Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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 II trial to study the effectiveness of combining cytarabine and mitoxantrone in treating patients who have recurrent or refractory leukemia or lymphoma.

Further Study Information

OBJECTIVES:

• Determine non-hematologic toxic effects of high-dose cytarabine and high-dose mitoxantrone in patients with recurrent or refractory leukemia or lymphoma.

• Determine the in vitro T/NK lymphocyte proliferative responses to patient's leukemia/lymphoma cells before and after treatment with this regimen.

OUTLINE: Patients receive high-dose cytarabine IV over 1 hour on days 1-5 and high-dose mitoxantrone IV over 15-30 minutes on day 5. Patients also receive sargramostim (GM-CSF) subcutaneously beginning on day 14 and continuing until blood counts recover.

Patients who achieve at least stable disease or a response may receive a second course beginning at least 14 days after the first course is completed.

Patients are followed for 3 months.

PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within approximately 2-3 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• One of the following must be present:

• Histologically confirmed acute myeloid leukemia or acute lymphoblastic leukemia

• More than 5% blasts in the bone marrow or peripheral blood unrelated to recovery of normal hematopoiesis from prior chemotherapy

• Failed at least 1 attempt at induction chemotherapy

• Diagnosis of non-Hodgkin's lymphoma or Hodgkin's lymphoma

• Refractory or relapsed after at least 1 regimen of standard chemotherapy

• Diagnosis of chronic myelogenous leukemia in accelerated phase or blast crisis

• Received at least 1 myelotoxic chemotherapy regimen

• Active CNS involvement allowed

PATIENT CHARACTERISTICS:

Age

• 55 and under

Performance status

• ECOG 0-2

Life expectancy

• At least 5 weeks

Hematopoietic

• Lymphoma patients:

• WBC at least 2,000/mm^3*

• Platelet count at least 20,000/mm^3* NOTE: *Unless due to bone marrow involvement or disease process

Hepatic

• Bilirubin no greater than 3 times normal*

• AST/ALT no greater than 3 times normal*

• Alkaline phosphatase no greater than 3 times normal*

• No severe liver failure NOTE: *Unless related to leukemia

Renal

• Creatinine clearance greater than 50 mL/min

• No severe renal failure

Cardiovascular

• LVEF at least 45% by MUGA

Pulmonary

• DLCO at least 60% of predicted

Other

• HIV negative

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No psychiatric illness that would preclude informed consent

• No medical illness or other condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

• At least 24 hours since prior hydroxyurea

• At least 1 week since other prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• Recovered from prior therapy

Trial Contact Information

Trial Lead Organizations/Sponsors

Case Comprehensive Cancer Center

Mary J. Laughlin, MD

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00047021
Information obtained from ClinicalTrials.gov on December 14, 2011

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