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

NCT00039156 | Unknown Phase 2

• 4 other identifiers: CDR0000069358THERADEX-100389BAYER-100389SUNY-HSC-4553
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 15

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.

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

Interventions

ortataxel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Theradex: lead

Study Sites (15)

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Veterans Affairs Medical Center - Shreveport

Shreveport, Louisiana, 71101, United States

Location

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, 71130-3932, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

HemOnCare, P.C.

Brooklyn, New York, 11235, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

State University of New York - Upstate Medical University

Syracuse, New York, 13210, United States

Location

Albert Einstein Clinical Cancer Center

The Bronx, New York, 10461, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

West Clinic

Memphis, Tennessee, 38120, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226-3596, United States

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

St. Paul's Hospital - Vancouver

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Immunoblastic; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Burkitt Lymphoma; Lymphoma, Mantle-Cell

Interventions

IDN 5109

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Study Officials

• Rasim Ahmet Gucalp, MD

  Montefiore Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 6, 2002
• First Posted: January 27, 2003
• Study Start: January 1, 2002
• Last Updated: July 24, 2008

Record last verified: 2004-01

Locations

US (13); CA (2)