Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire, Amiens
• Treatments: Thalidomide

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