Gemcitabine and Mitoxantrone in Treating Patients With Relapsed Acute Myeloid Leukemia

NeuroTherapia, Inc.

Status and phase: Terminated; Phase 2

Conditions: Leukemia

Treatments: Drug: Gemcitabine Hydrochloride; Drug: Mitoxantrone Hydrochloride

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00268242

CASE-CCF-7725 (Other Identifier)

P30CA043703 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with mitoxantrone works in treating patients with relapsed acute myeloid leukemia.

Full description

OBJECTIVES:

Primary

• Determine the complete response (CR) rate (CR and incomplete blood count recovery (CRi)) of patients with acute myeloid leukemia in first relapse treated with gemcitabine hydrochloride and mitoxantrone hydrochloride.

Secondary

• Evaluate disease free and overall survival of patients with acute myeloid leukemia in first relapse treated with this particular chemotherapy regimen.
• Assess hematologic and non-hematologic toxicity associated with this regimen.
• Assess laboratory correlates of drug resistance in patients with relapsed acute myeloid leukemia.
• Assess the percentage of patients receiving subsequent bone marrow transplantation.

OUTLINE: This is an open-label, multicenter study.

Patients receive gemcitabine hydrochloride IV over 12 hours on day 1 and mitoxantrone hydrochloride IV over 30-60 minutes on days 1, 2, and 3. After completion of a single course of therapy, patients who achieve a complete response may receive 1 additional course of therapy at the discretion of the treating physician.

After completion of study treatment, patients are followed periodically for survival.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Bone marrow examination or peripheral blood analysis confirming active acute myeloid leukemia by WHO criteria

  • No M3 acute myeloid leukemia

• Not a candidate for allogenic bone marrow transplantation

• Patient must be in first relapse after having received induction chemotherapy

  • Received 1 or 2 courses with remission lasting at least 1 month

• Patients with chloromas or leukemia cutis are eligible

• No evidence of leptomeningeal involvement

PATIENT CHARACTERISTICS:

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

• Liver enzymes (total bilirubin, aspartate aminotransferase (AST) and ALT) ≤ 2.5 times the upper limits of normal

  • Liver enzymes ≥ 2.5 are acceptable if physician documents that it is secondary to the disease

• Serum creatinine ≤ 3 mg/dL

• No poorly controlled medical conditions that would seriously complicate compliance with this study

• No other active primary malignancy other than carcinoma in situ of the cervix or basal cell carcinoma of the skin

• No New York Heart Association grade III or IV cardiac problems, defined as congestive heart failure or myocardial infarction within 6 months prior to start of study

• Pregnant or nursing women are ineligible

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after study participation

• No documented history of human immunodeficiency virus (HIV) infection

• No history of chronic liver disease

• Ejection fraction ≥ 45%

• No significant history of non-compliance to medical regimens or inability to give reliable informed consent

PRIOR CONCURRENT THERAPY:

• Previous treatment related toxicities should be resolved to grade 1 or better
• No other investigational agents within 14 days prior to the start of study
• No chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to start of study
• No major surgery within 2 weeks prior to start of study
• At least two weeks must have elapsed since the conclusion of radiation therapy and the start of gemcitabine hydrochloride, provided the acute effects of radiation treatment have been resolved

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Gemcitabine + Mitoxantrone

Experimental group

Description:

Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m\^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m\^2/day I.V. on days 1, 2, and 3.

Treatment:

Drug: Mitoxantrone Hydrochloride

Drug: Gemcitabine Hydrochloride