Status:
COMPLETED
A Phase II Study of IGEV +/- Bortezomib Before Hign Dose Consolidation in Relapsed/Refractory Hodgkin's Lymphoma
Lead Sponsor:
Istituto Clinico Humanitas
Conditions:
Hodgkin Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate if the addition of Bortezomib (Velcade) to IGEV combination (Ifosfamide, Gemcitabine and Vinorelbine) in patients with relapsed/refractory Hodgkin's lymphoma i...
Eligibility Criteria
Inclusion
- Diagnosis of Hodgkin's lymphoma failing or relapsing after first-line chemotherapy (MOPP/AVBD , MOPP/EBV/CAD and analogs are considered one line)
- Age \>18 and \<65 years
- Signed informed consent
- If female, patient is either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control
- If male, patient agrees to use an acceptable barrier method for contraception
- ECOG performance status \<2
- Platelet count \>100.000/mmc
- Hemoglobin \>7.5 g/dL
- Absolute neutrophil count (ANC) \>1.500/mmc
- Serum calcium \<3.5 mmol/L (\<14 mg/dL)
- AST/ALT: \<2.5 x the ULN
- Total bilirubin: \<1.5 x the ULN
Exclusion
- Previous treatment with velcade
- Nitrosoureas within 6 weeks or any other chemotherapy within 3 weeks before enrollment
- Immunotherapy or antibody therapy within 4 weeks before enrollment
- Experimental drug or medical device within 4 weeks before start of treatment
- Major surgery within 4 weeks before enrollment
- History of allergic reaction attributable to compounds containing boron or mannitol or any of the drugs in the IGEV regimen
- Peripheral neuropathy of NCI CTCAE Grade 2 or higher
- Myocardial infarction within 6 months of enrollment or NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances including diabetes mellitus
- Need for therapy with concomitant CYP 3A4 inhibitors or inducers
- HIV-positive, if known
- Hepatitis B surface antigen-positive or active hepatitis C infection, if known
- Active systemic infection requiring treatment
- If female, pregnancy or breast-feeding.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00636311
Start Date
February 1 2008
End Date
February 1 2010
Last Update
September 2 2010
Active Locations (1)
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1
Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089