17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Systemic Mastocytosis

Tracking Information
First Submitted Date ICMJE	August 16, 2005
First Posted Date ICMJE	August 19, 2005
Last Update Posted Date	March 15, 2012
Study Start Date ICMJE	May 2006
Actual Primary Completion Date	December 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 16, 2006)	Objective response (complete and partial response)
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00132015 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 16, 2006)	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
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Systemic Mastocytosis
Official Title ICMJE	A Phase II Clinical Trial of 17-(Allylamino)-17- Demethoxygeldanamycin (17-AAG, NSC 330507 and EPL Diluent, NSC 704057) in Adults With Systemic Mastocytosis
Brief 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.
Detailed Description	OBJECTIVES: Primary; Determine the efficacy of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG), in terms of decreases in the number of mast cells in the bone marrow and in serum tryptase levels, in patients with systemic mastocytosis. Secondary; Determine the quality of life of patients treated with this drug.; Determine hematological and non-hematological toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 2-6 hours on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive at least 2 additional courses beyond CR. Patients achieving a partial response receive at least 4 additional courses beyond their maximum response. Selected patients may receive additional courses of therapy beyond the protocol guidelines at the discretion of the principal investigator. Quality of life is assessed at baseline and before each treatment course. PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within approximately 10-18 months.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Chronic Myeloproliferative Disorders; Leukemia; Lymphoma; Nonneoplastic Condition; Precancerous Condition
Intervention ICMJE	Drug: tanespimycin
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Estimated Enrollment ICMJE; (submitted: November 8, 2006)	37
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	June 2008
Actual Primary Completion Date	December 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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 investigator
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00132015
Other Study ID Numbers ICMJE	060076; 06-C-0076; NCI-6454; NCI-P6175; CDR0000438778
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	National Institutes of Health Clinical Center (CC)
Collaborators ICMJE	National Cancer Institute (NCI)
Investigators ICMJE	Principal Investigator: Antonio T. Fojo, MD, PhD National Cancer Institute (NCI)
PRS Account	National Institutes of Health Clinical Center (CC)
Verification Date	March 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP