17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Systemic Mastocytosis (NCT00132015) | Clinical Trial Compass
CompletedPhase 2
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Systemic Mastocytosis
United States37 participantsStarted 2006-05
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin (17-AAG), work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well 17-AAG works in treating patients with systemic mastocytosis.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed systemic mastocytosis
* Objective evidence of disease, as defined by the following:
* Hemoglobin \< 10 g/dL
* Recurrent mast cell mediator-release symptoms that impair the patient's quality of life
* Symptomatic hepatosplenomegaly
* Ascites
* Symptomatic bone disease
* Profound constitutional symptoms (e.g., fatigue, asthenia, flushing, hyperpyrexia, weight loss, myalgia, and arthralgia)
* Elevated serum tryptase level
* Mast cell leukemia allowed
* Mastocytosis associated with myeloproliferative disease (e.g., hypereosinophilic syndrome or chronic myelomonocytic leukemia) allowed
* Patients with eosinophilia (i.e., absolute eosinophil count ≥ 1,000/mm\^3) must be evaluated for the presence or absence of FIP1L1-PDGFRA mutation; if the mutation is absent, the patient is eligible; if the mutation is present, the patient is eligible provided disease is refractory to imatinib mesylate
* Patients with indolent disease must have a serum tryptase level ≥ 50 ng/mL OR episodes of anaphylaxis that occur with a frequency of \> 1 per month
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 3 months
Hematopoietic
* See Disease Characteristics
* Platelet count ≥ 100,000/mm\^3 (\> 25,000/mm\^3 for patients with organomegaly)
* Absolute granulocyte count ≥ 1,500/mm\^3(\> 750/mm\^3 for patients with organomegaly)
Hepatic
* AST and ALT ≤ 2 times upper…
What they're measuring
1
Objective response (complete and partial response)
Trial details
NCT IDNCT00132015
SponsorNational Institutes of Health Clinical Center (CC)