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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2005-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Leukemia Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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sargramostim

Sargramostim (GM-CSF) subcutaneously beginning on day 14 and continuing until blood counts recover.

Intervention Type BIOLOGICAL

cytarabine

high-dose cytarabine IV over 1 hour on days 1-5

Intervention Type DRUG

mitoxantrone hydrochloride

high-dose mitoxantrone IV over 15-30 minutes on day 5.

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No