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Autologous Blood Stem Cell Transplantation in Patients With Hodgkin's Disease and Non-Hodgkin's Lymphoma Who Have Had Prior 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 Who Have Had Prior Radiation Therapy


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

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Leo I. Gordon, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Federal Government

Study ID:

NU 87H6T

NCT ID:

NCT00004171

Start Date:

October 1999

Completion Date:

June 2002

Related Keywords:

  • Lymphoma
  • 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
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611