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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

This study has been completed.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: May 31, 2002
Last updated: January 20, 2012
Last verified: January 2012
For patients with relapsed and refractory aggressive non-Hodgkin's lymphoma

Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: Filgrastim SD/01
Drug: Paclitaxel
Drug: Topotecan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Enrollment: 25
Study Start Date: May 2001
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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.


  • 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).
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Please refer to this study by its identifier: NCT00038545

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Anas Younes, MD UT MD Anderson Cancer Center
  More Information

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00038545     History of Changes
Other Study ID Numbers: DM01-008
Study First Received: May 31, 2002
Last Updated: January 20, 2012

Keywords provided by M.D. Anderson Cancer Center:

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Behavioral Symptoms
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors processed this record on April 26, 2017