NCT00373646CompletedPhase 2
Phase II Trial of Thalidomide (Thalidomide Pharmion) in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
Medical University of Vienna2 sites in 1 country8 target enrollmentStarted: June 1, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Medical University of Vienna
- Enrollment
- 8
- Locations
- 2
- Primary Endpoint
- To evaluate the clinical potential of thalidomide to induce objective/histologic responses in patients with MALT lymphoma
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
To evaluate the clinical potential of thalidomide to induce objective/histologic responses in patients with MALT lymphoma
Time Frame: 6 months
Secondary Outcomes
- To evaluate the safety of thalidomide in this patient population and to evaluate(6 months)
- The impact of thalidomide on progression free survival(12 months)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Phase 2
A Randomized Phase II Study of Oral Thalidomide in Patients With Hormone-Refractory Prostate CancerProstatic NeoplasmNCT00001446National Cancer Institute (NCI)64
Completed
Phase 2
Thalidomide in Treating Patients With Recurrent or Persistent Endometrial CancerEndometrial AdenoacanthomaEndometrial AdenocarcinomaEndometrial Adenosquamous Cell CarcinomaEndometrial Clear Cell CarcinomaEndometrial Papillary Serous CarcinomaRecurrent Endometrial CarcinomaNCT00025467National Cancer Institute (NCI)60
Terminated
Phase 2
Safety and Efficacy Study of Thalomid in Patients With Chronic PancreatitisChronic PancreatitisNCT00469703Winthrop University Hospital10
Completed
Phase 2
Thalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin's LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Small Lymphocytic LymphomaNCT00022581National Cancer Institute (NCI)45
Completed
Phase 2
Thalidomide in Treating Patients With Myelodysplastic Syndromede Novo Myelodysplastic SyndromesPreviously Treated Myelodysplastic SyndromesRefractory Anemia With Excess BlastsRefractory Anemia With Excess Blasts in TransformationRefractory Anemia With Ringed SideroblastsSecondary Myelodysplastic SyndromesChronic Myelomonocytic LeukemiaRefractory AnemiaNCT00015990National Cancer Institute (NCI)29