Phase II Study of Proteasome Inhibitor PS-341 For Patients With Relapsed or Refractory B Cell Lymphomas Previously Treated With Chemotherapy

This study has been terminated.

First Received: May 31, 2002 Last Updated: August 11, 2005 History of Changes

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00038571

Purpose

Phase II study for B-cell lymphoma using PS341.

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

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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:

Estimated Enrollment:	70
Study Start Date:	May 2002

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. Pts 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
MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Luis Fayad, MD

UT MD Anderson Cancer Center

More Information

No publications provided

Study ID Numbers:	ID01-596
Study First Received:	May 31, 2002
Last Updated:	August 11, 2005
ClinicalTrials.gov Identifier:	NCT00038571 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Bortezomib
Enzyme Inhibitors
Pharmacologic Actions

Protease Inhibitors
Lymphoma, B-Cell
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on November 09, 2009