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

October 29, 2018 updated by: M.D. Anderson Cancer Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 18, 2001

Primary Completion (Actual)

April 27, 2004

Study Completion (Actual)

April 27, 2004

Study Registration Dates

First Submitted

May 31, 2002

First Submitted That Met QC Criteria

May 31, 2002

First Posted (Estimate)

June 3, 2002

Study Record Updates

Last Update Posted (Actual)

October 30, 2018

Last Update Submitted That Met QC Criteria

October 29, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM01-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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