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Radiation Therapy and Cyclophosphamide Plus Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Hodgkin's Disease or Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
First Received: March 7, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004908
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: cyclophosphamide
Procedure: peripheral blood stem cell transplantation
Radiation: radiation therapy
Phase II

MedlinePlus related topics: Cancer Hodgkin's Disease Lymphoma Radiation Therapy
Drug Information available for: Cyclophosphamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 1999
Primary Completion Date: June 2002 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004908

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Robert H. Lurie Cancer Center
Investigators
Study Chair: Jane N. Winter, MD Robert H. Lurie Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067588, NU-87H5T, NCI-G00-1693
Study First Received: March 7, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00004908     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult Hodgkin lymphoma
recurrent/refractory childhood Hodgkin lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent childhood large cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma

Study placed in the following topic categories:
Immunologic Factors
Hodgkin Lymphoma, Childhood
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Cyclophosphamide
Follicular Lymphoma
Lymphoma, Large-cell, Immunoblastic
Lymphoma, B-Cell
Lymphoma, Small Cleaved-cell, Diffuse
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large-Cell, Immunoblastic
Leukemia, B-cell, Chronic
Lymphoma, Large-cell
Alkylating Agents
Hodgkin Disease
Lymphoma
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Hodgkin Lymphoma, Adult
Hodgkin's Disease
Immunosuppressive Agents
Recurrence
Lymphatic Diseases
Chronic Lymphocytic Leukemia
B-cell Lymphomas
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Cyclophosphamide
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Alkylating Agents
Hodgkin Disease
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009