A Phase II Study of Paclitaxel and Topotecan With Filgrastim-SD/01 Support For Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
About this trial
This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring LYMPHOMA, NON-HODGKINS, AGGRESSIVE, RELAPSED AND REFRACTORY
Eligibility Criteria
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).
Sites / Locations
- UT MD Anderson Cancer Center