Status:
COMPLETED
Autologous Stem Cell Transplant in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 autolog...
Detailed Description
OBJECTIVES: Primary * Determine the 3-year progression-free survival of patients with progressive or recurrent Hodgkin's lymphoma treated with tandem autologous stem cell transplantation (2 courses ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00265889
Start Date
February 1 2002
End Date
April 1 2010
Last Update
November 20 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195