Chemotherapy Plus Donor White Blood Cell Infusion in Treating Patients With Relapsed Hematologic Cancer Following Donor Peripheral Stem Cell Transplantation

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Completed
CT.gov ID
NCT00005946
Collaborator
(none)
1
20

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. White blood cells from donors may be able to prevent graft-versus-host disease in patients with hematologic cancer that has relapsed following donor peripheral stem cell transplantation.

PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus donor white blood cell infusion in treating patients who have relapsed hematologic cancer following donor peripheral stem cell transplantation.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

OBJECTIVES: I. Determine the minimum amount of chemotherapy in combination with donor lymphocyte infusion required to obtain a rate of 30-60% graft versus host disease in patients with hematologic malignancies relapsed after allogeneic stem cell transplantation.

OUTLINE: This is a dose de-escalation study. Patients receive etoposide IV continuously on days 1-3; cyclophosphamide IV on day 8; donor lymphocyte infusion IV on day 10; and filgrastim (G-CSF) subcutaneously or IV beginning on day 10 and continuing until blood counts recover. Cohorts of 3-6 patients receive six de-escalating levels of chemotherapy until the minimum amount of chemotherapy in combination with donor lymphocyte infusion required to obtain a rate of 30-60% graft versus host disease (GVHD) is determined. The target dose level is defined as the level at which 2 of 6 patients develop GVHD, and the next lower dose level has no more than 1 patient experiencing GVHD. Patients are followed every 3 months for the first year, every 6 months for the second year, and yearly thereafter.

PROJECTED ACCRUAL: A total of 18-21 patients will be accrued over 2 years.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
A Pilot Study of Combined Chemotherapy and Donor Lymphocyte Infusion for Hematologic Malignancies in Relapse After Allogeneic Bone Marrow Transplantation
Actual Study Start Date :
Oct 1, 2000
Actual Primary Completion Date :
Jun 1, 2002
Actual Study Completion Date :
Jun 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    DISEASE CHARACTERISTICS: Histologically confirmed relapsed or refractory hematologic malignancy Acute leukemia Myelodysplasia Non-Hodgkin's lymphoma Hodgkin's disease Multiple myeloma Chronic lymphocytic leukemia Chronic myeloid leukemia Accelerated phase or blast crisis Chronic phase with failed prior donor lymphocyte infusion No active acute or extensive chronic graft versus host disease Prior allogeneic stem cell transplant (SCT) required At least 60 days since prior SCT Nonmyeloablative SCT allowed

    PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy:

    Greater than 4 weeks Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No severe psychiatric illness that may preclude informed consent Fertile patients must use effective contraception

    PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 7 days since prior immunomodulatory medications (e.g., interferon or interleukin-2) Chemotherapy: Not specified Endocrine therapy: At least 7 days since prior steroids Radiotherapy: Not specified Surgery: Not specified Other: At least 7 days since prior immunosuppressives (e.g., cyclosporine, tacrolimus, or mycophenolate mofetil) No concurrent immunosuppressive medications for graft versus host disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore Maryland United States 21201

    Sponsors and Collaborators

    • University of Maryland, Baltimore

    Investigators

    • Study Chair: Bijoyesh Mookerjee, MD, Jefferson Medical College of Thomas Jefferson University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Maryland, Baltimore
    ClinicalTrials.gov Identifier:
    NCT00005946
    Other Study ID Numbers:
    • MSGCC-9951
    • CDR0000067863
    • NCI-V00-1588
    First Posted:
    Mar 5, 2004
    Last Update Posted:
    Oct 17, 2019
    Last Verified:
    Oct 1, 2019
    Keywords provided by University of Maryland, Baltimore
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 17, 2019