Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute Leukemia

NCT ID: NCT00008190

Last Updated: 2013-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-03-31
• Study Completion Date: 2008-05-31

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill leukemia cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation and interleukin-2 in treating patients who have acute leukemia.

Detailed Description

OBJECTIVES:

• Determine the efficacy of busulfan, cyclophosphamide, and etoposide followed by autologous peripheral blood stem cell transplantation and interleukin-2 in patients with high-risk acute leukemia.
• Determine the efficacy of immunomodulatory therapies in terms of relapse-free survival of these patients treated with this regimen.
• Determine the hematopoietic reconstitution, relapse, and survival of these patients treated with this regimen.
• Determine the toxicity of this regimen in these patients.

OUTLINE: Following a course of mobilization chemotherapy, patients receive priming therapy comprising filgrastim (G-CSF) and interleukin-2 through the completion of leukapheresis. Patients then receive oral busulfan 4 times daily on days -8 through -5, cyclophosphamide IV continuously on days -4 and -3, and etoposide IV over 2 hours on day -4. For patients unable to receive cyclophosphamide and etoposide, melphalan IV is administered instead on days -3 and -2. Autologous peripheral blood stem cells (PBSC) are reinfused on day 0.

Patients then receive G-CSF daily beginning on day 0 and continuing until blood counts recover followed by interleukin-2 subcutaneously daily beginning at the completion of G-CSF therapy and continuing for 6 months.

Patients are followed weekly for 1 month and then monthly thereafter.

PROJECTED ACCRUAL: A total of 19-25 patients will be accrued for this study within 3-5 years.

Conditions

Leukemia

Study Design

• Primary Study Purpose: TREATMENT

Interventions

aldesleukin

Intervention Type: BIOLOGICAL

filgrastim

Intervention Type: BIOLOGICAL

busulfan

Intervention Type: DRUG

cyclophosphamide

Intervention Type: DRUG

etoposide

Intervention Type: DRUG

melphalan

Intervention Type: DRUG

peripheral blood stem cell transplantation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

PATIENT CHARACTERISTICS:

Age:

• Any age

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• See Disease Characteristics

Hepatic:

• Bilirubin less than 1.5 times normal
• SGOT or SGPT less than 1.5 times normal

Renal:

• Creatinine less than 1.5 times normal

Cardiovascular:

• LVEF at least 45% if receiving cyclophosphamide
• Normal electrocardiogram OR
• Approval by cardiologist

Pulmonary:

• DLCO less than 60% predicted OR
• Approval by pulmonologist

Other:

• Not pregnant or nursing
• No concurrent illness that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Herbert Irving Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Charles S. Hesdorffer, MD

Role: STUDY_CHAIR

Herbert Irving Comprehensive Cancer Center

Locations

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, United States

Countries

United States

Other Identifiers

CPMC-IRB-8872

Identifier Type: -

Identifier Source: secondary_id

CPMC-CAMP-27

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1889

Identifier Type: -

Identifier Source: secondary_id

CDR0000068386

Identifier Type: -

Identifier Source: org_study_id