A Phase II Study of Paclitaxel and Topotecan With Filgrastim-SD/01 Support For Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma

INCLUSION:

- 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
weeks.

- 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.

EXCLUSION:

- 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
filgrastim/neupogen).