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Autologous Blood Stem Cell Transplantation in Patients With Hodgkin's Disease and Non-Hodgkin's Lymphoma With High-Dose Cyclophosphamide, Total Body Irradiation and Involved-Field Radiation Therapy


Phase 2
N/A
65 Years
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Autologous Blood Stem Cell Transplantation in Patients With Hodgkin's Disease and Non-Hodgkin's Lymphoma With High-Dose Cyclophosphamide, Total Body Irradiation and Involved-Field Radiation Therapy


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.

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

Inclusion 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.

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

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Jane N. Winter, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NU 87H5T

NCT ID:

NCT00004908

Start Date:

November 1999

Completion Date:

June 2002

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent/refractory childhood Hodgkin lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular 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
  • recurrent childhood large cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611