Overview
Autologous Stem Cell Transplant in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma
Status:
Completed
Completed
Trial end date:
2010-04-01
2010-04-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
RATIONALE: Giving two autologous stem cell transplants (one after the other) may be an effective treatment for Hodgkin's lymphoma. PURPOSE: This phase II trial is studying how well giving two autologous stem cell transplants works in treating patients with progressive or recurrent Hodgkin's lymphoma.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Case Comprehensive Cancer CenterCollaborator:
National Cancer Institute (NCI)Treatments:
Busulfan
Cyclophosphamide
Etoposide
Melphalan
Criteria
DISEASE CHARACTERISTICS:- Histologically* confirmed Hodgkin's lymphoma meeting ≥ 1 of the following criteria:
- Disease progression during initial first line chemotherapy
- Complete response lasting ≤ 90 days after induction
- Partial response lasting ≤ 90 days after induction
- First recurrence/progression with the duration of initial response ≤ 12 months
after completion of chemotherapy NOTE: *There must be unequivocal radiological
evidence of recurrent or progressive disease if biopsy was not obtained at time
of disease recurrence/progression
- No clonal abnormalities in marrow collection
- Must have bilateral or unilateral bone marrow aspirates and biopsy within 42 days
prior to stem cell collection
- Must have adequate sections of original diagnostic specimen available for review
- Needle aspirations or cytologies are not adequate
- No prior lymphoma, myelodysplastic syndromes, or leukemia (even if disease free ≥ 5
years)
- No CNS involvement
PATIENT CHARACTERISTICS:
Performance status
- Karnofsky 50-100%
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal* (ULN) NOTE: *Unless due to Hodgkin's
lymphoma
Renal
- Creatinine clearance ≥ 60 mL/min
- Creatinine ≤ 2.0 times ULN
Cardiovascular
- Ejection fraction ≥ 45% by 2-D echocardiogram
- No significant active cardiac disease
Pulmonary
- Adequate pulmonary function
- DLCO ≥ 45%
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer
- No known HIV or AIDS infection
- No active bacterial, fungal, or viral infection
- No medical condition that would preclude study treatment
PRIOR CONCURRENT THERAPY:
Chemotherapy
- See Disease Characteristics
Surgery
- See Disease Characteristics