Clinical trial NCT00238433
Conditions: Lymphoma
Keywords: recurrent adult Hodgkin lymphoma recurrent adult diffuse small cleaved cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage IV adult diffuse small cleaved cell lymphoma recurrent grade 3 follicular lymphoma stage III grade 3 follicular lymphoma stage IV grade 3 follicular lymphoma recurrent adult diffuse mixed cell lymphoma stage III adult diffuse mixed cell lymphoma stage IV adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma stage III adult immunoblastic large cell lymphoma stage IV adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma stage III adult lymphoblastic lymphoma stage IV adult lymphoblastic lymphoma recurrent adult Burkitt lymphoma stage III adult Burkitt lymphoma stage IV adult Burkitt lymphoma recurrent mantle cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma recurrent marginal zone lymphoma splenic marginal zone lymphoma recurrent small lymphocytic lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent/refractory childhood Hodgkin lymphoma stage III childhood Hodgkin lymphoma stage IV childhood Hodgkin lymphoma recurrent childhood anaplastic large cell lymphoma stage III childhood anaplastic large cell lymphoma stage IV childhood anaplastic large cell lymphoma childhood grade III lymphomatoid granulomatosis recurrent childhood large cell lymphoma stage III childhood large cell lymphoma stage IV childhood large cell lymphoma recurrent childhood lymphoblastic lymphoma stage III childhood lymphoblastic lymphoma stage IV childhood lymphoblastic lymphoma recurrent childhood small noncleaved cell lymphoma stage III childhood small noncleaved cell lymphoma stage IV childhood small noncleaved cell lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma
Sponsor: OHSU Knight Cancer Institute
Start date: 2005-03-01; Completion date: 2016-12-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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 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.

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) 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.

Arms: arm 1: Biological/Vaccine: filgrastim

5mcg/kg intravenous piggyback (IVPB) will be administered beginning on day +5 and continued until absolute neutrophil count (ANC) \> 1500 for 2 consecutive days.

Drug: busulfan

3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.

Drug: melphalan

50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.

Drug: thiotepa

250 mg/m2/day/iv on days -3 and -2 Procedure/Surgery: bone marrow ablation with stem cell support

The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.

Procedure/Surgery: peripheral blood stem cell transplantation

Performed 36-48 hours following last chemotherapy dose.
Interventions: intervention 1: filgrastim intervention 2: busulfan intervention 3: melphalan intervention 4: thiotepa intervention 5: bone marrow ablation with stem cell support intervention 6: peripheral blood stem cell transplantation
Intervention descriptions: intervention 1: 5mcg/kg IVPB will be administered beginning on day +5 and continued until ANC\> 1500 for 2 consecutive days. intervention 2: 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours. intervention 3: 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml. intervention 4: 250 mg/m2/day/iv on days -3 and -2 intervention 5: The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy. intervention 6: Performed 36-48 hours following last chemotherapy dose.

Protocol documents: