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

Primary Purpose

Lymphoma, B-Cell

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PS341 (Bortezomib)
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, B-Cell focused on measuring Cancer, Relapsed, Refractory, B cell lymphoma, Proteasome Inhibitor, PS-341

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UT MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A (mantle-cell lymphoma)

Arm B (other B-cell lymphomas)

Arm Description

Outcomes

Primary Outcome Measures

Number of Patients with Response to PS-341
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.

Secondary Outcome Measures

Full Information

First Posted
May 31, 2002
Last Updated
October 30, 2018
Sponsor
M.D. Anderson Cancer Center
Collaborators
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00038571
Brief Title
Proteasome Inhibitor PS-341 Relapsed or Refractory B Cell Lymphomas Previously Treated With Chemotherapy
Official Title
Phase II Study of Proteasome Inhibitor PS-341 For Patients With Relapsed or Refractory B Cell Lymphomas Previously Treated With Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
Millennium Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, B-Cell
Keywords
Cancer, Relapsed, Refractory, B cell lymphoma, Proteasome Inhibitor, PS-341

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A (mantle-cell lymphoma)
Arm Type
Experimental
Arm Title
Arm B (other B-cell lymphomas)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PS341 (Bortezomib)
Other Intervention Name(s)
Velcade, LPD-341, MLN341, PS-341
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Patients with Response to PS-341
Description
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.
Time Frame
Every two 21-day cycles

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Fayad, MD
Organizational Affiliation
UT MD Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15613697
Citation
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. doi: 10.1200/JCO.2005.03.108. Epub 2004 Dec 21.
Results Reference
result
Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center website

Learn more about this trial

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

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