Autologous Stem Cell Transplant in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma
NCT ID: NCT00265889
Last Updated: 2013-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
42 participants
INTERVENTIONAL
2002-02-28
2010-04-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Poor Risk
Primary progressive, recurrent, or resistant relapse patients
filgrastim
480 mcg beginning day +5
busulfan
11.2 mg/kg; 0.8 mg/kg IV q6h X 14 doses
cyclophosphamide
60 mg/kg IV over 2 hours x 2 days
etoposide
60 mg/kg, IV
melphalan
150mg/m2 in NS at a concentration of 0.4mg/cc infused over 60 minutes.
autologous-autologous tandem hematopoietic stem cell transplantation
autologous-autologous tandem hematopoietic stem cell transplantation
radiation therapy
radiation therapy
Good Risk
First recurrence patients
filgrastim
480 mcg beginning day +5
busulfan
11.2 mg/kg; 0.8 mg/kg IV q6h X 14 doses
cyclophosphamide
60 mg/kg IV over 2 hours x 2 days
etoposide
60 mg/kg, IV
melphalan
150mg/m2 in NS at a concentration of 0.4mg/cc infused over 60 minutes.
autologous-autologous tandem hematopoietic stem cell transplantation
autologous-autologous tandem hematopoietic stem cell transplantation
radiation therapy
radiation therapy
Interventions
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filgrastim
480 mcg beginning day +5
busulfan
11.2 mg/kg; 0.8 mg/kg IV q6h X 14 doses
cyclophosphamide
60 mg/kg IV over 2 hours x 2 days
etoposide
60 mg/kg, IV
melphalan
150mg/m2 in NS at a concentration of 0.4mg/cc infused over 60 minutes.
autologous-autologous tandem hematopoietic stem cell transplantation
autologous-autologous tandem hematopoietic stem cell transplantation
radiation therapy
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Brian J. Bolwell, MD
Role: STUDY_CHAIR
Cleveland Clinic Taussig Cancer Institute
Locations
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Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CCF-5386
Identifier Type: OTHER
Identifier Source: secondary_id
CCF5386
Identifier Type: -
Identifier Source: org_study_id