Adult Non-Hodgkin's Lymphoma |
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Clinical Trial: 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 no longer recruiting patients.
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 | Treatment or Intervention | Phase |
|---|---|---|
| recurrent diffuse small lymphocytic/marginal zone lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent grade III follicular large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent childhood Hodgkin's disease recurrent adult diffuse large cell lymphoma recurrent childhood large cell lymphoma recurrent adult Hodgkin's disease recurrent grade I follicular small cleaved cell lymphoma recurrent grade II follicular mixed cell lymphoma | Drug: cyclophosphamide | Phase II |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Hodgkin's Disease; Lymphatic Diseases; Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study 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
Study start: November 1999
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.
PROTOCOL 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
Criteria
PROTOCOL ENTRY 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.]
--Prior/Concurrent Therapy--
- See Disease Characteristics
--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
Location Information
Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, 60611-3013, United States
Jane N. Winter, Study Chair, Robert H. Lurie Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: March 2004
Last Updated: October 13, 2004
Record first received: March 7, 2000
ClinicalTrials.gov Identifier: NCT00004908
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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