search
Back to results

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

Primary Purpose

Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ortataxel
Sponsored by
Theradex
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mount Sinai Comprehensive Cancer Center
  • University of Chicago Cancer Research Center
  • Veterans Affairs Medical Center - Shreveport
  • Louisiana State University Health Sciences Center - Shreveport
  • Cancer Institute of New Jersey
  • Albert Einstein Clinical Cancer Center
  • HemOnCare, P.C.
  • North Shore University Hospital
  • State University of New York - Upstate Medical University
  • New York Medical College
  • West Clinic
  • Seattle Cancer Care Alliance
  • Medical College of Wisconsin
  • Cross Cancer Institute
  • St. Paul's Hospital - Vancouver

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 6, 2002
Last Updated
July 23, 2008
Sponsor
Theradex
search

1. Study Identification

Unique Protocol Identification Number
NCT00039156
Brief Title
BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma
Official Title
An Open Phase II Multi-Center Trial of BAY 59-8862 in Patients With Aggressive Refractory Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2004
Overall Recruitment Status
Unknown status
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Theradex

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ortataxel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rasim Ahmet Gucalp, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Veterans Affairs Medical Center - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Louisiana State University Health Sciences Center - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Albert Einstein Clinical Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
HemOnCare, P.C.
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
State University of New York - Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3596
Country
United States
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
St. Paul's Hospital - Vancouver
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs