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Peripheral Stem Cell Transplantation Following Radiation Therapy in Treating Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
busulfan
cyclophosphamide
peripheral blood stem cell transplantation
Sponsored by
Northwestern University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring recurrent adult Hodgkin lymphoma, childhood immunoblastic large cell lymphoma, recurrent/refractory childhood Hodgkin 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

Eligibility Criteria

undefined - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically proven Hodgkin's disease OR Histologically proven non-Hodgkin's lymphoma (NHL) Intermediate grade OR Large cell immunoblastic (high grade) Refractory to standard therapy or relapsed following initial complete remission Must have received radiotherapy to the extent that no longer eligible for involved field radiation, cyclophosphamide, or total body irradiation No CNS 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 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 Cardiovascular: No active heart disease No congestive heart failure No myocardial infarction in the last 3 months No significant arrhythmia requiring medication Pulmonary: No significant nonneoplastic pulmonary disease No chronic obstructive pulmonary disease Diffusing capacity at least 50% predicted OR FEV1 and/or FVC at least 75% predicted (unless due to NHL or Hodgkin's disease) Other: HIV negative No clinical evidence of AIDS PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified

Sites / Locations

  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 10, 1999
Last Updated
June 8, 2012
Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004171
Brief Title
Peripheral Stem Cell Transplantation Following Radiation Therapy in Treating Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma
Official Title
Autologous Blood Stem Cell Transplantation in Patients With Hodgkin's Disease and Non-Hodgkin's Lymphoma Who Have Had Prior Radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
June 2002 (Actual)
Study Completion Date
June 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: 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 the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have Hodgkin's disease or non-Hodgkin's lymphoma.
Detailed Description
OBJECTIVES: I. Determine the toxicity and response to intensive chemotherapy followed by autologous peripheral blood stem cell transplantation in patients with Hodgkin's disease or non-Hodgkin's lymphoma who have received prior chemotherapy and/or radiotherapy. OUTLINE: Patients receive oral busulfan every 6 hours on days -9 to -6 and cyclophosphamide IV over 2 hours on days -5 to -2. Autologous peripheral blood stem cells are reinfused on day 0. Patients are followed monthly for 1 year. PROJECTED ACCRUAL: Not specified

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
recurrent adult Hodgkin lymphoma, childhood immunoblastic large cell lymphoma, recurrent/refractory childhood Hodgkin 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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
busulfan
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation

10. Eligibility

Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven Hodgkin's disease OR Histologically proven non-Hodgkin's lymphoma (NHL) Intermediate grade OR Large cell immunoblastic (high grade) Refractory to standard therapy or relapsed following initial complete remission Must have received radiotherapy to the extent that no longer eligible for involved field radiation, cyclophosphamide, or total body irradiation No CNS 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 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 Cardiovascular: No active heart disease No congestive heart failure No myocardial infarction in the last 3 months No significant arrhythmia requiring medication Pulmonary: No significant nonneoplastic pulmonary disease No chronic obstructive pulmonary disease Diffusing capacity at least 50% predicted OR FEV1 and/or FVC at least 75% predicted (unless due to NHL or Hodgkin's disease) Other: HIV negative No clinical evidence of AIDS PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leo I. Gordon, MD
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Peripheral Stem Cell Transplantation Following Radiation Therapy in Treating Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma

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