Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis (NCT00769587) | Clinical Trial Compass
CompletedNot Applicable
Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis
FranceStarted 2007-06
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Objective reduction of the infiltration rate at 6 months