Total-Body Irradiation, Fludarabine, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with donor peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining total-body irradiation with fludarabine and donor peripheral stem cell transplantation in treating patients who have hematologic cancer.

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

Details

• Lead Sponsor: Simmons Cancer Center; University of Texas Southwestern Medical Center
• Treatments: Cyclosporine; Cyclosporins; Fludarabine; Fludarabine phosphate; Mycophenolate mofetil; Mycophenolic Acid; Vidarabine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of one of the following hematologic malignancies:

• Chronic myelogenous leukemia (CML)

• First or second chronic phase

• Accelerated phase

• Acute myelogenous leukemia (AML)

• At least second remission

• First remission allowed if poor-risk features are present (complex chromosome karyotype, abnormalities of chromosomes, especially 5 or 7, 12p-, +13, +8, t[9:11])

• Myelodysplastic syndromes (MDS)

• Intermediate- or high-risk disease by the prognostic scoring system

• Multiple myeloma (MM)

• Hodgkin's lymphoma

• Second or greater relapse

• First relapse allowed if disease-free interval is less than 1 year

• Ineligible for autologous transplantation

• Non-Hodgkin's lymphoma (NHL)

• Grade III follicular large cell (relapsed after one course of prior chemotherapy)

• Diffuse large cell (relapsed after one course of prior chemotherapy)

• Mantle cell

• Chronic lymphocytic leukemia (CLL)

• Relapsed after at least 1 course of prior therapy

• Must have 6 out of 6 HLA A-, B-, and DR- identical sibling donor

PATIENT CHARACTERISTICS:

Age

• 18 to 75 for patients with MM

• 50 to 75 for patients with CML, AML, MDS, Hodgkin's lymphoma, NHL, or CLL

• 18 to 49 for patients with CML, AML, MDS, Hodgkin's lymphoma, NHL, or CLL who are considered eligible for an allogeneic bone marrow transplantation (BMT) but do not meet institutional criteria for a standard allogeneic BMT

Performance status

• Zubrod 0-2

Life expectancy

• At least 6 months

Hematopoietic

• Not specified

Hepatic

• Bilirubin no greater than 3 mg/dL

Renal

• Creatinine no greater than 2 mg/dL

Cardiovascular

• LVEF at least 40% by MUGA or echocardiogram

Pulmonary

• DLCO at least 50% of predicted

Other

• HIV negative

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No recent history of drug or alcohol abuse

• No other prior malignancy except basal cell skin cancer

• No uncontrolled bacterial, viral, fungal, or parasitic infections

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Prior autologous transplantation allowed if disease progression occurred

• No prior or concurrent tandem autologous transplantation followed by non-myeloablative-allograft protocol

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified