For patients with relapsed and refractory aggressive non-Hodgkin's lymphoma
- Bidimensionally measurable current/refractory aggressive NHL (Diffuse lg cell,
diffuse mixed cell, follicular lg non-cleaved, immunoblastic, Ki-1+ALCL, peripheral
T-cell lymphoma, mantle cell lymphoma & transformed lymphoma.)
- No more than 3 prior treatment regimens. No anti-lymphoma therapy within the past 3
- Not be eligible for treatment of a higher priority.
- Performance status <2 Zubrod, > 60 Karnofsky.
- Good marrow reserve: ANC>1.5 x 10(9)/L, platelets > 100 x 10(9)/L.
- Bilirubin <1.5mg/dL, SGOT, SGPT < 2 x normal values.
- Serum creatinine < 1.8 mg/dL.
- Age > 18 yrs.
- Signed informed consent.
- Life expectancy of > 12 weeks.
- No prior Taxane (paclitaxel or docetaxel), topotecan, or CPT-11.
- No prior stem cell or bone marrow transplantation.
- No prior second malignancies except for basal cell carcinoma of the skin.
- Active or prior history of CNS lymphoma.
- Serious intercurrent medical illnesses requiring hospitalization.
- History of primary/secondary immunodeficiency (other than related to the malignant
lymphoma because treatment is dependent on a functional immune system) or patients
taking immunosuppressive drugs (systemic corticosteroids).
- Prior exposure to Filgrastim-SD/01.
- Women who are pregnant or lactating.
- Participation in another clinical trial.
- Positive HIV antibody.
- History of prior sensitivity to E. coli derived products (such as