Phase II Study of "VIPER" Chemotherapy in Rel/Ref DLBCL

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT00504751
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • bortezomib, dexamethasone, ifosfamide — DRUG
    VIPER chemotherapy will be administered every 28 days at the following doses: * Dexamethasone 40 mg IV days 1-4 * Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4 * Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide) * Cisplatin 25 mg IV days 1-4 * Etoposide 100 mg/m2 CIVI over 24 hours days 1-4 * Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles) * VELCADE 1.5 mg/m2 on days 2 and 5
  • mesna, cisplatin, etoposide, rituximab — DRUG
    VIPER chemotherapy will be administered every 28 days at the following doses: * Dexamethasone 40 mg IV days 1-4 * Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4 * Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide) * Cisplatin 25 mg IV days 1-4 * Etoposide 100 mg/m2 CIVI over 24 hours days 1-4 * Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles) * VELCADE 1.5 mg/m2 on days 2 and 5

Study Details

Objectives The primary objective of this study is to: • determine the complete and partial response rates and the toxicity profile of bortezomib (VELCADE, formerly PS-341) when administered in combination with DICE chemotherapy plus rituximab (i.e. VIPER) to patients with relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma The secondary objectives of this study are to: * assess event free survival and overall survival * assess conversion of chemo-resistant to chemo-sensitive disease * assess the ability to collect stem cells from patients treated with salvage VIPER who then undergo autologous stem cell transplantation * perform correlative studies on pre-treatment tumor biopsy specimens; analyses will include the assessment of immunohistochemical expression patterns (germinal center B cell vs. activated B cell) and NF-κB activity

Key Dates

Start date
May 31, 2007
Status verified
Feb 2017
Primary completion
Dec 31, 2010
Completion
Feb 17, 2012

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Study Treatment
    This is a single arm study

Primary Outcome Measure

Complete Response [ Time Frame: 26 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell Medical CollegeNew YorkNew York10021-

Find similar trials in New York, NY

By research site
Weill Cornell Medical College· New York, NY

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