Thalidomide in Mucosa Associated Lymphoid Tissue (MALT) Lymphoma Patients

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00373646
First received: September 7, 2006
Last updated: June 17, 2009
Last verified: June 2009
  Purpose

The purpose of this study is to evaluate Thalidomide for treatment of disseminated MALT Lymphoma or at relapse following helicobacter pylori (HP) - eradication or chemotherapy or radiation.


Condition Intervention Phase
MALT Lymphoma
Drug: Thalidomide, Pharmion
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: Phase II Trial of Thalidomide (Thalidomide Pharmion) in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • To evaluate the clinical potential of thalidomide to induce objective/histologic responses in patients with MALT lymphoma [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety of thalidomide in this patient population and to evaluate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • The impact of thalidomide on progression free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: June 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Thalidomide, Pharmion
    200 mg p.o. daily
Detailed Description:

The objectives of this study are to evaluate the effectivity and the safety of thalidomide in patients with disseminated MALT lymphoma or at relapse following HP-eradication, or chemotherapy or radiation. It is a phase II prospective single arm study with a target sample size of 16 patients. Thalidomide is given orally at an initial dose of 100 mg for a maximum duration of 6 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologically confirmed MALT lymphoma with measurable disease (Stage I-IV)
  • With first or greater relapse after HP-eradication, radiation or chemotherapy
  • Age > 18
  • Must be able to tolerate therapy and have adequate cardiac, renal and hepatic function
  • ECOG status _< 2
  • Must be capable of understanding the purpose of the study and have given written informed consent
  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: NCT00373646

Locations
Austria
Department of Internal Medicine I
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Markus Raderer, Prof Department of Internal Medicine I
  More Information

No publications provided

Responsible Party: Medical University of Vienna, Dept of Internal Medicine I
ClinicalTrials.gov Identifier: NCT00373646     History of Changes
Other Study ID Numbers: Thalidomide-MALT, Eudract number 2005-000008-14
Study First Received: September 7, 2006
Last Updated: June 17, 2009
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Medical University of Vienna:
MALT Lymphoma
thalidomide
disseminated MALT Lymphoma or at relapse following HP-eradication
or chemotherapy or radiation

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 20, 2014