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

• Status: Completed
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Camptothecin; Cytarabine; Irinotecan

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