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

Sponsor

Northwestern University (Other)

Overall Status

Completed

CT.gov ID

NCT00004171

Collaborator

National Cancer Institute (NCI) (NIH)

Location

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: busulfan Drug: cyclophosphamide Procedure: peripheral blood stem cell transplantation	Phase 2

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

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 1999

Actual Primary Completion Date :

Jun 1, 2002

Actual Study Completion Date :

Jun 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 65 Years

Sexes Eligible for Study:

All

Accepts 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