A Phase II Study of Paclitaxel and Topotecan With Filgrastim-SD/01 Support For Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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).