High-Dose Chemotherapy and Radiation Therapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Acute Leukemia in Remission

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00002567

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

80.1

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

PURPOSE: Phase II trial to study the effectiveness of high-dose radiation therapy and etoposide followed by peripheral stem cell transplantation in treating patients with acute leukemia.

Condition or Disease	Intervention/Treatment	Phase
Bone Marrow Ablation Leukemia	Biological: filgrastim Drug: etoposide Procedure: peripheral blood stem cell transplantation Radiation: low-LET electron therapy Radiation: low-LET photon therapy	Phase 2

Detailed Description

OBJECTIVES: I. Evaluate the efficacy of myeloablative total-body irradiation and etoposide followed by autologous peripheral blood stem cell (PBSC) transplantation in prolonging the disease-free survival of patients with acute leukemia. II. Investigate the ability of growth factor-primed PBSC to provide hematopoietic reconstitution following myeloablative therapy.

OUTLINE: Patients are treated on Regimen A, then Regimen B. Regimen A: Stem Cell

Mobilization. Granulocyte Colony Stimulating Factor (Amgen), G-CSF, NSC-614629. Regimen B:

Radiotherapy and Myeloablative Chemotherapy with Hematopoietic Rescue. Total-Body Irradiation, TBI (high-energy electrons used for lung boost); and Etoposide, VP-16, NSC-141540; with Peripheral Blood Stem Cells, PBSC; G-CSF.

PROJECTED ACCRUAL: Up to 45 patients will be studied over approximately 3 years.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Primary Purpose:

Treatment

Official Title:

PHASE II STUDY EVALUATING AUTOLOGOUS PERIPHERAL BLOOD PROGENITOR CELL TRANSPLANTATION FOR ACUTE LEUKEMIAS

Study Start Date :

Mar 1, 1994

Actual Primary Completion Date :

Nov 1, 2000

Actual Study Completion Date :

Nov 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS: Previously diagnosed acute leukemia in one of the following categories: Acute myelogenous leukemia (any subtype) in first or subsequent remission Ph+ acute lymphoblastic leukemia (ALL) in first or greater remission Ph- ALL in second or subsequent remission Cellular marrow with no morphologic evidence of residual leukemia within approximately 2 weeks of cryopreservation Negative CSF cytology required of ALL patients Allogeneic marrow transplant considered for patients under age 55 with a healthy HLA-identical family member available

PATIENT CHARACTERISTICS: Age: Over 16 to 65 Performance status: Not specified

Hematopoietic: WBC greater than 3,500/mm3 Platelet count greater than 100,000/mm3 Hepatic:

Bilirubin less than 2.0 mg/dl Renal: Creatinine no greater than 1.5 mg/dl OR Creatinine clearance at least 60 ml/min Cardiovascular: LVEF at least 50% by MUGA or normal on echocardiogram Pulmonary: DLCO at least 50% of predicted Other: HIV seronegative No uncontrolled infection Negative pregnancy test required of fertile women

PRIOR CONCURRENT THERAPY: See Disease Characteristics