A Phase II Study of IGEV +/- Bortezomib Before Hign Dose Consolidation in Relapsed/Refractory Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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 increases the rate of complete remission (PET negativity) at transplantation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Clinico Humanitas
• Treatments: Bortezomib; Gemcitabine; Ifosfamide; Isophosphamide mustard; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.