Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia

• Status: Completed
• Trial end date: 2006-04-01
• 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 combination chemotherapy with carboplatin and topotecan in treating patients with chronic myelogenous leukemia or recurrent acute leukemia.

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

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Topotecan

Criteria

DISEASE CHARACTERISTICS:

• Acute lymphocytic or myeloid leukemia (ALL or AML) in 1 of the following categories:

• Failed to achieve a complete response (CR) with initial induction regimen

• First relapse within 1 year of initial CR

• Failed re-induction therapy at first relapse

• Second relapse after no more than 2 different induction regimens

• Relapse defined as more than 10% blasts in marrow or circulating blasts in peripheral blood and either:

• Symptoms of recurrence (e.g., B symptoms)

• Evidence of impending marrow failure (i.e., cytopenias) OR

• Chronic myelogenous leukemia in accelerated or blastic phase after no more than 1 prior induction regimen

• No HLA-identical sibling marrow donor or patient ineligible for allogeneic marrow transplantation

• No clinical symptoms of CNS leukemia

• Patients with history of CNS leukemia must have pretreatment lumbar puncture demonstrating absence of active CNS disease

• No active CNS disease

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 4 weeks

Hematologic:

• Not applicable

Hepatic:

• Bilirubin less than 2 mg/dL

Renal:

• Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• No congestive heart failure

• No poorly controlled arrhythmia

• No myocardial infarction within the past 3 months

Other:

• No active infection

• No other serious medical condition that would prevent compliance

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

Chemotherapy:

• See Disease Characteristics

• At least 24 hours since prior hydroxyurea for impending leukostasis

• No concurrent hydroxyurea glucocorticoids

• Recovered from prior chemotherapy

Endocrine therapy:

• At least 24 hours since prior glucocorticoids for impending leukostasis

• At least 7 days since prior amphotericin or aminoglycosides

• No concurrent glucocorticoids

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No concurrent aminoglycoside antibiotics