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

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
Robert H. Lurie Cancer Center
Information provided by: National Cancer Institute (NCI)

Purpose

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 Treatment or Intervention Phase
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
childhood immunoblastic large cell lymphoma
recurrent childhood Hodgkin's disease
recurrent adult diffuse large cell lymphoma
recurrent adult Hodgkin's disease
 Drug: busulfan
 Drug: cyclophosphamide
Phase II

MedlinePlus related topics:  Hodgkin's Disease;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Autologous Peripheral Blood Stem Cell Transplantation Following Radiotherapy in Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma

Further Study Details: 

Study start: October 1999

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.

PROTOCOL 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

Eligibility

Ages Eligible for Study:  up to  65 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

[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--

  • Biologic therapy: Not specified
  • Chemotherapy: See Disease Characteristics
  • Endocrine therapy: Not specified
  • Radiotherapy: See Disease Characteristics
  • Surgery: Not specified

--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

Location Information


Illinois
      Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago,  Illinois,  60611-3013,  United States

Study chairs or principal investigators

Leo I. Gordon,  Study Chair,  Robert H. Lurie Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067416; NU-87H6T; NCI-G99-1638
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004171
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005