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Bone Marrow Transplantation in Treating Patients With Lymphoma

Phase 2
Completed
Conditions
Lymphoma
Interventions
Biological: Recombinant Interferon Alfa
Procedure: Bone Marrow Transplantation
Radiation: Radiation Therapy
Registration Number
NCT00002829
Lead Sponsor
M.D. Anderson Cancer Center
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
45
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Bone Marrow TransplantationEtoposide-
Bone Marrow TransplantationMesna-
Bone Marrow TransplantationBone Marrow Transplantation-
Bone Marrow TransplantationRadiation Therapy-
Bone Marrow TransplantationRecombinant Interferon Alfa-
Bone Marrow TransplantationCyclophosphamide-
Primary Outcome Measures
NameTimeMethod
Number of Patients with Response2 Years
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Texas - MD Anderson Cancer Center

🇺🇸

Houston, Texas, United States

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