Chemotherapy and Radiation Therapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory T-cell Lymphoma, Hodgkin's Lymphoma, or Non-Hodgkin's Lymphoma

NCT ID: NCT00004907

Last Updated: 2012-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-10-31
• Study Completion Date: 2004-08-31

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. Bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and radiation therapy and kill more cancer cells.

PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy and radiation therapy plus bone marrow or peripheral stem cell transplantation in treating patients who have refractory or relapsed T-cell lymphoma, Hodgkin's lymphoma, or non-Hodgkin's lymphoma.

Detailed Description

OBJECTIVES:

• Determine the toxicity of an intensive program of chemoradiotherapy followed by HLA identical related bone marrow or peripheral blood stem cell transplantation in patients with relapsed or refractory cutaneous T-cell lymphoma, Hodgkin's lymphoma, or non-Hodgkin's lymphoma.
• Determine the response rate and disease free survival in patients treated with this regimen.

OUTLINE: HLA identical related donors undergo harvest of bone marrow or peripheral blood stem cells (PBSC).

Patients are assigned to one of two treatment groups based on prior radiation to abdomen or mediastinum:

• Group A (prior radiation no greater than 2,000 cGy): Patients with complete response (CR) or partial response (PR) after completion of chemotherapy receive cyclophosphamide IV over 1 hour on days -6 and -5, followed by total body irradiation twice daily on days -4 to -1. Patients with minimal response after completion of chemotherapy receive cyclophosphamide IV over 1 hour on days -8 and -7, followed by etoposide IV over 30 hours beginning on day -6, followed by total body irradiation twice daily on days -4 to -1.
• Group B (prior radiation greater than 2,000 cGy): Patients with CR or PR after completion of chemotherapy receive oral busulfan every 6 hours on days -7 to -4, followed by cyclophosphamide IV over 1 hour on days -3 and -2. Patients with minimal response after completion of chemotherapy receive oral busulfan every 6 hours on days -9 to -6, followed by cyclophosphamide IV over 1 hour on days -5 and -4, followed by etoposide IV over 30 hours beginning on day -3.
• Both groups: Bone marrow or PBSC are reinfused on day 0. Patients with bulky nodal disease (greater than 5 cm) may undergo involved field radiotherapy two weeks before transplantation.

Patients are followed every month for 1 year.

PROJECTED ACCRUAL: Not specified

Conditions

Lymphoma

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

busulfan

Intervention Type: DRUG

cyclophosphamide

Intervention Type: DRUG

etoposide

Intervention Type: DRUG

allogeneic bone marrow transplantation

Intervention Type: PROCEDURE

bone marrow ablation with stem cell support

Intervention Type: PROCEDURE

peripheral blood stem cell transplantation

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Relapse following autologous bone marrow transplantation allowed if an HLA identical related donor is available
• Eligible for total body irradiation
• No active uncontrolled CNS disease NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age:

• Over 15 to physiologic age 60

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• No congestive heart failure
• No myocardial infarction within the past 3 months
• No significant arrhythmia requiring medication
• Resting LVEF normal

Pulmonary:

• No significant nonneoplastic pulmonary disease (e.g., chronic obstructive pulmonary disease) that would preclude therapy with cytotoxic drugs
• DLCO at least 50% of predicted* OR
• FEV1 and/or FVC at least 50% of predicted* NOTE: * Unless due to lymphoma, including Hodgkin's lymphoma

Other:

• Not pregnant
• Negative pregnancy test
• No active serious medical condition that would preclude aggressive cytotoxic chemotherapy
• HIV negative and no clinical evidence of AIDS

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leo I. Gordon, MD

Role: STUDY_CHAIR

Robert H. Lurie Cancer Center

Locations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, United States

Countries

United States

Other Identifiers

NU-95H4T

Identifier Type: -

Identifier Source: secondary_id

NCI-G00-1692

Identifier Type: -

Identifier Source: secondary_id

NU 95H4T

Identifier Type: -

Identifier Source: org_study_id