Leukemia drug shows promise against rare joint tumors
NCT ID NCT01207492
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested nilotinib, a drug originally used for leukemia, in 17 patients with relapsed or metastatic pigmented villonodular synovitis (PVNS) or related giant cell tumors. The goal was to see if the drug could stop tumor growth or improve symptoms. Results focused on how long patients lived without their disease getting worse.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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17 people
The number who actually took part.
- Started
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Sep 2010
- Finished
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Aug 2015
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
Inclusion Criteria: * Histologically confirmed diagnosis of recurrent PVNS ( or diffuse-type giant cell tumor or tenosynovial giant cell tumor) that is unresectable, metastatic, or for which the patient refuses surgical intervention * Progressive disease in the last 12 months, as demonstrated by imaging or clinical appearance of new tumors, in the opinion of the treating investigator * At least one site of measurable disease according to RECIST 1.1 on MRI (or CT scan for metastatic disease) * Any number or type of prior systemic therapies, with the exception of known or suspected CSF1 receptor inhibitors as outlined in exclusion criteria below * 18 years of age or older * Life expectancy greater than 6 months * ECOG Performance Status of 0, 1 or 2 * Normal organ and marrow function as defined in the protocol * QTc less than or equal to 450 ms on 12-lead ECG * Negative urine or serum pregnancy test within days of start of study drug administration for women of childbearing potential. * Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 3 months following study drug discontinuation Exclusion Criteria: * Prior treatment with known or suspected CSF1 receptor inhibitor, including nilotinib, imatinib, sunitinib, or sorafenib, or other approved or investigational tyrosine kinase inhibitors used for treatment of diffuse-type giant cell tumor * Concurrent treatment with other investigational agents * Inability to tolerate or contraindication to MRI scanning for participants with localized disease * Impaired cardiac function * Current treatment with strong CYP3A4 inhibitors that cannot either be discontinued or switched to a different medication prior to starting study drug * Current treatment with any medications that have the potential to prolong the QT interval and that cannot either be discontinued or switched to a different medication prior to starting study drug * Impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug * Acute or chronic pancreatic disease * Acute or chronic liver disease * Another primary malignant disease requiring systemic treatment or radiation * History of significant congenital or acquired bleeding disorder unrelated to cancer * Major surgery within 28 days prior to Day 1 of the study * Treatment with other investigational agents within 28 days of day 1 * History of non-compliance to medical regimens or inability to grant consent * Women who are pregnant or breastfeeding * Other comorbidities that would interfere with study participation or safety in the opinion of the investigator
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
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H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Sarcoma Oncology Center
Santa Monica, California, 90403, United States
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Stanford University Medical Center
Stanford, California, 94305, United States
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UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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