Pivotal Phase II Multicenter Study of Vincristine Sulfate Liposomes Injection in Diffuse Large B-Cell Non-Hodgkin's Lymphoma That is Refractory or Relapsed After Second-Line Combination Chemotherapy Revised Title Per 03/01 SR Pivotal Phase II Multicenter Study of Vincristine Sulfate Liposomes Injection in Aggressive Non-Hodgkin's Lymphoma That is Refractory to or Relapsed After Second-Line Combination Chemotherapy

Inclusion 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)