Clinical trial · Interventional
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Systemic Mastocytosis
A Phase II Clinical Trial of 17-(Allylamino)-17- Demethoxygeldanamycin (17-AAG, NSC 330507 and EPL Diluent, NSC 704057) in Adults With Systemic Mastocytosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloproliferative Disorders | Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Nonneoplastic Condition | — | UNRESOLVED | — |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tanespimycin | Drug | Tanespimycin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective response (complete and partial response)
Secondary outcomes (1)
- measure
- Quality of life as assessed by the European Organization for Research of the Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) at baseline and prior to each treatment course
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 limit of normal (ULN) (\< 4 times ULN for patients with hepatomegaly)
* Bilirubin normal
* Alkaline phosphatase ≤ 3 times ULN
Renal
* Creatinine ≤ 1.4 mg/dL OR
* Creatinine clearance ≥ 60 mL/min
Cardiovascular
* No New York Heart Association class III-IV congestive heart failure
* No history of myocardial infarction within the past year
* No history of uncontrolled dysrhythmia
* No uncontrolled angina
* No ischemic heart disease within the past 12 months
* No congenital long QT syndrome
* No left bundle branch block
* No serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
* QTc interval \< 450 msec for males or 470 msec for females
* LVEF \> 40% by MUGA
* MUGA or echocardiogram normal
* No prior history of cardiac toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride, bleomycin, or carmustine)
* No cardiac symptoms ≥ grade 2
* No other significant cardiac disease
Pulmonary
* No symptomatic pulmonary disease requiring medication including any of the following:
* Dyspnea on or off exertion
* Paroxysmal nocturnal dyspnea
* Requirement for oxygen
* Significant pulmonary disease (e.g., chronic obstructive/restrictive pulmonary disease)
* No home oxygen meeting the Medicare requirement
* No compromised pulmonary status (i.e., DLCO ≤ 80%)
* No prior history of pulmonary toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride, bleomycin, or carmustine)
* No pulmonary symptoms ≥ grade 2
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
* HIV negative
* No active uncontrolled infection
* No serious medical illness
* No other non-malignant systemic disease
* No history of serious allergic reaction to eggs
* No other malignancy within the past 2 years except dermatological cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* At least 4 weeks since prior chemotherapy
Endocrine therapy
* Steroids allowed provided tapering to the lowest level possible to treat thrombocytopenia, diarrhea, or malabsorption symptoms of systemic mastocytosis
Radiotherapy
* At least 4 weeks since prior radiotherapy
* No prior radiation that included the heart in the field (e.g., mantle) or chest
Surgery
* Not specified
Other
* At least 4 weeks since prior tyrosine kinase inhibitors
* No concurrent complimentary or alternative medications\* including, but not limited to, the following:
* Hypericum perforatum (St. John's wort)
* Milk thistle
* Kava kava
* Mistletoe extract
* No concurrent agents that cause QTc prolongation
* No concurrent antiarrhythmic therapy
* No other concurrent investigational therapy NOTE: \*Unless approved by the investigatorReferences
Publications (0)
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