Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Poor Risk Recurrent Hodgkin's Disease
18 Years
N/A
Both
Lymphoma
Trial Information
Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Poor Risk Recurrent Hodgkin's Disease
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 of high-dose therapy with autologous stem cell rescue).
- Determine the response rate in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
OUTLINE: This is a pilot study. Patients are stratified according to risk (poor risk
[primary progressive, recurrent, or resistant relapse] vs good risk [first recurrence]).
- Salvage therapy (for patients with relapsed disease after achieving a previous complete
response): Patients receive at least 2 courses of salvage chemotherapy or radiotherapy.
- Autologous hematopoietic stem cell collection: Patients undergo autologous
hematopoietic stem cell collection. Patients with an inadequate number of collected
stem cells are removed from the study.
- First preparative regimen: Patients receive high-dose melphalan IV continuously over 16
hours on day -1.
- First autologous stem cell transplantation (SCT): Patients undergo autologous SCT on
day 0. They also receive filgrastim (G-CSF) IV over 30 minutes once daily beginning on
day 5 and continuing until blood counts recover. At least 4-8 weeks later, patients
proceed to second preparative regimen.
- Second preparative regimen: Patients receive high-dose carmustine IV over 1-2 hours on
days -6, -5, and -4, etoposide IV over 4 hours on day -3, and cyclophosphamide IV over
2 hours on day -2. Beginning 36-48 hours later, patients proceed to the second
autologous SCT (day 0).
- Second autologous SCT: Patients undergo second autologous SCT on day 0. Patients also
receive filgrastim (G-CSF) IV over 30 minutes once daily beginning on day 5 and
continuing until blood counts recover.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.
Inclusion 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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival at 3 years
Outcome Time Frame:
Up to three years after second transplant
Safety Issue:
No
Principal Investigator
Brian J. Bolwell, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Cleveland Clinic Taussig Cancer Institute
Authority:
United States: Institutional Review Board
Study ID:
CCF5386
NCT ID:
NCT00265889
Start Date:
February 2002
Completion Date:
Related Keywords:
- Lymphoma
- recurrent adult Hodgkin lymphoma
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- Hodgkin Disease
- Lymphoma
Name | Location |
|---|---|
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland, Ohio 44195 |
