|
BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma Clinical research trials and BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma. BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma clinical trial. Subjects often receive the most expert healthcare possible for their BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "B" Clinical Trials Conditions > BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma  BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma
BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma
For Condition: recurrent grade III follicular large cell lymphoma,recurrent adult diffuse large cell lymphoma,recurrent adult lymphoblastic lymphoma,recurrent adult diffuse mixed cell lymphoma,recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma,recurrent adult immunoblastic large cell lymphoma,recurrent mantle cell lymphoma
Status: Suspended
Sponsor(s): Theradex ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RasimGucalp, Study Chair, Montefiore Medical Center
North Shore University Hospital
Manhasset, New York, 11030
United States
West Clinic
Memphis, Tennessee, 38120
United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
Albert Einstein Clinical Cancer Center
Bronx, New York, 10461
United States
Mount Sinai Comprehensive Cancer Center
Miami, Florida, 33140
United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109
United States
HemOnCare, P.C.
Brooklyn, New York, 11235
United States
New York Medical College
Valhalla, New York, 10595
United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71101
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-3596
United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
St. Paul's Hospital - Vancouver
Vancouver, British Columbia, V6Z 1Y6
Canada
Additional Information:
Study ID Numbers: CDR0000069358; THERADEX-100389,SUNY-HSC-4553,BAYER-100389
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039156
Other Recurrent Adult Diffuse Large Cell Lymphoma Studies:
1. Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
2. Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Refractory Non-Hodgkin's Lymphoma, Hodgkin's Disease, or Multiple Myeloma
3. Rituximab and Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
4. Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia
5. Combination Chemotherapy and Radiation Therapy Plus Bone Marrow Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Related Studies:
Other recurrent adult diffuse large cell lymphoma Clinical Trials
Other New York Clinical Trials
Other Valhalla Clinical Trials
BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma
|
|
|
|
|
|
|
|
