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 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00038545
• Other study ID #: DM01-008
• Status: Completed
• Phase: Phase 2
• Start date: May 18, 2001
• Est. completion date: April 27, 2004

Study information

• Verified date: October 2018
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 27, 2004
• Est. primary completion date: April 27, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Aggression
• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• Filgrastim SD/01

• Paclitaxel

• Topotecan

Locations

Country	Name	City	State
United States	UT MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States,