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

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ClinicalTrials.gov Identifier: NCT00004171
Recruitment Status : Completed
First Posted : March 1, 2004
Last Update Posted : June 12, 2012
Information provided by (Responsible Party):

December 10, 1999
March 1, 2004
June 12, 2012
October 1999
June 2002   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00004171 on ClinicalTrials.gov Archive Site
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Peripheral Stem Cell Transplantation Following Radiation Therapy in Treating Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma
Autologous Blood Stem Cell Transplantation in Patients With Hodgkin's Disease and Non-Hodgkin's Lymphoma Who Have Had Prior Radiation Therapy

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.

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.


Phase 2
Primary Purpose: Treatment
  • Drug: busulfan
  • Drug: cyclophosphamide
  • Procedure: peripheral blood stem cell transplantation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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June 2002
June 2002   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
up to 65 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
NU 87H6T
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Northwestern University
Northwestern University
National Cancer Institute (NCI)
Study Chair: Leo I. Gordon, MD Robert H. Lurie Cancer Center
Northwestern University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP