Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis

Precancerous Condition Clinical Trial

Official title:

Phase II Study of Thalidomide in Mastocytosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00769587
• Other study ID #: PI06-DR-DAMAJ
• Secondary ID: CHU-AMIENS-PI06E
• Status: Completed
• Phase: Phase 2
• First received: October 8, 2008
• Last updated: April 25, 2016
• Start date: June 2007
• Est. completion date: October 2012

Study information

• Verified date: April 2016
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : Afssaps
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Mastocytosis
• Non Neoplastic Condition
• Precancerous Condition
• Precancerous Conditions

Intervention

Drug:
• thalidomide

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire d'Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective reduction of the infiltration rate at 6 months		6 months	No