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


Phase 2
17 Years
N/A
Not Enrolling
Both
Lymphoma, B-Cell

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Trial Information

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


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.

Inclusion Criteria


INCLUSION:

- Relapsed or Refractory B cell lymphoma.

- Zubrod status
- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients with Response to PS-341

Outcome 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.

Outcome Time Frame:

Every two 21-day cycles

Safety Issue:

No

Principal Investigator

Luis Fayad, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

ID01-596

NCT ID:

NCT00038571

Start Date:

May 2002

Completion Date:

March 2005

Related Keywords:

  • Lymphoma, B-Cell
  • Cancer
  • Relapsed
  • Refractory
  • B cell lymphoma
  • Proteasome Inhibitor
  • PS-341
  • Lymphoma
  • Lymphoma, B-Cell

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030