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

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Millennium Pharmaceuticals, Inc.
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00038571

Purpose

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.

Condition	Intervention	Phase
Lymphoma, B-Cell	Drug: PS341 (Bortezomib)	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Study of Proteasome Inhibitor PS-341 For Patients With Relapsed or Refractory B Cell Lymphomas Previously Treated With Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Bortezomib

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

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.

Enrollment:	60
Study Start Date:	May 2002
Study Completion Date:	March 2005
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm A (mantle-cell lymphoma)	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 B (other B-cell lymphomas)	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

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.

Eligibility

Ages Eligible for Study:	17 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038571

Locations

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Millennium Pharmaceuticals, Inc.

Investigators

Principal Investigator:

Luis Fayad, MD

UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	Luis E.Fayad, MD / Associate Professor, UT MD Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00038571 History of Changes
Other Study ID Numbers:	ID01-596
Study First Received:	May 31, 2002
Last Updated:	October 21, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Cancer
Relapsed
Refractory

B cell lymphoma
Proteasome Inhibitor
PS-341

Additional relevant MeSH terms:

Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

Lymphoma, Non-Hodgkin
Bortezomib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 13, 2012