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Old drug, new hope? thalidomide tested for rare mast cell cancer

NCT ID NCT00769587

Disease control Sponsor: Centre Hospitalier Universitaire, Amiens Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested the drug thalidomide in people with systemic mastocytosis, a rare disease where too many mast cells build up in the body. The goal was to see if thalidomide could reduce the amount of disease in the bone marrow or other organs after 6 months. The trial included adults with aggressive or worsening disease who had already tried other treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
thalidomide
What this could lead to
If it works, this could point toward a treatment option for systemic mastocytosis that slows or reduces disease activity.
What could go wrong
This is a small, early-phase trial (Phase II) with no control group. Thalidomide has known side effects, and the results may not lead to a standard treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Start date

Jun 2007

Finished

Oct 2012

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

disease Mastocytosis, Systemic precancerous condition systemic mastocytosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non neoplastic condition Precancerous condition

Contacts and locations

Locations

  • Centre Hospitalier Universitaire d'Amiens

    Amiens, 80054, France

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