Bone Marrow Transplantation in Treating Patients With Lymphoma
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|ClinicalTrials.gov Identifier: NCT00002829|
Recruitment Status : Completed
First Posted : May 26, 2004
Last Update Posted : July 30, 2012
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, and may be an effective treatment for lymphoma. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells.
PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating patients with recurrent or residual low-grade lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: Recombinant Interferon Alfa Drug: Cyclophosphamide Drug: Etoposide Drug: Mesna Procedure: Bone Marrow Transplantation Radiation: Radiation Therapy||Phase 2|
OBJECTIVES: I. Examine the potential role of high dose etoposide, cyclophosphamide, total body irradiation and bone marrow transplantation for patients at high risk for disease progression. II. Determine the value of monitoring the quality of remission by PCR assessment of BCl-2. III. Evaluate the efficacy of alpha interferon for patients with evidence of residual or recurrent lymphoma. IV. Evaluate the efficacy of bone marrow purging by PCR assessment of BCl-2.
OUTLINE: Patients receive a brief 2-3 cycles of intensive chemotherapy to achieve minimum disease state. Etoposide is administered intravenously on day -8. Cyclophosphamide is infused intravenously over 2 hours daily on day -7 and -6. Patients receive mesna beginning 1 hour after initiation of the cyclophosphamide treatment. Total body irradiation is received on days -4, -3, -2 , and -1. On day 0 allogeneic or autologous bone marrow is infused intravenously. Patients with residual or recurrent lymphoma receive interferon alpha daily.
PROJECTED ACCRUAL: 35 allogeneic and 40 autologous patients are expected to be enrolled.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Autologous and Allogeneic Bone Marrow Transplantation for Low Grade Lymphoma|
|Study Start Date :||February 1994|
|Actual Primary Completion Date :||April 2002|
|Actual Study Completion Date :||April 2002|
|Experimental: Bone Marrow Transplantation||
Biological: Recombinant Interferon Alfa
Infused intravenously over 2 hours daily on Day -7 and -6.
Administered intravenously on Day -8
Other Name: VePesid
Beginning 1 hour after initiation of the cyclophosphamide treatment.
Other Name: Mesnex
Procedure: Bone Marrow Transplantation
Infusion on Day 0.
Other Name: BMT
Radiation: Radiation Therapy
Total body irradiation is received on days -4, -3, -2 , and -1.
- Number of Patients with Response [ Time Frame: 2 Years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002829
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Richard E. Champlin, MD||M.D. Anderson Cancer Center|