Status:
COMPLETED
Concentration and Activity of Lapatinib in Vestibular Schwannomas
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
The Children's Tumor Foundation
GlaxoSmithKline
Conditions:
Vestibular Schwannoma
NF2
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Tumors can grow on the auditory nerves and can cause hearing loss. A common type of tumor that does this is a vestibular schwannoma (VS), or acoustic neuroma. These tumors are not cancerous. Most ofte...
Detailed Description
Neurofibromatosis type 2 (NF2) is a rare autosomal dominant genetic disorder with an incidence of approximately 1/40,000. The most common tumor type in NF2 is vestibular schwannoma and the majority of...
Eligibility Criteria
Inclusion
- Meet diagnostic criteria for NF2 including presence of bilateral VS or idiopathic VS without evidence of genetic syndrome.
- VS surgery determined clinically necessary by the treating physician and scheduled within 4 weeks.
- Normal cardiac left ventricular ejection fraction (LVEF) by multiple-gated acquisition (MUGA) scan or transthoracic echocardiogram.
- Karnofsky performance status 60% (i.e. the patient must be able to care for himself/herself with occasional help from others).
- Must have the following hematologic, renal and liver function: Absolute neutrophil count ≥ 1,000/mm³ (unsupported); platelet count ≥ 75,000/mm³ (unsupported); hemoglobin ≥ 8 g/dL (transfusion support allowed); Creatinine ≤ 1.5 times upper limit of normal (ULN) OR glomerular filtration rate ≥ 70 ml/min; Bilirubin ≤ 1.5 times ULN; ALT ≤ 2.5 times ULN.
- Be able to provide written informed consent.
- Any neurologic deficits must be stable for ≥ 1 week.
- Be able to swallow tablets.
- Subjects with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Women of childbearing potential must have a negative pregnancy test.
- Suspend the use of P450 inducing or P450 suppressing agents for a minimum of 10 days prior to starting lapatinib.
Exclusion
- Serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety.
- Pregnant or breast-feeding.
- Receiving concurrent therapy for their tumor (i.e. chemotherapeutics or investigational agents, radiation or immunotherapy) within 4 weeks of the first dose of the study drug.
- Concurrent or prior malignancy, other than curatively treated carcinoma-in-situ or basal cell carcinoma of the skin. Subjects who have been free of disease (any prior malignancy) for five years are eligible for this study.
- Received cytochrome P450-inducing anticonvulsants (EIADs; e.g., phenytoin, carbamazepine, phenobarbital, primidone, oxcarbazepine) or similar agents (e.g., rifampin) or P450 inhibiting agents (Ketoconazole, Itraconazole, Clarithromycin, Atazanavir, Indinavir, Nefazodone, Nelfinavir, Ritonavir, Saquinavir, Telithromycin, Voriconazole) within 10 days prior to starting lapatinib.
- Significant gastrointestinal disorder(s)(e.g., Crohn's disease, ulcerative colitis, extensive gastric resection).
- Neurologic deficits that are rapidly progressing.
- Known cardiac disease (either arrhythmia or congestive heart failure) requiring treatment.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00863122
Start Date
June 1 2009
End Date
August 1 2014
Last Update
January 12 2021
Active Locations (7)
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1
House Reserach Institute
Los Angeles, California, United States, 90057
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Washington University Medical Center
St Louis, Missouri, United States, 63110