High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor 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 tumor cells.

PURPOSE: This phase II trial is studying how well giving busulfan, cyclophosphamide, and filgrastim together with peripheral stem cell transplantation from a sibling donor works in treating patients with hematologic cancer.

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

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Busulfan; Cyclophosphamide; Cyclosporine; Cyclosporins; Lenograstim

Criteria

DISEASE CHARACTERISTICS:

• Histologically diagnosed:

• Acute myeloid leukemia in first, second, or third complete remission or first or second early relapse

• Acute lymphoblastic leukemia in first, second, or third complete remission or first or second early relapse

• Hodgkin's lymphoma in second or third remission or first, second, or third relapse, or refractory

• Non-Hodgkin's lymphoma in second or third remission or first, second, or third relapse, or refractory

• Multiple myeloma and plasma cell leukemia in second or third remission or first, second, or third relapse, or refractory

• Myelodysplastic syndrome deemed suitable for allogeneic bone marrow transplantation

• No symptoms or signs of CNS involvement and CNS is disease free on lumbar puncture and brain CT scan

• No active meningeal cancer

PATIENT CHARACTERISTICS:

Age:

• 4 to 55 (4 to 60 if donor is identical twin)

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• SGOT/SGPT less than 3 times normal

• Bilirubin less than 2.0 mg/dL

Renal:

• Creatinine less than 2.1 mg/dL

• Creatinine clearance at least 60 mL/min (no greater than 1.5 times normal for children under 40 kg)

Cardiovascular:

• No uncontrolled hypertension

• No uncontrolled congestive heart failure

• No active angina pectoris requiring nitrates

• At least 6 months since prior myocardial infarction

• No major ventricular arrhythmia

• Left ventricular ejection fraction at least 45% on MUGA

Pulmonary:

• No severe or symptomatic restrictive or obstructive lung disease

• FEV_1 greater than 50% of predicted

• DLCO greater than 50% of predicted

Neurologic:

• No severe central or peripheral neurologic abnormality

Other:

• Must have HLA-A,B,C,D/DR identical sibling age 4 to 65, in good health

• No insulin-dependent diabetes mellitus

• No major thyroid or major adrenal dysfunction

• No active infection

• No other active malignancy

• Not pregnant

• HIV negative

• HTLV-I and HTLV-II negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No excessive anthracycline exposure, unless endomyocardial biopsy shows less than grade 2 drug effect and cardiac scan shows at least 50% ejection fraction

• At least 1 year since prior autologous bone marrow or peripheral blood progenitor cell transplant or allogeneic bone marrow transplant

Chemotherapy:

• At least 3 weeks since prior chemotherapy

• No prior excessive carmustine and bleomycin

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 3 weeks since prior radiotherapy

Surgery:

• Not specified

Other:

• No concurrent nitroglycerin for angina pectoris

• No concurrent anti-arrhythmic drugs for major ventricular dysrhythmias