Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis

This is an interventional treatment trial for Non Neoplastic Condition focused on measuring aggressive systemic mastocytosis, smoldering systemic mastocytosis Read More

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