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

M.D. Anderson Cancer Center

Status and phase

Completed

Phase 2

Conditions

Non-Hodgkin's Lymphoma

Treatments

Drug: Filgrastim SD/01

Drug: Topotecan

Drug: Paclitaxel

Study type

Interventional

Funder types

Other

Identifiers

DM01-008

Details and patient eligibility

About

For patients with relapsed and refractory aggressive non-Hodgkin's lymphoma

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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).