Clinical Trial: Peripheral Stem Transplantation in Treating Patients With Refractory or Relapsed Lymphoma

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: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with autologous and allogeneic peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs to kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects of autologous peripheral stem cell transplantation followed by allogeneic peripheral stem cell transplantation and to see how well they work in treating patients with refractory or relapsed lymphoma.

Condition Treatment or Intervention Phase
childhood Hodgkin's lymphoma
childhood non-Hodgkin's lymphoma
Graft Versus Host Disease
Lymphoma
 Drug: autologous lymphocytes
 Drug: carmustine
 Drug: cyclophosphamide
 Drug: cyclosporine
 Drug: cytarabine
 Drug: etoposide
 Drug: melphalan
 Drug: mycophenolate mofetil
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: chemotherapy
 Procedure: graft versus host disease prophylaxis/therapy
 Procedure: graft versus tumor induction
 Procedure: leukocyte therapy
 Procedure: peripheral blood lymphocyte therapy
 Procedure: peripheral blood stem cell transplantation
 Procedure: radiation therapy
 Procedure: supportive care/therapy
Phase I
Phase II

MedlinePlus related topics:  Hodgkin's Disease;   Immune System and Disorders;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I/II Study of Autologous Peripheral Blood Stem Cell (PBSC) Transplantation Followed by Nonmyeloablative Allogeneic PBSC Transplantation in Patients With Refractory or Relapsed Lymphoma

Further Study Details: 

OBJECTIVES: Primary

Secondary

  • Determine disease-free and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to response to prior chemotherapy (sensitive vs resistant).

Patients who do not have autologous peripheral blood stem cells (PBSC) stored receive mobilization on another protocol, then have PBSC collected and stored. Patients then proceed to conditioning and transplantation.

Patients may receive one of two conditioning regimens.

Within 40-120 days after autologous PBSC transplantation, patients proceed to nonmyeloablative allograft. Cyclosporine administered orally twice daily on days -3 to 56, then tapered based on disease risk. TBI is administered on day 0 followed by allogeneic PBSC infusion. Patients also receive oral mycophenolate mofetil twice a day beginning on day 0 and continuing until day 27.

Based on day 56 disease status, patients may receive donor lymphocyte infusion (DLI) if there is evidence of disease progression and no evidence of graft-vs-host disease. DLI may be repeated every 65 days for up to 4 doses.

Patients are followed weekly for 3 months, at 4 and 6 months, every 6 months for 2 years, and then annually until 5 years after transplantation.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.

Eligibility

Ages Eligible for Study:  up to  65 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Primary Hodgkin's or non-Hodgkin's lymphoma
  • Refractory or relapsed disease after standard chemotherapy
  • At high-risk of relapse with conventional autografting
  • Tumor detectable by radiograph or bone marrow biopsy
  • HLA genotypically- or phynotypically-identical related donor available
  • Not identical twin
  • Age 12 and over
  • Able to donate peripheral blood stem cells (PBSC) and lymphocytes

PATIENT CHARACTERISTICS: Age:

  • 65 and under

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 3 months
  • No life expectancy severely limited by disease other than lymphoma

Hematopoietic:

  • Not specified

Hepatic:

  • Not at high risk for veno-occlusive disease of the liver
  • Bilirubin no greater than 2.0 mg/dL
  • SGOT or SGPT no greater than 2 times normal

Renal:

  • Creatinine no greater than 2.0 mg/dL
  • Creatinine clearance at least 50 mL/min

Cardiovascular:

  • Cardiac ejection fraction at least 45% by MUGA or cardiac echo (for patients with a history of cardiac disease or anthracycline use)
  • No poorly controlled hypertension

Pulmonary:

  • DLCO at least 50% of predicted

Other:

  • HIV negative
  • Not pregnant
  • Fertile patients must use effective contraception during and for 1 year after study participation

PRIOR CONCURRENT THERAPY: Biologic therapy:

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 3 months since prior radiotherapy to the mediastinum

Surgery:

  • Not specified

Location and Contact Information


Utah
      Huntsman Cancer Institute at University of Utah, Salt Lake City,  Utah,  84112,  United States; Recruiting
Michael A. Pulsipher, MD  801-224-0421    michael.pulsipher@hsc.utah.edu 

Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109-1024,  United States; Recruiting
David G. Maloney, MD, PhD  206-667-5616    dmaloney@fhcrc.org 

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

Study chairs or principal investigators

David G. Maloney, MD, PhD,  Study Chair,  Fred Hutchinson Cancer Research Center   

More Information

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

Study ID Numbers:  CDR0000067779; FHCRC-1409.00; NCI-G00-1776; NCT00005803
Record last reviewed:  June 2004
Last Updated:  February 7, 2005
Record first received:  June 2, 2000
ClinicalTrials.gov Identifier:  NCT00005803
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


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