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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004908
• Other study ID #: NU 87H5T
• Secondary ID: NU-87H5TNCI-G00-
• Status: Completed
• Phase: Phase 2
• First received: March 7, 2000
• Last updated: August 25, 2011
• Start date: November 1999
• Est. completion date: June 2002

Study information

• Verified date: August 2011
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2002
• Est. primary completion date: June 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 65 Years

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• cyclophosphamide

Procedure:
• peripheral blood stem cell transplantation

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,