NCT00132015

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2006

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2005

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

March 15, 2012

Status Verified

March 1, 2012

Enrollment Period

1.6 years

First QC Date

August 16, 2005

Last Update Submit

March 14, 2012

Conditions

Chronic Myeloproliferative DisordersLeukemiaLymphomaNonneoplastic ConditionPrecancerous Condition

Keywords

Waldenström macroglobulinemiamulticentric Castleman diseaseunicentric Castleman diseaseadult grade III lymphomatoid granulomatosispolycythemia veraessential thrombocythemiahairy cell leukemiamonoclonal gammopathy of undetermined significanceadult Burkitt lymphomaadult diffuse large cell lymphomaadult diffuse mixed cell lymphomaadult diffuse small cleaved cell lymphomaadult immunoblastic large cell lymphomaadult lymphoblastic lymphomagrade 1 follicular lymphomagrade 2 follicular lymphomagrade 3 follicular lymphomamantle cell lymphomamarginal zone lymphomasmall lymphocytic lymphomaprecancerous condition

Outcome Measures

Primary Outcomes (1)

  • Objective response (complete and partial response)

Secondary Outcomes (1)

  • 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

Interventions

tanespimycinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

NCI - Center for Cancer Research

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Myeloproliferative DisordersLeukemiaLymphomaPrecancerous ConditionsWaldenstrom MacroglobulinemiaMulti-centric Castleman's DiseaseAngiolymphoid Hyperplasia with EosinophiliaPolycythemia VeraThrombocythemia, EssentialLeukemia, Hairy CellMonoclonal Gammopathy of Undetermined SignificanceBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

tanespimycin

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersEosinophiliaLeukocyte DisordersGranulomaSkin DiseasesSkin and Connective Tissue DiseasesBone Marrow NeoplasmsHematologic NeoplasmsNeoplasms by SiteBlood Coagulation DisordersThrombocytosisBlood Platelet DisordersHypergammaglobulinemiaEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, LymphoidLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Antonio T. Fojo, MD, PhD

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

August 16, 2005

First Posted

August 19, 2005

Study Start

May 1, 2006

Primary Completion

December 1, 2007

Study Completion

June 1, 2008

Last Updated

March 15, 2012

Record last verified: 2012-03

Locations

US(2)