Clinical Drug Experience Knowledgebase

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed aggressive non-Hodgkin's lymphoma including:

Peripheral T-cell lymphoma not otherwise specified
Anaplastic large null-/T-cell lymphoma

Diffuse large B-cell lymphoma including:

Primary mediastinal large B-cell lymphoma with sclerosis
Intravascular large B-cell lymphoma
Immunoblastic B-cell lymphoma
T-cell-rich B-cell lymphoma
Anaplastic large B-cell lymphoma
At least one bidimensionally measurable lesion with clearly defined margins at least 2 cm in the largest dimension by physical examination or CT scan
No prior or active CNS lymphoma or AIDS-related lymphoma

Must have received 2 or more prior chemotherapy courses from time of diagnosis of aggressive lymphoma or from time of biopsy-proven transformation from indolent to aggressive

Prior first and second-line therapy must have been combination chemotherapy
Prior first-line chemotherapy regimen must have contained anthracycline
Must have had at least a minor response to first-line therapy

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-3

Life expectancy:

Not specified

Hematopoietic:

Granulocyte count at least 500/mm^3 (unless due to lymphoma bone marrow involvement)
Platelet count at least 50,000/mm^3 (unless due to lymphoma bone marrow involvement)

Hepatic:

Bilirubin no greater than 2 times upper limit of normal (ULN)
ALT no greater than 4 times ULN
Alkaline phosphatase no greater than 4 times ULN

Renal:

Not specified

Neurologic:

No prior neurological disorders unrelated to chemotherapy (including familial neurological diseases or acquired demyelinating disorders)
No neuromuscular impairment (neuromotor, neurosensory, or neurocerebellar)
No prior grade 3 or 4 sensory or motor neuropathy related to chemotherapy

Other:

No uncontrolled severe medical illness or infection
HIV negative
No other malignancies within the past 5 years except curatively resected basal cell skin cancer or carcinoma in situ of the cervix
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

See Radiotherapy
No prior allogeneic bone marrow or peripheral blood stem cell transplantation
At least 4 weeks since prior immunotherapy
No concurrent biological agents

Chemotherapy:

See Disease Characteristics
At least 4 weeks since prior chemotherapy

Endocrine therapy:

At least 4 weeks since prior corticosteroids at a dose greater than 10 mg/day of prednisone or equivalent

Radiotherapy:

Prior involved-field radiotherapy allowed if irradiated area is not the only source of measurable disease
Prior total body radiotherapy with high-dose therapy and autologous stem cell transplantation allowed
At least 4 weeks since prior radiotherapy
No concurrent radiotherapy to any disease site

Surgery:

At least 4 weeks since prior major surgery except for diagnosis of lymphoma
No concurrent surgical removal of any indicator lesion

Other:

At least 4 weeks since prior alternative or investigational anticancer treatment
No other concurrent systemic anticancer therapy
No other concurrent investigational drug
No concurrent phenytoin
No concurrent hepatic drug metabolism inhibitors or inducers (cytochrome P450 isoenzymes in the CYP 3A subfamily)