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

Lymphoma Clinical Trial

Official title:

A Pilot Study Of Cytarabine And High-Dose Mitoxantrone For Relapsed Or Refractory Hematologic Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00047021
• Other study ID #: CWRU5Y01
• Secondary ID: P30CA043703CWRU-
• Status: Completed
• Phase: Phase 2
• First received: October 3, 2002
• Last updated: June 10, 2010
• Start date: November 2001
• Est. completion date: September 2005

Study information

• Verified date: June 2010
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: September 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 55 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Lymphoma

Intervention

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

Drug:
• cytarabine
high-dose cytarabine IV over 1 hour on days 1-5
• mitoxantrone hydrochloride
high-dose mitoxantrone IV over 15-30 minutes on day 5.

Locations

Country	Name	City	State
United States	Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event free survival at day 14 (myeloid engraftment)		day 14	No
Secondary	Incidence of serious infections by clinical, radiologic, microbiology assessment during and after treatment		followed for 3 months	No