Status:
COMPLETED
Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis
Lead Sponsor:
Centre Hospitalier Universitaire, Amiens
Conditions:
Non Neoplastic Condition
Precancerous Condition
Eligibility:
All Genders
18-75 years
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 wit...
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 thes...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
End Date :
October 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00769587
Start Date
June 1 2007
End Date
October 1 2012
Last Update
September 22 2025
Active Locations (1)
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1
Centre Hospitalier Universitaire d'Amiens
Amiens, France, 80054