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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00038545

Collaborator

(none)

Enrollment

Location

35.3

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's Lymphoma	Drug: Filgrastim SD/01 Drug: Paclitaxel Drug: Topotecan	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 18, 2001

Actual Primary Completion Date :

Apr 27, 2004

Actual Study Completion Date :

Apr 27, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).