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Bone Marrow Transplantation in Treating Patients With Lymphoma

NCT ID: NCT00002829

Last Updated: 2012-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-02-28

Study Completion Date

2002-04-30

Brief Summary

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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

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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.

Conditions

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Lymphoma

Keywords

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Waldenstrom macroglobulinemia recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bone Marrow Transplantation

Group Type EXPERIMENTAL

Recombinant Interferon Alfa

Intervention Type BIOLOGICAL

Daily

Cyclophosphamide

Intervention Type DRUG

Infused intravenously over 2 hours daily on Day -7 and -6.

Etoposide

Intervention Type DRUG

Administered intravenously on Day -8

Mesna

Intervention Type DRUG

Beginning 1 hour after initiation of the cyclophosphamide treatment.

Bone Marrow Transplantation

Intervention Type PROCEDURE

Infusion on Day 0.

Radiation Therapy

Intervention Type RADIATION

Total body irradiation is received on days -4, -3, -2 , and -1.

Interventions

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Recombinant Interferon Alfa

Daily

Intervention Type BIOLOGICAL

Cyclophosphamide

Infused intravenously over 2 hours daily on Day -7 and -6.

Intervention Type DRUG

Etoposide

Administered intravenously on Day -8

Intervention Type DRUG

Mesna

Beginning 1 hour after initiation of the cyclophosphamide treatment.

Intervention Type DRUG

Bone Marrow Transplantation

Infusion on Day 0.

Intervention Type PROCEDURE

Radiation Therapy

Total body irradiation is received on days -4, -3, -2 , and -1.

Intervention Type RADIATION

Other Intervention Names

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Cytoxan Neosar VePesid Mesnex BMT RT Radiotherapy TBI

Eligibility Criteria

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Inclusion Criteria

PATIENT CHARACTERISTICS: Age: 15 to 60 years Performance Status: Zubrod 0-2 Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: Cardiac ejection fraction at least 50% Pulmonary: DLCO at least 50% Other: No concomitant severe medical illnesses No psychosis

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: No prior extensive radiotherapy Surgery: Not specified
Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard E. Champlin, MD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Locations

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University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

UT MD Anderson Cancer Center website

Other Identifiers

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P30CA016672

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MDA-DM-94009

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-G96-0994

Identifier Type: -

Identifier Source: secondary_id

CDR0000065027

Identifier Type: REGISTRY

Identifier Source: secondary_id

DM94-009

Identifier Type: -

Identifier Source: org_study_id