Irinotecan and Cytarabine in Treating Patients With Refractory or Recurrent Acute Myeloid Leukemia or Chronic Myelogenous Leukemia - Full Text View

Sponsor:	Roswell Park Cancer Institute
Collaborator:	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

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

Resource links provided by NLM:

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

Drug Information available for: Cytarabine hydrochloride Irinotecan U 101440E Irinotecan hydrochloride Cytarabine

U.S. FDA Resources

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

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000269286, RPCI-RPC-9901
Study First Received:	January 27, 2003
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00053144 History of Changes
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)

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Irinotecan
Physiological Effects of Drugs
Leukemia, Myeloid, Acute
Leukemia
Therapeutic Uses
Cytarabine
Neoplasms by Histologic Type

Hematologic Diseases
Myeloproliferative Disorders
Enzyme Inhibitors
Leukemia, Myeloid
Antiviral Agents
Immunosuppressive Agents
Camptothecin
Pharmacologic Actions
Neoplasms
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Bone Marrow Diseases
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 27, 2009