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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Theradex
• Treatments: IDN 5109

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