Peripheral Stem Cell Transplantation With Specially Treated Stem Cells in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Disease
|ClinicalTrials.gov Identifier: NCT00005998|
Recruitment Status : Withdrawn (Withdrawn because study never enrolled patients)
First Posted : October 8, 2003
Last Update Posted : November 29, 2017
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy and radiation therapy with peripheral stem cell transplantation using specially treated stem cells may allow the doctor to give higher doses of chemotherapy drugs and radiation therapy and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation using specially treated stem cells in treating patients who have non-Hodgkin's lymphoma or Hodgkin's disease.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: carmustine Drug: cyclophosphamide Drug: cytarabine Drug: dexamethasone Drug: etoposide Drug: filgrastim Drug: mitoxantrone hydrochloride Drug: retrovirus vector LN Procedure: in vitro-treated peripheral blood stem cell transplantation Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy||Phase 2|
- Determine whether priming with hematopoietic cytokines and chemotherapy increases the yield of hematopoietic progenitors in peripheral blood stem cells (PBSC) in patients with non-Hodgkin's lymphoma or Hodgkin's disease undergoing autologous PBSC transplantation.
- Determine whether in vitro studies can predict the transduction efficiency of early and late engrafting hematopoietic stem cells in this patient population undergoing this treatment.
- Determine whether in vitro transduction of a graft product stable long term transduction of marrow cells in these patients after autologous transplantation.
OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously (SC) twice daily on days 1-7. Peripheral blood stem cells (PBSC) are collected on days 5-7. Patients receive cyclophosphamide IV over 2 hours, mitoxantrone IV, and cytarabine IV every 12 hours for 2 doses on day 10, and dexamethasone every 12 hours for 4 doses on days 10 and 11. Patients receive G-CSF SC for the next 10-20 days. Additional PBSC are collected on days 25-28 or 29. Beginning 7 days before PBSC transplantation, patients receive cyclophosphamide IV over 2 hours on days -7 and -6 and total body irradiation (TBI) twice daily on days -4 to -1. Patients unable to tolerate TBI receive cyclophosphamide IV over 2 hours on days -6 to -3, carmustine IV over 1 hour on days -6, and etoposide IV over 1 hour every 12 hours on days -6 to -4. Retrovirally transduced PBSC are reinfused on day 0 followed by another course of G-CSF SC until hematopoietic recovery.
Patients are followed at 1, 3, 6, 9, 12, 18, and 24 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 15-20 patients will be accrued for this study within 12-15 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Official Title:||Autologous Transplantation for Non-Hodgkin's Lymphoma and Hodgkin's Disease Using Retrovirally Marked Peripheral Blood Progenitor Cells Obtained After In Vivo Mobilization Using Hematopoietic Cytokines Plus Chemotherapy|
|Study Start Date :||January 2000|
|Actual Primary Completion Date :||March 2003|
|Actual Study Completion Date :||March 2003|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005998
|Study Chair:||Daniel J. Weisdorf, MD||Masonic Cancer Center, University of Minnesota|