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Irinotecan and Cytarabine in Treating Patients With Refractory or Recurrent Acute Myeloid Leukemia or Chronic Myelogenous Leukemia

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Roswell Park Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00053144
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of combining irinotecan with cytarabine in treating patients who have refractory or recurrent acute myeloid leukemia or chronic myelogenous leukemia.


Condition Intervention Phase
Leukemia
Drug: cytarabine
Drug: irinotecan hydrochloride
Phase I

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood   

ChemIDplus related topics:   Cytarabine    Cytarabine hydrochloride    Irinotecan    Irinotecan hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Irinotecan And Cytarabine In Refractory or Relapsed Acute Myeloid Leukemia And In Chronic Myelogenous Leukemia In Myeloid Blast Transformation: Efficacy And In Vitro Correlates

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   November 1999

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053144

Locations
United States, New York
Roswell Park Cancer Institute    
      Buffalo, New York, United States, 14263-0001

Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)

Investigators
Study Chair:     Maria R. Baer, MD     Roswell Park Cancer Institute    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000269286, RPCI-RPC-9901
First Received:   January 27, 2003
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00053144
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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)

Study placed in the following topic categories:
Philadelphia Chromosome
Leukemia, Monocytic, Acute
Blast Crisis
Chronic myelogenous leukemia
Irinotecan
Acute myelomonocytic leukemia
Leukemia, Myeloid, Acute
Di Guglielmo's syndrome
Leukemia
Leukemia, Promyelocytic, Acute
Neoplasm Metastasis
Acute erythroblastic leukemia
Acute myeloid leukemia, adult
Acute myelocytic leukemia
Cytarabine
Hematologic Diseases
Myeloproliferative Disorders
Acute myelogenous leukemia
Acute promyelocytic leukemia
Leukemia, Myeloid
Camptothecin
Recurrence
Leukemia, Myelomonocytic, Acute
Leukemia, Erythroblastic, Acute
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Bone Marrow Diseases
Acute monoblastic leukemia

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 05, 2008




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