Vestibular Schwannoma Clinical Trial
Official title:
Phase II Study of Lapatinib in Children and Adults With Neurofibromatosis Type 2(NF2) and NF2-related Tumors
The purpose of this study is to determine if Lapatinib has any effect on tumors found in
patients with Neurofibromatosis Type 2 (NF2). NF2 is a condition that mainly affects the
skin and nervous system. It causes non-cancerous tumors (which are known as neuromas) to
grow on the nerves around a person's body. Some signs of NF2 include a gradual loss of
hearing and tumors growing on the skin, the brain and the spinal cord which can lead to
complications.
Lapatinib is an oral drug that is approved by Food and Drug Administration (FDA) for other
types of tumors, it is not approved by the FDA for treatment of NF2 related tumors. The
investigators know a lot about how well it is tolerated, but the investigators do not know
if it is effective in treating your condition, therefore it is considered to be an
investigational medication. This study will test whether Lapatinib may shrink tumors
commonly found in patients with NF2 or stop them from growing. This will help us to decide
if Lapatinib should be used to treat NF2 patients in future. Lapatinib is a drug that has
been used for over 10 years to treat various forms of cancer. It has not been studied for
the treatment of tumors in NF2 patients.
Status | Active, not recruiting |
Enrollment | 17 |
Est. completion date | December 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 4 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Patients must be at least 4 years of age. 2. Patients must meet diagnostic criteria for NF2 and at least one volumetrically measured NF2-related brain or spinal tumor with radiographic evidence of progression over the past 12 months, designated as the primary target OR volumetrically measurable VS with ipsilateral progressive hearing loss over the past 12 months, designated as the primary target tumor. 3. Significant hearing loss criteria for enrollment. 4. Karnofsky (PS) OR Lansky 50-100% (>16 years of age) 5. Absolute neutrophil count = 1,000/mm3 g/dL 6. Hemoglobin = 8 g/dL 7. Creatinine = 1.5 times upper limit of normal (ULN) OR corrected glomerular filtration rate = 70 ml/min 8. Bilirubin = 1.5 times ULN 9. ALT = 2.5 times ULN 10. Fully recovered from acute toxic effects of any prior chemotherapy, biological modifiers or radiotherapy. 11. Steroids are allowed for progressive symptoms but patient must be on a stable dose for at least 1 week prior to study entry. 12. Any neurologic deficits must be stable for = 1 week. 13. Patients 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. The anti-proliferative activity of this experimental drug may be harmful to the developing fetus. 14. Normal cardiac left ventricular ejection fraction (LVEF) by transthoracic echocardiogram. 15. Able to provide written informed consent (or consent by parent/legal guardian for minors) Exclusion Criteria: 1. Patients with serious concurrent infection or medical illness. 2. Neurological deficits that are rapidly progressing. 3. Patients who are pregnant or breast-feeding. 4. Anti-tumor therapy within 4 weeks prior to enrollment. 5. Radiation therapy within 2 months prior to enrollment. 6. Prior therapy with agents targeting EGFR or ErbB2. 7. Any surgery within 4 weeks prior to enrollment. 8. Significant gastrointestinal disorder(s) 9. Known cardiac disease 10. Patients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin. Patients who have been free of disease (any prior malignancy) for more than five years are eligible for this study. 11. Patients cannot have 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) |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | New York University School of Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York University School of Medicine | GlaxoSmithKline |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To estimate the objective response rates to Lapatinib in patients with NF2-related tumors including cranial nerve schwannomas, meningiomas and ependymomas. | Every three months for one year | No | |
Secondary | To assess the toxicity of Lapatinib given daily in patients with NF2. | Monthly for one year | Yes | |
Secondary | To examine the association of objective measures of response on MRI, i.e. volumetric tumor analysis and perfusion with clinical measures of response, i.e. audiogram in patients with vestibular schwannomas (VS). | Every three months for one year | No |
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