Clinical trial · Interventional
BAY 59-8862 in Treating Patients With Refractory Non-Hodgkin's Lymphoma
An Open Phase II Multi-Center Trial of BAY 59-8862 in Patients With Aggressive Refractory Non-Hodgkin's Lymphoma
NCT00039156CI-TRIAL-00001595unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ortataxel | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.