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.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00038545
First received: May 31, 2002
Last updated: January 20, 2012
Last verified: January 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038545

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

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00038545     History of Changes
Other Study ID Numbers: DM01-008
Study First Received: May 31, 2002
Last Updated: January 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
LYMPHOMA
NON-HODGKINS
AGGRESSIVE
RELAPSED AND REFRACTORY

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Aggression
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Behavioral Symptoms
Paclitaxel
Topotecan
Lenograstim
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on September 18, 2014