A Phase II Study of Paclitaxel and Topotecan With Filgrastim-SD/01 Support For Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma
NCT ID: NCT00038545
Last Updated: 2018-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2001-05-18
2004-04-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Filgrastim SD/01
Paclitaxel
Topotecan
Eligibility Criteria
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Inclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Anas Younes, MD
Role: PRINCIPAL_INVESTIGATOR
UT MD Anderson Cancer Center
Locations
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UT MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Other Identifiers
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DM01-008
Identifier Type: -
Identifier Source: org_study_id
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