Proteasome Inhibitor PS-341 Relapsed or Refractory B Cell Lymphomas Previously Treated With Chemotherapy

This study has been completed.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00038571
First received: May 31, 2002
Last updated: July 27, 2012
Last verified: July 2012

May 31, 2002
July 27, 2012
May 2002
March 2005   (final data collection date for primary outcome measure)
Number of Patients with Response to PS-341 [ Time Frame: Every two 21-day cycles ] [ Designated as safety issue: No ]
Patient response evaluated according to criteria of Cheson et al. Endoscopy obtained every two cycles to evaluate response using Complete Response (CR), Partial Response (PR), Progressive Disease, or Stable Disease.
Not Provided
Complete list of historical versions of study NCT00038571 on ClinicalTrials.gov Archive Site
Not Provided
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Not Provided
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Proteasome Inhibitor PS-341 Relapsed or Refractory B Cell Lymphomas Previously Treated With Chemotherapy
Phase II Study of Proteasome Inhibitor PS-341 For Patients With Relapsed or Refractory B Cell Lymphomas Previously Treated With Chemotherapy

Purpose of Phase II study for B-cell lymphoma using PS341: Evaluate efficacy and toxicity of bortezomib in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.

Patients were stratified, based on preclinical data, into arm A (mantle-cell lymphoma) or arm B (other B-cell lymphomas) without limitation in number of prior therapies. Bortezomib was administered as an intravenous push (1.5 mg/m2) on days 1, 4, 8, and 11 every 21 days for a maximum of six cycles.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma, B-Cell
Drug: PS341 (Bortezomib)
1.5 mg/m2 intravenous (IV) bolus push over 3 to 5 seconds on days 1, 4, 8, and 11, followed by a 10-day rest for a 21-day cycle.
Other Names:
  • Velcade
  • LPD-341
  • MLN341
  • PS-341
  • Experimental: Arm A (mantle-cell lymphoma)
    Intervention: Drug: PS341 (Bortezomib)
  • Experimental: Arm B (other B-cell lymphomas)
    Intervention: Drug: PS341 (Bortezomib)
Goy A, Younes A, McLaughlin P, Pro B, Romaguera JE, Hagemeister F, Fayad L, Dang NH, Samaniego F, Wang M, Broglio K, Samuels B, Gilles F, Sarris AH, Hart S, Trehu E, Schenkein D, Cabanillas F, Rodriguez AM. Phase II study of proteasome inhibitor bortezomib in relapsed or refractory B-cell non-Hodgkin's lymphoma. J Clin Oncol. 2005 Feb 1;23(4):667-75. Epub 2004 Dec 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2005
March 2005   (final data collection date for primary outcome measure)

INCLUSION:

  • Relapsed or Refractory B cell lymphoma.
  • Zubrod status </= 3.
  • Measurable disease.
  • No anti-cancer treatment within past 3 weeks.
  • ANC >= 1500/uL, Plt >/= 50,000, Bilirubin <2 mg/dL, SGPT <2.5xULN, creatinine <2. Patients with ANC>/1000, PLT>/30000 will be eligible if due to massive splenomegaly and/or BM involvement.
  • HIV negative.
  • No active CNS lymphoma.
  • No serious intercurrent illness, active infections or cancer except basal cell carcinoma of the skin or in situ cervical carcinoma.
  • Not eligible for treatment of a higher priority. Patients may be entered before BMT.
  • No pregnancy & age bearing females must be practicing adequate contraception.
  • Age > 16.

EXCLUSION:

  • Patients with platelets <30x10(9)/L within 14 days before enrollment.
  • Patients with ANC<1.0 x10(9)/L within 14 days before enrollment.
  • Patients with peripheral neuropathy >/= grade 3 within 14 days before enrollment.
Both
17 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00038571
ID01-596
Yes
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Millennium Pharmaceuticals, Inc.
Principal Investigator: Luis Fayad, MD UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP