Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy in Treating Patients With Recurrent or Refractory Leukemia or Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	55 and under	NCI	CWRU-5Y01 NCI-G02-2113, CWRU-11021P, NCT00047021, CASE-5Y01

Objectives

1. Determine non-hematologic toxic effects of high-dose cytarabine and high-dose mitoxantrone in patients with recurrent or refractory leukemia or lymphoma.
2. Determine the in vitro T/NK lymphocyte proliferative responses to patient's leukemia/lymphoma cells before and after treatment with this regimen.

Entry 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

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

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/mm³*
  • Platelet count at least 20,000/mm³*

 [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

Expected Enrollment

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

Outcomes

Event free survival at day 14 (myeloid engraftment)

Incidence of serious infections by clinical, radiologic, microbiology assessment during and after treatment

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.

Trial Contact Information

Trial Lead Organizations

Ireland Cancer Center at University Hospitals/Case Medical Center

Mary Laughlin, MD, Protocol chair		Ph: 216-368-5693 Email: mjl13@po.cwru.edu

Registry Information
Official Title		A Pilot Study Of Cytarabine And High-Dose Mitoxantrone For Relapsed Or Refractory Hematologic Malignancies
Trial Start Date		2001-11-30
Registered in ClinicalTrials.gov		NCT00047021
Date Submitted to PDQ		2002-08-08
Information Last Verified		2006-01-18
NCI Grant/Contract Number		P30-CA43703

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