Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer

NCT ID: NCT00003661

Last Updated: 2011-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-06-30
• Study Completion Date: 2006-03-31

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Umbilical cord blood transplantation may be able to replace cells destroyed by chemotherapy or radiation therapy.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy, radiation therapy, and umbilical cord blood transplantation in treating patients who have hematologic cancer.

Detailed Description

OBJECTIVES: I. Determine the rates of hematologic and immune reconstitution in pediatric patients with high risk hematologic malignancies in first remission or in second or subsequent remission, and adult patients with acute lymphocytic leukemia (ALL) or acute nonlymphocytic leukemia (ANLL) in second or subsequent remission, who are undergoing high dose chemoradiotherapy followed by unrelated umbilical cord blood (UCB) transplantation. II. Determine the incidence of graft-versus-host disease in this setting. III. Determine whether contamination of umbilical cord blood with maternal cells is a clinical problem in this setting. IV. Describe the incidence of leukemic relapse in these patients after UCB transplantation. V. Describe the incidence of serious infections and secondary lymphoproliferative diseases following transplantation with UCB in these patients. VI. Determine specifically whether larger recipients (greater than 40 kg) can be durably engrafted with unrelated UCB, and determine whether nucleated cell or progenitor cell content of the graft is predictive of hematological engraftment.

OUTLINE: Patients undergo a back-up bone marrow harvest prior to treatment. Patients receive 9 fractions of total body irradiation (TBI) on days -9 to -5, followed by melphalan IV on days -4 to -2 and antithymocyte globulin IV or methylprednisolone IV on days -3 to -1. If TBI is not allowed, busulfan is substituted and administered orally every 6 hours for 4 days on days -8 to -5. On day 0, patients receive umbilical cord blood infusion. Cyclosporine and methylprednisolone begin on day -2 and continue for 6 months. Patients are followed indefinitely for survival and late toxicity.

PROJECTED ACCRUAL: A minimum of 48 patients will be accrued into this study within 4 years.

Conditions

Graft Versus Host Disease; Leukemia; Lymphoma; Myelodysplastic Syndromes; Neuroblastoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

anti-thymocyte globulin

Intervention Type: BIOLOGICAL

busulfan

Intervention Type: DRUG

cyclosporine

Intervention Type: DRUG

melphalan

Intervention Type: DRUG

methylprednisolone

Intervention Type: DRUG

umbilical cord blood transplantation

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

PATIENT CHARACTERISTICS: Age: Under 55 at time of umbilical cord blood transplantation Performance status: Zubrod 0-1 Lansky 80-100% Karnofsky 80-100% Life expectancy: At least 3 months Hematopoietic: Adequate hematologic status at time of back-up bone marrow harvest: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: ALT/AST no greater than 4 times normal Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 50 mL/min Cardiovascular: Normal cardiac function by echocardiogram or radionuclide scan (shortening fraction or ejection fraction at least 80% of normal value for age) Pulmonary: FVC and FEV1 at least 60% of predicted for age For adults: DLCO at least 60% of predicted Other: No active infections at time of back-up bone marrow harvest or pretransplant reduction Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

• Maximum Eligible Age: 54 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Roswell Park Cancer Institute

Principal Investigators

Barbara Jean Bambach, MD

Role: STUDY_CHAIR

Roswell Park Cancer Institute

Locations

University of Florida Health Science Center

Gainesville, Florida, United States

Division of Pediatric Surgery

Jacksonville, Florida, United States

Nemours Children's Clinic

Jacksonville, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, United States

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Children's Hospital of New Orleans

New Orleans, Louisiana, United States

Cardinal Glennon Children's Hospital

St Louis, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

North Shore University Hospital

Manhasset, New York, United States

New York Blood Center

New York, New York, United States

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, United States

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of South Carolina School of Medicine

Columbia, South Carolina, United States

Countries

United States

Other Identifiers

RPCI-RP-9801

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000066754

Identifier Type: -

Identifier Source: org_study_id