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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00038545
Enrollment
25
Registered
2002-06-03
Start date
2001-05-18
Completion date
2004-04-27
Last updated
2018-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkin's Lymphoma

Keywords

LYMPHOMA, NON-HODGKINS, AGGRESSIVE, RELAPSED AND REFRACTORY

Brief summary

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

Interventions

DRUGPaclitaxel
DRUGTopotecan

Sponsors

M.D. Anderson Cancer Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026