Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Relapsed Acute Lymphocytic Leukemia

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

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 combination chemotherapy followed by peripheral stem cell transplantation in treating children who have relapsed acute lymphocytic leukemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nebraska
• Treatments: Carmustine; Cyclophosphamide; Cytarabine; Etoposide; Sargramostim

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of acute lymphoblastic leukemia

• Pathologic evidence of relapse in marrow, CNS, or testes

• In second or later complete remission

• Ineligible for allogeneic transplantation:

• No suitable allogeneic donor (sibling or family donor or unrelated donor with no more than 1 HLA-A or -B antigen mismatch and HLA-DR identical) OR

• Ineligible for preparative regimen including total-body irradiation

• Peripheral blood stem cell collection feasible:

• Patient size generally at least 8 kg

• Able to place central venous catheter

• Patient cooperative

PATIENT CHARACTERISTICS:

Age:

• 1 to 19

Performance status:

• Not moribund

Life expectancy:

• No severe limits from disease other than leukemia

Hepatic:

• Bilirubin no greater than 3 times normal for age

• AST and/or GGT no greater than 3 times normal for age

• No evidence of hepatic synthetic dysfunction

Renal:

• GFR at least 50% of normal based on Glofil study or 12-hour creatinine clearance

Cardiovascular:

• Cardiac contractility normal on echocardiogram

Pulmonary:

• FVC and FEV_1 with or without DLCO at least 50% predicted

Other:

• No significant active infection

• HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

Surgery

• Not specified