Status:
COMPLETED
Melphalan, Yttrium Y 90 Ibritumomab Tiuxetan, and Rituximab Followed by Autologous Stem Cell Transplant in Treating Older Patients With Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment
Lead Sponsor:
Swiss Cancer Institute
Conditions:
Lymphoma
Eligibility:
All Genders
65-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Giving chemotherapy drugs, such as melphalan, before an autologous stem cell transplant helps stop the growth of cancer cells, either by killing the cells or by stopping them from dividing....
Detailed Description
OBJECTIVES: * Determine the maximum tolerated dose of high-dose melphalan when given together with yttrium Y 90 ibritumomab tiuxetan and rituximab as a conditioning regimen followed by vinorelbine di...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed non-Hodgkin's lymphoma of any type
- CD20-positive disease
- Achieved partial or complete response to salvage treatment for relapse or refractory disease within the past 10 weeks
- Must have an indication for autologous stem cell transplantation
- Bone marrow infiltration \< 25%
- No evidence of CNS involvement
- PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2 times ULN
- AST ≤ 2 times ULN
- Creatinine clearance \> 50 mL/min
- No clinically significant cardiac disease, including any of the following:
- Unstable angina pectoris
- Significant arrhythmia
- Myocardial infarction within the past 3 months
- LVEF \> 50%
- No clinically significant urinary tract obstruction
- No clinically significant pulmonary disease
- No serious underlying medical condition that would preclude study participation
- No other malignancy within the past 5 years except nonmelanoma skin cancer or adequately treated in situ cervical cancer
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 30 days since prior participation in another clinical trial
- No prior stem cell transplantation
- No prior radiolabeled antibodies, including for induction of disease remission
- No prior radiotherapy to ≥ 25% of the bone marrow
- No concurrent radiotherapy
- No other concurrent anticancer drugs
- No other concurrent investigational drugs
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00392691
Start Date
October 1 2006
End Date
May 1 2013
Last Update
May 15 2019
Active Locations (10)
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1
Kantonsspital Aarau
Aarau, Switzerland, CH-5001
2
Saint Claraspital AG
Basel, Switzerland, 4016
3
Universitaetsspital-Basel
Basel, Switzerland, CH-4031
4
Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli
Bellinzona, Switzerland, 6500