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

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

For patients with 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).