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Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis

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.
ClinicalTrials.gov Identifier: NCT00769587
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

RATIONALE: Thalidomide may stop the growth of systemic mastocytosis by blocking blood flow to the disease.

PURPOSE: This phase II trial is studying how well thalidomide works in treating patients with relapsed or progressive systemic mastocytosis.


Condition or disease Intervention/treatment Phase
Non Neoplastic Condition Precancerous Condition Drug: thalidomide Phase 2

Detailed Description:

OBJECTIVES:

Primary

  • Determine the objective response rate at 6 months in patients with systemic mastocytosis treated with thalidomide.

Secondary

  • Determine the tolerability of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral thalidomide once daily for 6 months in the absence of disease progression.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Thalidomide in Mastocytosis
Study Start Date : June 2007
Primary Completion Date : May 2011
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Thalidomide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Thalidomide
Use of thalidomide
Drug: thalidomide


Outcome Measures

Primary Outcome Measures :
  1. Objective reduction of the infiltration rate at 6 months [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of systemic mastocytosis

    • Aggressive or borderline (smoldering) disease (in first line or more)
    • Relapsed or progressive disease
  • Measurable or evaluable disease
  • Presence of c-Kit D816V mutation in the skin, spine, or infiltrated organs
  • No nonsymptomatic mastocytosis

PATIENT CHARACTERISTICS:

  • Life expectancy > 3 months
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for 1 month prior to, during, and until first menstrual cycle after completion of study treatment
  • Bilirubin < 2 times normal (unrelated to disease)
  • Liver enzymes < 2 times normal (unrelated to disease)
  • Creatinine ≤ 300 mmol/L
  • No central or peripheral neuropathy leading to psychiatric concerns
  • No HIV positivity
  • No active infection or other serious underlying illness that would preclude treatment
  • No history of thromboembolism or deep vein thrombosis
  • No geographical, social, or psychological reasons preventing medical monitoring

PRIOR CONCURRENT THERAPY:

  • More than 4 weeks since prior antitumor therapy (e.g., chemotherapy, radiotherapy)
  • No other concurrent treatment specific for this disease
  • No concurrent participation in another experimental drug trial
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00769587


Locations
France
Centre Hospitalier Universitaire d'Amiens
Amiens, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Study Chair: Gandhi Damaj Centre Hospitalier Universitaire, Amiens
More Information

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT00769587     History of Changes
Other Study ID Numbers: PI06-DR-DAMAJ
CHU-AMIENS-PI06
EUDRACT-2006-005087-10
INCA-RECF0510
First Posted: October 9, 2008    Key Record Dates
Last Update Posted: April 26, 2016
Last Verified: April 2016

Keywords provided by Centre Hospitalier Universitaire, Amiens:
aggressive systemic mastocytosis
smoldering systemic mastocytosis

Additional relevant MeSH terms:
Disease
Mastocytosis
Precancerous Conditions
Mastocytosis, Systemic
Pathologic Processes
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Skin Diseases
Thalidomide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents