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

NCT ID: NCT00039156

Last Updated: 2008-07-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31

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.

Conditions

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

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

ortataxel

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Theradex

INDUSTRY

Sponsor Role: lead

Principal Investigators

Rasim Ahmet Gucalp, MD

Role: STUDY_CHAIR

Montefiore Medical Center

Locations

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Veterans Affairs Medical Center - Shreveport

Shreveport, Louisiana, United States

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, United States

Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

HemOnCare, P.C.

Brooklyn, New York, United States

North Shore University Hospital

Manhasset, New York, United States

State University of New York - Upstate Medical University

Syracuse, New York, United States

Albert Einstein Clinical Cancer Center

The Bronx, New York, United States

New York Medical College

Valhalla, New York, United States

West Clinic

Memphis, Tennessee, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Cross Cancer Institute

Edmonton, Alberta, Canada

St. Paul's Hospital - Vancouver

Vancouver, British Columbia, Canada

Countries

United States; Canada

Other Identifiers

THERADEX-100389

Identifier Type: -

Identifier Source: secondary_id

BAYER-100389

Identifier Type: -

Identifier Source: secondary_id

SUNY-HSC-4553

Identifier Type: -

Identifier Source: secondary_id

CDR0000069358

Identifier Type: -

Identifier Source: org_study_id