Thalidomide in Treating Patients With Relapsed or Progressive Systemic Mastocytosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2012-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AK002

NCT02808793

Indolent Systemic Mastocytosis

COMPLETED PHASE1

Study to Evaluate the Effect of Xolair(Omalizumab) on Improving the Tolerability of Specific Immunotherapy in Patients With at Least Moderate Persistent Allergic Asthma Inadequately Controlled With Inhaled Corticosteroids

NCT00691873

Asthma

COMPLETED PHASE4

Efficacy and Safety Study of Dovramilast in People With Leprosy Type 2 Reaction

NCT07172659

Erythema Nodosum Leprosum

NOT_YET_RECRUITING PHASE2

Efficacy of Rituximab For the Treatment of Calcineurin Inhibitors Dependent Nephrotic Syndrome During Childhood

NCT01268033

Childhood Idiopathic Nephrotic Syndrome

COMPLETED PHASE2/PHASE3

Safety and Effectiveness of h5G1.1-mAb for Dermatomyositis

NCT00005571

Dermatomyositis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non Neoplastic Condition Precancerous Condition

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Thalidomide

Use of thalidomide

Group Type EXPERIMENTAL

thalidomide

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

thalidomide

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No