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

Lymphoma, B-Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00038571
• Other study ID #: ID01-596
• Status: Completed
• Phase: Phase 2
• Start date: May 2002
• Est. completion date: March 2005

Study information

• Verified date: October 2018
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell

Intervention

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.

Locations

Country	Name	City	State
United States	UT MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 bortezomi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Every two 21-day cycles

External Links

•   UT MD Anderson Cancer Center website