Overview

This trial is active, not recruiting.

Condition lymphoma
Treatments filgrastim, busulfan, melphalan, thiotepa, bone marrow ablation with stem cell support, peripheral blood stem cell transplantation
Phase phase 2
Sponsor OHSU Knight Cancer Institute
Collaborator National Cancer Institute (NCI)
Start date March 2005
End date January 2014
Trial size 37 participants
Trial identifier NCT00238433, CDR0000446086, OHSU-HEM-04083-L, OHSU-IRB-248, P30CA069533

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Biological/Vaccine: filgrastim 5mcg/kg IVPB will be administered beginning on day +5 and continued until 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.
filgrastim
5mcg/kg IVPB will be administered beginning on day +5 and continued until ANC> 1500 for 2 consecutive days.
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.
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.
thiotepa
250 mg/m2/day/iv on days -3 and -2
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.
peripheral blood stem cell transplantation
Performed 36-48 hours following last chemotherapy dose.

Primary Outcomes

Measure
Disease-free survival at 3, 6, 9, 12, 18, and 24 months post transplantation
time frame: 3, 6, 9, 12, 18, and 24 months post transplantation
Regimen-related toxicity through 24 months post transplantation
time frame: Through 24 months post transplantation

Eligibility Criteria

Male or female participants up to 70 years old.

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 - ECOG 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 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) - AST and ALT < 3 times ULN Renal - Creatinine ≤ 2.0 mg/dL - Creatinine clearance ≥ 50 mL/min Pulmonary - No significant pulmonary dysfunction, defined as 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

Additional Information

Official title 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
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by OHSU Knight Cancer Institute.