BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma

July 23, 2008 updated by: Theradex

An Open Phase II Multi-Center Trial of BAY 59-8862 in Patients With Aggressive Refractory Non-Hodgkin's Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who have refractory non-Hodgkin's lymphoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the overall tumor response rate, including complete response (CR) and partial response (PR) rate, in patients with aggressive refractory non-Hodgkin's lymphoma treated with BAY 59-8862.
  • Determine the overall survival in patients treated with this drug.
  • Determine the time to progression in patients treated with this drug.
  • Determine the duration of response (CR and PR) in patients treated with this drug.
  • Determine the qualitative and quantitative toxicity profile of this drug in this patient population.
  • Determine the pharmacokinetic profile of this drug in selected patients.

OUTLINE: This is a multicenter, open-label study.

Patients receive BAY 59-8862 IV over 1 hour on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression and then every 6 months thereafter for up to 2 years.

PROJECTED ACCRUAL: A total of 20-140 patients will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital - Vancouver
  • United States
    • Florida
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Comprehensive Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
    • Louisiana
      • Shreveport, Louisiana, United States, 71130-3932
        • Louisiana State University Health Sciences Center - Shreveport
      • Shreveport, Louisiana, United States, 71101
        • Veterans Affairs Medical Center - Shreveport
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Cancer Institute of New Jersey
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein Clinical Cancer Center
      • Brooklyn, New York, United States, 11235
        • HemOnCare, P.C.
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • Syracuse, New York, United States, 13210
        • State University of New York - Upstate Medical University
      • Valhalla, New York, United States, 10595
        • New York Medical College
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • West Clinic
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226-3596
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed aggressive refractory non-Hodgkin's lymphoma (NHL) of one of the following classifications, and for which chemotherapy is deemed appropriate:

    • Diffuse large B-cell lymphoma
    • Transformed NHL
    • Follicular large cell lymphoma
    • Peripheral T cell lymphoma
    • Anaplastic large cell lymphoma
    • Mantle cell lymphoma
    • Unclassified aggressive histology
    • Immunoblastic lymphoma
  • Failed at least 1 prior therapy (primary resistant) OR
  • Previously achieved a remission and then progressed or relapsed within 6 months of therapy

  • At least 1 bidimensionally measurable lesion

    • Lesions within a previously irradiated field are not considered measurable
  • No relapse within 6 months after prior autologous bone marrow transplantation
  • No prior allogeneic bone marrow or stem cell transplantation or post-transplant lymphoproliferative disorder
  • No parenchymal or meningeal CNS involvement unless the patient received prior definitive therapy more than 6 months ago, has had a negative imaging study within the past 4 weeks, and is clinically stable with respect to the tumor at study entry

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 75,000/mm^3
  • Hemoglobin at least 9.0 g/dL

Hepatic:

  • Total bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • ALT and AST no greater than 2.0 times ULN (5.0 times ULN if hepatic involvement)
  • PT, INR, and PTT less than 1.5 times ULN
  • No chronic hepatitis B or C

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No clinically evident congestive heart failure
  • No New York Heart Association class III or IV heart disease
  • No serious cardiac arrhythmias
  • No active coronary artery disease or ischemia

Other:

  • No prior hypersensitivity to taxane compounds
  • No known or suspected allergy to the investigational study agent or any agent given in association with this study
  • No other prior or concurrent malignancy except basal cell skin cancer or curatively treated carcinoma in situ of the bladder or cervix (adequately cone biopsied)
  • No substance abuse or medical, psychological, or social conditions that would preclude study participation
  • No active clinically serious infections
  • No other condition that is unstable or would preclude study participation
  • No grade 2 or greater pre-existing peripheral neuropathy

  • No history of seizure disorder

    • Prior seizures related to brain metastases allowed provided that the patient has been seizure-free for at least 2 months
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • See Chemotherapy
  • At least 4 weeks since prior anticancer immunotherapy
  • At least 3 weeks since prior biologic response modifiers (e.g., filgrastim [G-CSF])
  • No concurrent anticancer immunotherapy
  • No concurrent prophylactic G-CSF
  • Concurrent G-CSF or other hematopoietic growth factors for acute toxicity (e.g., febrile neutropenia) allowed
  • Concurrent chronic epoetin alfa allowed provided no dose adjustment occurred within 2 months prior to study

Chemotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior anticancer chemotherapy

  • No more than 3 prior systemic chemotherapy regimens for metastatic NHL:

    • High-dose therapy for autologous hematopoietic stem cell transplantation (SCT) is considered 1 prior regimen
    • Salvage chemotherapy followed by autologous bone marrow transplant or peripheral SCT is considered 1 prior regimen
    • Antibody treatment is not considered 1 prior regimen
  • No prior taxanes or oxaliplatin
  • No other concurrent anticancer chemotherapy

Endocrine therapy:

  • Patients with prior parenchymal or meningeal CNS involvement:

    • No concurrent acute or tapered steroid therapy
    • Concurrent chronic steroid therapy allowed provided the dose is stable for 1 month before and after screening radiographic studies

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy

  • Concurrent palliative radiotherapy allowed provided:

    • No progressive disease
    • No more than 10% of bone marrow is irradiated
    • Radiation field does not encompass a target lesion
  • No other concurrent radiotherapy

Surgery:

  • At least 4 weeks since prior major surgery

Other:

  • At least 4 weeks since prior investigational drugs
  • No other concurrent investigational therapy or approved anticancer therapy
  • No concurrent illicit drugs or other substances that would preclude study
  • Concurrent therapeutic anticoagulants (e.g., warfarin or heparin) allowed provided there is no prior evidence of underlying abnormality with PT, INR, or PTT
  • Concurrent nonconventional therapies (e.g., herbs or acupuncture) or vitamin/mineral supplements allowed provided that they do not interfere with study endpoints
  • Concurrent bisphosphonates for prophylaxis or bone metastases allowed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theradex

Investigators

  • Study Chair: Rasim Ahmet Gucalp, MD, Montefiore Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Study Registration Dates

First Submitted

June 6, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 24, 2008

Last Update Submitted That Met QC Criteria

July 23, 2008

Last Verified

January 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069358
  • THERADEX-100389
  • BAYER-100389
  • SUNY-HSC-4553

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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