Clinical Trial: Pentostatin and Donor White Blood Cells in Preventing Graft Rejection in Cancer Patients Who Have Undergone Donor Stem Cell Transplantation

This study is currently recruiting patients.

Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by radiation therapy or chemotherapy used to kill cancer cells. Infusions of donor white blood cells may decrease the body's rejection of the transplanted peripheral stem cells. Pentostatin, mycophenolate mofetil, and cyclosporine may also prevent this from happening.

PURPOSE: This phase I/II trial is studying the side effects of pentostatin and donor white blood cells and to see how well they work in preventing graft rejection in cancer patients who have undergone a donor stem cell transplantation.

Condition Treatment or Intervention Phase
Cancer
Graft Versus Host Disease
 Drug: allogeneic lymphocytes
 Drug: cyclosporine
 Drug: mycophenolate mofetil
 Drug: pentostatin
 Procedure: biological response modifier therapy
 Procedure: chemotherapy
 Procedure: graft versus host disease prophylaxis/therapy
 Procedure: leukocyte therapy
 Procedure: peripheral blood lymphocyte therapy
 Procedure: supportive care/therapy
Phase I
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Immune System and Disorders

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I/II Study of Pentostatin and Donor Lymphocyte Infusion in Preventing Graft Rejection in Cancer Patients With Low or Falling Donor T-Cell Chimerism After Nonmyeloablative Allogeneic Stem Cell Transplantation

Further Study Details: 

OBJECTIVES: Primary

Secondary

  • Determine the incidence of graft-vs-host disease in patients treated with this regimen.
  • Determine the incidence of infections in patients treated with this regimen.
  • Determine disease response in patients with persistent disease treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive pentostatin IV over a few seconds or 20-30 minutes on day -2 and donor lymphocytes IV over 15-30 minutes on day 0. Treatment may repeat once beginning at least 28 days later. Patients are evaluated once 20 patients have been treated. If this regimen is found to be ineffective, subsequent patients receive pentostatin and donor lymphocytes as before, as well as oral cyclosporine twice daily beginning on day -3 and continuing until day 56. Patients also receive oral mycophenolate mofetil once daily beginning on day 0 and continuing until day 27.

Patients are followed monthly for 3 months, every 3 months for 6 months, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 20-80 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  up to  74 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Has undergone prior allogeneic stem cell transplantation for cancer
  • Received nonmyeloablative conditioning regimen comprising fludarabine and/or total body irradiation
  • Related or unrelated donor
  • Low or falling donor CD3-positive T-cell peripheral blood chimerism on 2 separate consecutive evaluations at least 14 days apart as indicated by 1 of the following:
  • < 50% chimerism
  • ≥ 20% decrease in chimerism AND second evaluation demonstrates < 50% chimerism
  • Persistent donor CD3-positive cells (≥ 5% by fluorescence hybridization or variable number of tandem repeats assay)
  • Evidence of disease allowed provided disease is persistent and stable compared to the status prior to transplantation
  • No relapsed or progressive disease after transplantation
  • Original stem cell donor available for further stem cell donation
  • Hormone receptor status:
  • Not specified

PATIENT CHARACTERISTICS: Age

  • Under 75

Sex

  • Not specified

Menopausal status

  • Not specified

Performance status

  • Karnofsky 50-100%

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

PRIOR CONCURRENT THERAPY: Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Steroids must be tapered to a dose ≤ 0.25 mg/kg/day within 1-2 weeks before donor lymphocyte infusion

Radiotherapy

  • See Disease Characteristics

Surgery

  • Not specified

Other


Location and Contact Information


Utah
      Huntsman Cancer Institute at University of Utah, Salt Lake City,  Utah,  84112,  United States; Recruiting
Michael A. Pulsipher, MD  801-585-0303    michael.pulsipher@hsc.utah.edu 

Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109-1024,  United States; Recruiting
Brenda Sandmaier, MD  206-667-4961 

Germany
      Universitaet Leipzig, Leipzig,  D-04103,  Germany; Recruiting
Dietger Niederwieser, MD  49-341-971-3050    dietger@medizin.uni_leipzig.de 

      Universitaetsklinikum Tuebingen, Tuebingen,  D-72076,  Germany; Recruiting
Wolfgang Bethge, MD  49-4707-1298-2711 

Italy
      Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino, Turin,  10126,  Italy; Recruiting
Benedetto Bruno, MD, PhD  39-011-633-9064    benedetto.bruno@unito.it 

Study chairs or principal investigators

Brenda Sandmaier, MD,  Principal Investigator,  Fred Hutchinson Cancer Research Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000391025; FHCRC-1825.00; SUPERGEN-FHCRC-1825.00; NCT00096161
Record last reviewed:  October 2004
Last Updated:  February 24, 2005
Record first received:  November 9, 2004
ClinicalTrials.gov Identifier:  NCT00096161
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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