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NCT Number: NCT00038571

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

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.

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Key information

Conditions

Lymphoma, B-Cell Disease Attributes Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PS341 (Bortezomib)

Drug

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

Primary outcomes

  1. Number of Patients with Response to PS-341

    Time frame: Every two 21-day cycles

    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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • Millennium Pharmaceuticals, Inc.

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Jun 3, 2002
Registry last updated
Oct 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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