Radiation Therapy and Cyclophosphamide Plus Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Hodgkin's Disease or Non-Hodgkin's Lymphoma

August 25, 2011 updated by: Northwestern University

Autologous Blood Stem Cell Transplantation in Patients With Hodgkin's Disease and Non-Hodgkin's Lymphoma With High-Dose Cyclophosphamide, Total Body Irradiation and Involved-Field Radiation Therapy

RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy and cyclophosphamide plus peripheral stem cell transplantation in treating patients who have recurrent or refractory Hodgkin's disease or non-Hodgkin's lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the toxicity of autologous peripheral blood stem cell transplantation following involved field radiotherapy, high dose cyclophosphamide, and total body irradiation in patients with recurrent or refractory Hodgkin's disease or non-Hodgkin's lymphoma. II. Determine the response in patients treated with this regimen.

OUTLINE: Patients undergo involved field radiotherapy on days -16 to -7. Patients receive cyclophosphamide IV over 2 hours on days -6 and -5. Patients undergo total body irradiation twice daily on days -4 to -1. Autologous peripheral blood stem cells are reinfused on day 0. Patients are followed every month for 1 year.

PROJECTED ACCRUAL: Not specified

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically proven Hodgkin's disease or non-Hodgkin's lymphoma that is refractory to standard therapy or has relapsed following initial response Eligible non-Hodgkin's lymphoma: Low grade Intermediate grade Immunoblastic large cell lymphoma (high grade) Eligible for involved field radiotherapy, cyclophosphamide, and total body irradiation No CNS non-Hodgkin's lymphoma or Hodgkin's disease 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: Physiologic age 65 and under Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min if creatinine 1.5-2 mg/dL Cardiovascular: No active heart disease (congestive heart failure, history of myocardial infarction within the past 3 months, or significant arrhythmia) requiring medication Pulmonary: No nonneoplastic pulmonary disease (e.g., chronic obstructive pulmonary disease) that would preclude intensive chemotherapy DLCO at least 50% predicted* FEV1 and/or FVC at least 75% predicted* * Unless due to underlying lymphoma or Hodgkin's disease Other: No other concurrent medical condition that would preclude aggressive cytotoxic chemotherapy HIV negative No clinical evidence of AIDS

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1999

Primary Completion (Actual)

June 1, 2002

Study Completion (Actual)

June 1, 2002

Study Registration Dates

First Submitted

March 7, 2000

First Submitted That Met QC Criteria

March 2, 2004

First Posted (Estimate)

March 3, 2004

Study Record Updates

Last Update Posted (Estimate)

August 26, 2011

Last Update Submitted That Met QC Criteria

August 25, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU 87H5T
  • NU-87H5T
  • NCI-G00-1693

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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