Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

NCT00005092 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2018-10-26

No results posted yet for this study

Summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy used to kill tumor cells. Sometimes the transplanted cells are rejected by the body's normal tissues. Transplanting donated cells that have been treated with psoralen may prevent this from happening.

PURPOSE: Phase I trial to study the effectiveness of chemotherapy, radiation therapy, and psoralen-treated donor cells in treating patients who are undergoing peripheral stem cell transplantation for hematologic cancer.

Conditions

Interventions

DRUG

Cyclophosphamide

IV over 2 hours on days 2 and 3

DRUG

Psoralen

Psoralen treated T-cell allogeneic transplant on day 9

DRUG

Thiotepa

IV over 2 hours on day 1

PROCEDURE

Allogeneic bone marrow transplantation

Preserved stem cell or bone marrow allogeneic transplant plus psoralen treated T-cell allogeneic transplant on day 9

PROCEDURE

In vitro-treated peripheral blood stem cell transplantation (PBSCT)

Preserved stem cell or bone marrow allogeneic transplant plus psoralen treated T-cell allogeneic transplant on day 9

RADIATION

Radiation Therapy (RT)

Whole body radiotherapy on days 5-8.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • James Gajewski, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
49 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-05-28
Primary Completion
2002-08-28
Completion
2002-08-28

Countries

  • United States

Study Locations

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Entities

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 NCT00005092 on ClinicalTrials.gov