NCT00053144

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 1999

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1999

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2003

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2003

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
Last Updated

March 8, 2011

Status Verified

March 1, 2011

Enrollment Period

3.3 years

First QC Date

January 27, 2003

Last Update Submit

March 7, 2011

Conditions

Leukemia

Keywords

recurrent adult acute myeloid leukemiaPhiladelphia chromosome positive chronic myelogenous leukemiasecondary acute myeloid leukemiablastic phase chronic myelogenous leukemiarelapsing chronic myelogenous leukemiaadult 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)

Interventions

cytarabineDRUG
irinotecan hydrochlorideDRUG

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, AcuteLeukemia, Myelogenous, Chronic, BCR-ABL PositiveBlast CrisisLeukemia, Monocytic, AcuteLeukemia, Erythroblastic, AcuteLeukemia, Megakaryoblastic, AcuteLeukemia, Myelomonocytic, AcuteLeukemia, Promyelocytic, Acute

Interventions

CytarabineIrinotecan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic Processes

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCamptothecinAlkaloids

Study Officials

  • Maria R. Baer, MD

    Roswell Park Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 27, 2003

First Posted

January 28, 2003

Study Start

November 1, 1999

Primary Completion

February 1, 2003

Study Completion

March 1, 2003

Last Updated

March 8, 2011

Record last verified: 2011-03

Locations

US(1)