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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00039156
First received: June 6, 2002
Last updated: July 23, 2008
Last verified: January 2004
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: ortataxel
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Phase II Multi-Center Trial of BAY 59-8862 in Patients With Aggressive Refractory Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: January 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00039156

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00039156     History of Changes
Other Study ID Numbers: CDR0000069358, THERADEX-100389, BAYER-100389, SUNY-HSC-4553
Study First Received: June 6, 2002
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent grade 3 follicular lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
recurrent mantle cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 23, 2014