Busulfan, Melphalan, and Thiotepa in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Hodgkin's or Non-Hodgkin's Lymphoma
Status: | Completed |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any - 70 |
Updated: | 10/14/2017 |
Start Date: | March 2005 |
End Date: | December 2016 |
A Phase II Study to Evaluate the Safety and Efficacy of IV Busulfan, Melphalan, and Thiotepa (BuMelTT) Followed By Autologous PBSC Infusion for Patients With Hodgkin's Disease and Non-Hodgkin's Lymphoma
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.
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.
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.
- 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.
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
We found this trial at
1
site
Click here to add this to my saved trials