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

This study has been completed.
Sponsor:
Information provided by:
Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT00636311
First received: March 11, 2008
Last updated: September 1, 2010
Last verified: September 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

Enrollment: 13
Study Start Date: February 2008
Study Completion Date: February 2010
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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.
Experimental: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636311

Locations
Italy
Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
  More Information

Publications:
Responsible Party: Armando Santoro, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT00636311     History of Changes
Other Study ID Numbers: ONC-2006-005, EUDRACT 2007-004883-29
Study First Received: March 11, 2008
Last Updated: September 1, 2010
Health Authority: Italy: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 26, 2014