Non Hodgkin Lymphoma Clinical Trial
Busulfan, Melphalan, and Thiotepa in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Hodgkin’s or Non-Hodgkin’s Lymphoma
Summary
RATIONALE: Chemotherapy, such as busulfan, melphalan, and thiotepa, may destroy cancerous blood-forming cells (stem cells) in the blood and bone marrow. Giving the patient their healthy stem cells will help their bone marrow make new stem cells that become red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying how well busulfan, melphalan, and thiotepa work in treating patients who are undergoing an autologous stem cell transplant for Hodgkin's or non-Hodgkin's lymphoma.
Full Description
OBJECTIVES:
Determine the therapeutic efficacy of a myeloablative preparative regimen comprising busulfan, melphalan, and thiotepa followed by autologous peripheral blood stem cell (PBSC) transplantation in patients with Hodgkin's or non-Hodgkin's lymphoma.
Determine the toxic effects of this preparative regimen in these patients.
OUTLINE:
Myeloablative preparative regimen: Patients receive busulfan IV over 3 hours on days -8 to -6, melphalan IV over 15-30 minutes on days -5 and -4, and thiotepa IV over 2 hours on days -3 and -2.
Peripheral blood stem cell (PBSC) transplantation: Patients undergo PBSC transplantation on day 0 followed by filgrastim (G-CSF) IV over 30 minutes beginning on day 5 and continuing until blood counts recover.
Intrathecal chemotherapy: Patients with a history of treated Central Nervous System (CNS) disease or at high-risk for CNS relapse receive methotrexate and cytarabine intrathecally (IT) for 2 doses each within 10 days prior to transplantation and 4-6 doses each beginning on day 32 post-transplantation.
Consolidation therapy: Patients with residual bulk disease at 80-100 days post-transplantation that is > 2.5 cm by CT scan may undergo local radiotherapy to residual scar/disease provided it can be encompassed in a single radiation port and the volume of lung to be irradiated is ≤ 20%.
After completion of study treatment, patients are followed weekly for 1 month, monthly for 6 months, every 3 months for 6 months, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Intermediate- or high-grade non-Hodgkin's lymphoma (NHL), meeting 1 of the following criteria:
In first complete remission (CR) AND at high-risk for relapse, as defined by all of the following criteria:
High age-adjusted International Prognostic Index category AND meets the following criteria at diagnosis:
Stage III or IV disease
Lactic dehydrogenase abnormal
Eastern Cooperative Oncology Group (ECOG) score 0-2
Mantle cell histology
Primary refractory disease
Beyond first CR
Low-grade NHL
Beyond second relapse
Hodgkin's lymphoma
Primary refractory disease OR beyond first CR
Must have an adequate number of stored autologous peripheral blood stem cells (PBSCs) (i.e., 2.0 x 10^6 hematopoietic progenitor cell antigen (CD34)-positive cells/kg)
Patients who are not able to mobilize a sufficient number of PBSCs may use bone marrow instead
No active CNS disease NOTE: 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
0 to 70
Performance status
ECOG 0-2
Life expectancy
Not specified
Hematopoietic
Not specified
Hepatic
Bilirubin < 2 times upper limit of normal (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times ULN
Renal
Creatinine ≤ 2.0 mg/dL
Creatinine clearance ≥ 50 mL/min
Pulmonary
No significant pulmonary dysfunction, defined as Diffusing Capacity the Lung for Carbon monoxide (DLCO) < 60% of predicted
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception for ≥ 2 months before and during study participation
HIV negative
No significant active infection that would preclude PBSC transplantation
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior transplantation
No other concurrent blood products during PBSC transplantation
Chemotherapy
Not specified
Endocrine therapy
Not specified
Radiotherapy
More than 60 days since prior local or regional radiotherapy
Surgery
Not specified
Other
More than 30 days since prior investigational drugs
No concurrent amphotericin
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There is 1 Location for this study
Portland Oregon, 97239, United States
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