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

Tracking Information

First Received Date ^ICMJE

May 31, 2002

Last Updated Date

August 11, 2005

Start Date ^ICMJE

May 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00038571 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Brief Summary

Phase II study for B-cell lymphoma using PS341.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Lymphoma, B-Cell

Intervention ^ICMJE

Drug: PS341

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

17 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00038571

Responsible Party

Study ID Numbers ^ICMJE

ID01-596

Study Sponsor ^ICMJE

M.D. Anderson Cancer Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Luis Fayad, MD

UT MD Anderson Cancer Center

Information Provided By

M.D. Anderson Cancer Center

Verification Date

August 2005

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