repeat every 4 weeks in the absence of disease progression or unacceptable
toxicity.

Cohorts of 3-6 patients receive escalating doses of irinotecan 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. An additional 9 patients with
refractory/relapsed acute myeloid leukemia and 9 patients with chronic myelogenous leukemia
in myeloid blast transformation are treated at the MTD.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 2.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed acute myeloid leukemia (M0-M7)

- De novo or secondary disease

- Previously treated and refractory to prior therapy (which has included
high-dose cytarabine and an anthracycline)

- Antecedent hematologic disorders allowed OR

- Histologically confirmed Philadelphia chromosome-positive chronic myelogenous
leukemia in myeloid blast transformation

- Treated or untreated

- Blast transformation defined by at least 20% blasts in marrow and/or blood

- Myeloid lineage defined by immunophenotyping

PATIENT CHARACTERISTICS:

Age

- 15 and over

Performance status

- 0-3

Life expectancy

- At least 4 weeks

Hematopoietic

- See Disease Characteristics

Hepatic

- Bilirubin less than 2 times upper limit of normal (ULN)

- SGOT less than 2 times ULN

Renal

- Creatinine less than 1.5 times ULN

Other

- Not pregnant or nursing

- Negative pregnancy test

- No other concurrent serious medical or psychiatric illness that would preclude study
consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

- Prior chemotherapy for an antecedent malignancy or other medical condition allowed

Endocrine therapy

- Not specified

Radiotherapy

- Prior radiotherapy for an antecedent malignancy or other medical condition allowed

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Maria R. Baer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000269286

NCT ID:

NCT00053144

Start Date:

November 1999

Completion Date:

March 2003

Related Keywords:

  • Leukemia
  • recurrent adult acute myeloid leukemia
  • Philadelphia chromosome positive chronic myelogenous leukemia
  • secondary acute myeloid leukemia
  • blastic phase chronic myelogenous leukemia
  • relapsing chronic myelogenous leukemia
  • adult acute monocytic leukemia (M5b)
  • adult acute erythroid leukemia (M6)
  • adult acute megakaryoblastic leukemia (M7)
  • adult acute minimally differentiated myeloid leukemia (M0)
  • adult acute myeloblastic leukemia with maturation (M2)
  • adult acute myeloblastic leukemia without maturation (M1)
  • adult acute myelomonocytic leukemia (M4)
  • adult acute monoblastic leukemia (M5a)
  • adult acute promyelocytic leukemia (M3)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263