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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

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Filgrastim SD/01
Paclitaxel
Topotecan
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring LYMPHOMA, NON-HODGKINS, AGGRESSIVE, RELAPSED AND REFRACTORY

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • UT MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 31, 2002
Last Updated
October 29, 2018
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00038545
Brief Title
A Phase II Study of Paclitaxel and Topotecan With Filgrastim-SD/01 Support For Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma
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 Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
May 18, 2001 (undefined)
Primary Completion Date
April 27, 2004 (Actual)
Study Completion Date
April 27, 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
Keywords
LYMPHOMA, NON-HODGKINS, AGGRESSIVE, RELAPSED AND REFRACTORY

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Filgrastim SD/01
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Type
Drug
Intervention Name(s)
Topotecan

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anas Younes, MD
Organizational Affiliation
UT MD Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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