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A Phase II Study of IGEV +/- Bortezomib Before Hign Dose Consolidation in Relapsed/Refractory Hodgkin's Lymphoma
This study is currently recruiting participants.
Verified by Istituto Clinico Humanitas, August 2008
First Received: March 11, 2008   Last Updated: January 29, 2009   History of Changes
Sponsored by: Istituto Clinico Humanitas
Information provided by: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT00636311
  Purpose

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.


Condition Intervention Phase
Hodgkin Disease
Drug: Ifosfamide, Gemcitabine, Vinorelbine
Drug: Bortezomib + IGEV
Phase II

MedlinePlus related topics: Hodgkin's Disease Lymphoma
Drug Information available for: Vinorelbine Gemcitabine Gemcitabine hydrochloride Vinorelbine tartrate Bortezomib Ifosfamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: IGEV +/- Bortezomib (Velcade) as Induction Before High Dose Consolidation in Relapsed/Refractory Hodgkin's Lymphoma After First Line Treatment: a Randomized Phase II Trial. On Behalf of Intergruppo Italiano Linfomi

Further study details as provided by Istituto Clinico Humanitas:

Primary Outcome Measures:
  • PET negativity rate obtained with IGEV or B-IGEV will be compared [ Time Frame: PET negativity after 4 courses of induction (IGEV or B-IGEV) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: February 2008
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
IGEV regimen (Ifosfamide, Gemcitabine, Vinorelbine)
Drug: Ifosfamide, Gemcitabine, Vinorelbine
Ifosfamide 2000 mg/sqm, day 1-4 (plus MESNA); Gemcitabine 800 mg/sqm, day 1 and 4; Vinorelbine 20 mg/sqm, day 1; Prednisone 100 mg, day 1-4; G-CSF 1 vial sc, day 7-12 of each 21-day course.
2: Experimental
B-IGEV (Bortezomib + IGEV)
Drug: Bortezomib + IGEV
Bortezomib 1,3 mg/sqm, day 1, 4, 8; Ifosfamide 2000 mg/sqm, day 1-4 (plus MESNA); Gemcitabine 800 mg/sqm, day 1 and 4; Vinorelbine 20 mg/sqm, day 1; Prednisone 100 mg, day 1-4; G-CSF 1 vial sc, day 7-12 of each 21-day course.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636311

Contacts
Contact: Armando Santoro, MD +39 02 8224 ext 4080 armando.santoro@humanitas.it
Contact: Monica Balzarotti, MD +39 02 8224 ext 4536 monica.balzarotti@humanitas.it

Locations
Italy, Milan
Istituto Clinico Humanitas Recruiting
Rozzano, Milan, Italy, 20089
Contact: Armando Santoro, MD     +39 02 8224 ext 4080     armando.santoro@humanitas.it    
Contact: Monica Balzarotti, MD     +39 02 8224 ext 4536     monica@balzarotti@humanitas.it    
Sub-Investigator: Monica Balzarotti, MD            
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
  More Information

Publications:
Responsible Party: Istituto Clinico Humanitas ( Armando Santoro, MD )
Study ID Numbers: ONC-2006-005, EUDRACT 2007-004883-29
Study First Received: March 11, 2008
Last Updated: January 29, 2009
ClinicalTrials.gov Identifier: NCT00636311     History of Changes
Health Authority: Italy: Ministry of Health

Keywords provided by Istituto Clinico Humanitas:
Hodgkin disease
Salvage therapy
Bortezomib
Transplantation

Study placed in the following topic categories:
Antimetabolites
Prednisone
Immunoproliferative Disorders
Immunologic Factors
Hodgkin Lymphoma, Adult
Bortezomib
Hodgkin's Disease
Immunosuppressive Agents
Antiviral Agents
Protease Inhibitors
Lymphatic Diseases
Ifosfamide
Vinorelbine
Radiation-Sensitizing Agents
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders
Gemcitabine
Antineoplastic Agents, Phytogenic
Alkylating Agents
Mesna
Lymphoma
Hodgkin Disease
Isophosphamide mustard

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Therapeutic Uses
Gemcitabine
Lymphoma
Hodgkin Disease
Alkylating Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Bortezomib
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Protease Inhibitors
Lymphatic Diseases
Ifosfamide
Neoplasms
Vinorelbine
Radiation-Sensitizing Agents
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 07, 2009