Status:
COMPLETED
Busulfan, Melphalan, and Thiotepa in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Hodgkin's or Non-Hodgkin's Lymphoma
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
Up to 70 years
Phase:
PHASE2
Brief 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 wil...
Detailed Description
OBJECTIVES: * Determine the therapeutic efficacy of a myeloablative preparative regimen comprising busulfan, melphalan, and thiotepa followed by autologous peripheral blood stem cell (PBSC) transplan...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00238433
Start Date
March 1 2005
End Date
December 1 2016
Last Update
September 27 2017
Active Locations (1)
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1
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098