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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00038545
Recruitment Status : Completed
First Posted : June 3, 2002
Last Update Posted : January 23, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2001
Actual Primary Completion Date : April 2004
Actual Study Completion Date : April 2004

Information from the National Library of Medicine

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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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00038545     History of Changes
Other Study ID Numbers: DM01-008
First Posted: June 3, 2002    Key Record Dates
Last Update Posted: January 23, 2012
Last Verified: January 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