Ph II CHOP+Velcade in Mediastinal LBCL

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT00361621
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bortezomib — DRUG
    Given intravenously on day 1 and day 4 of a 21-day cycle for 6 cycles
  • 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

Study Details

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.

Key Dates

Start date
Jul 31, 2006
Status verified
Oct 2009
Primary completion
Nov 30, 2007
Completion
May 31, 2008

Study Design

Enrollment
3 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

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. [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02115-

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Dana Farber Cancer Institute· Boston, MA

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