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Umbilical Cord Blood Transplantation in Treating Patients With High-Risk Hematologic Cancer

NCT00003335 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2012-03-15

No results posted yet for this study

Summary

RATIONALE: Umbilical cord blood transplantation may allow doctors to give higher doses of chemotherapy or radiation therapy and kill more cancer cells.

PURPOSE: This phase II trial is studying allogeneic umbilical cord blood transplantation to see how well it works when given with chemotherapy or radiation therapy in treating patients with high-risk hematologic cancer.

Conditions

Interventions

BIOLOGICAL

anti-thymocyte globulin

antithymocyte globulin IV for three days on days -3 to -1

DRUG

busulfan

If TBI is not tolerated, busulfan is substituted and administered orally every 6 hours for 4 days on days -8 to -5.

DRUG

cyclosporine

Cyclosporine begin on day -2 and continue for 6 months.

DRUG

melphalan

melphalan IV for three days on days -4 to -2

DRUG

methylprednisolone

Methylprednisolone IV for three days on days -3 to -1. Methylprednisolone begin on day -2 and continue for 6 months.

PROCEDURE

umbilical cord blood transplantation

On day 0, patients receive umbilical cord blood infusion.

RADIATION

radiation therapy

9 fractions of total body irradiation (TBI) on days -9 to -5

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Brenda W. Cooper, MD · Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
54 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-01-31
Primary Completion
2007-11-30
Completion
2012-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00003335 on ClinicalTrials.gov