NCT00008190

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

High Dose Chemotherapy And Autologous Peripheral Blood Stem Cell Rescue For High Risk Acute Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Herbert Irving Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	aldesleukin
BIOLOGICAL	filgrastim
DRUG	busulfan
DRUG	cyclophosphamide
DRUG	etoposide
DRUG	melphalan
PROCEDURE	peripheral blood stem cell transplantation

Timeline

• Start date: 1999-03-01
• Primary completion: 2005-11-01
• Completion: 2008-05-01
• First posted: 2003-01-27
• Last updated: 2013-02-04

Locations

1 site across 1 country: United States