Ph II CHOP+Velcade in Mediastinal LBCL

NCT00361621 | Terminated Phase 2

• 2 other identifiers: 06-012X05194
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to begin to collect information and try to learn whether or not VELCADE, when added to standard chemotherapy with CHOP/Rituxan, works in treating patients mediastinal large B-cell lymphoma. Recent research has shown that this type of lymphoma shares features with Hodgkin's lymphoma, including the importance of a particular pathway in the tumor cells called the NF-kB pathway. VELCADE works in part by blocking this pathway.

Conditions

Non-Hodgkin's Lymphoma

Keywords

VELCADE

Outcome Measures

Primary Outcomes (1)

• To evaluate the rate of complete response to therapy defined as resolution of PET avidity in all previously documented sites at the completion of chemotherapy.

  1 year

Secondary Outcomes (4)

• Assess toxicity

  1 year

• evaluate event-free survival at 2 years

  2 years

• evaluate overall survival at 2 years

  2 years

• assess early PET restaging after 3 cycles of chemotherapy.

  1 year

Interventions

bortezomib DRUG

Given intravenously on day 1 and day 4 of a 21-day cycle for 6 cycles

Also known as: Velcade

Rituximab DRUG

Given intravenously on day 1 of a 21-day cycle for 6 cycles

Cyclophosphamide DRUG

Given intravenously on day 1 of a 21-day cycle for 6 cycles

Doxorubicin DRUG

Given intravenously on day 1 of a 21-day cycle for 6 cycles

Vincristine DRUG

Given intravenously on day 1 of a 21-day cycle for 6 cycles

Prednisone DRUG

Taken orally on days 2, 3, 4 and 5 or a 21-day cycle for 6 cycles

Radiation therapy RADIATION

After 6 cycles of chemotherapy there will be 3 weeks of radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
• Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
• Male subject agrees to use an acceptable method for contraception for the duration of the study.
• Histologic Documentation: Histologically confirmed Primary Mediastinal Large B-cell Lymphoma with confirmatory immunoperoxidase stains including TRAF-1, and nuclear c-rel. All cases must be reviewed at Brigham and Women's Hospital.
• Previously untreated patients with the exception of limited radiotherapy or steroids for SVC syndrome
• Age \> 18 years of age
• Measurable Disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan.

You may not qualify if:

• Patient has a platelet count of \< 100,000/uL within 14 days before enrollment.
• Patient has an absolute neutrophil count of \< 1500/uL within 14 days before enrollment.
• Patient has a calculated or measured creatinine clearance of \<30 mL/minute within 14 days before enrollment.
• Patient has ³Grade 2 peripheral neuropathy within 14 days before enrollment.
• Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
• Patient has hypersensitivity to bortezomib, boron or mannitol.
• Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum b-human chorionic gonadotropin (b-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
• Patient has received other investigational drugs with 14 days before enrollment
• Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
• Patient has a cardiac ejection fraction \< 50% by echocardiogram or MUGA scan

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator
• Millennium Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Bortezomib; Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone; Radiotherapy

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Therapeutics

Study Officials

• Ann LaCasce, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: August 7, 2006
• First Posted: August 8, 2006
• Study Start: July 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: May 1, 2008
• Last Updated: December 3, 2012

Record last verified: 2009-10

Locations

US (1)