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Phase II Study of Thalidomide in Mastocytosis


Phase 2
18 Years
75 Years
Not Enrolling
Both
Nonneoplastic Condition, Precancerous Condition

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Trial Information

Phase II Study of Thalidomide in 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

Objective reduction of the infiltration rate at 6 months

Safety Issue:

No

Principal Investigator

Gandhi Damaj

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Hospitalier Universitaire d'Amiens

Authority:

United States: Federal Government

Study ID:

CDR0000599564

NCT ID:

NCT00769587

Start Date:

June 2007

Completion Date:

Related Keywords:

  • Nonneoplastic Condition
  • Precancerous Condition
  • aggressive systemic mastocytosis
  • smoldering systemic mastocytosis
  • Mastocytosis
  • Urticaria Pigmentosa
  • Mastocytoma
  • Precancerous Conditions
  • Mastocytosis, Systemic

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