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Clinical Trial: Chemotherapy Plus Donor White Blood Cell Infusion in Treating Patients With Relapsed Hematologic Cancer Following Donor Peripheral Stem Cell Transplantation
This study is no longer recruiting patients.
Purpose
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 | Treatment or Intervention | Phase |
|---|---|---|
| Leukemia Lymphoma | Drug: allogeneic lymphocytes Drug: cyclophosphamide Drug: etoposide Drug: filgrastim | Phase I |
MedlinePlus related topics: Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Pilot Study of Combined Chemotherapy and Donor Lymphocyte Infusion in Patients With Hematologic Malignancies in Relapse After Allogeneic Stem Cell Transplantation
Study start: October 2000
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.
PROTOCOL 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.
Eligibility
Criteria
PROTOCOL ENTRY CRITERIA:
--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
--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
--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
Location Information
Maryland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, 21201, United States
Bijoyesh Mookerjee, Study Chair, University of Maryland Greenebaum Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: March 2004
Last Updated: October 13, 2004
Record first received: July 5, 2000
ClinicalTrials.gov Identifier: NCT00005946
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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