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

Istituto Clinico Humanitas

Status and phase

Completed

Phase 2

Conditions

Hodgkin Disease

Treatments

Drug: Ifosfamide, Gemcitabine, Vinorelbine

Drug: Bortezomib + IGEV

Study type

Interventional

Funder types

Other

Identifiers

NCT00636311

ONC-2006-005

EUDRACT 2007-004883-29

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.