Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis
Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis
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.
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.
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