TKI 258 in Von Hippel-Lindau Syndrome (VHL) (NCT01266070) | Clinical Trial Compass
TerminatedPhase 2
TKI 258 in Von Hippel-Lindau Syndrome (VHL)
Stopped: Trial met toxicity stopping rule
United States6 participantsStarted 2012-11
Plain-language summary
The goal of this clinical research study is to learn if dovitinib can safely be given to patients who have VHL with a measurable hemangioblastoma (tumor of the central nervous system). The effects of this drug on the disease will also be studied.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients must have genetically confirmed Von Hippel-Lindau (VHL) disease or patients with a clinical diagnosis of VHL.
✓. At least one of the following measurable hemangioblastomas which is undergoing surveillance and the patient is not at immediate risk of needing intervention for this or other lesions. a.) Brain: asymptomatic hemangioblastoma, \> 0.5 cm; b.) Spine: asymptomatic hemangioblastoma, \> 0.5 cm; c.) Renal: solid mass suspicious for RCC \>/=1 cm or cystic mass \>/=1 cm; d.) Pancreas: solid mass \>/=1cm and \< 3 cm suspicious for neuroendocrine tumor; e.) Eye: asymptomatic peripapillary and/or macular hemangioblastoma, any size f. Adrenal: Pheochromocytoma greater than 1cm in size. NOTE: Biopsy is not required given the known natural history in the setting of a positive genetic test.
✓. Allowable prior therapy: a.) Patients having undergone prior therapy for VHL lesions may enroll as long as other criteria are met. Previously radiated lesions may not be considered as target lesions unless they demonstrate unequivocal evidence of growth; b.) Major surgery, chemotherapy or radiation therapy completed \> 4 weeks prior to starting the study treatment.
✓. Age \>/= 18 years. Because no dosing or adverse event data are currently available on the use of dovitinib in patients \< 18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable
✓. ECOG performance status \</= 2
✓. Patients must have normal organ and marrow function as defined below: a.) Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase \[SGOT\]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase \[SGPT\]) \</=2.5 x local laboratory upper limit of normal (ULN) are due to underlying malignancy; b.) Total serum bilirubin \</=1.5 x ULN; c.) Absolute neutrophil count (ANC) \>/= 1500/mcL; d.) Platelets \>/=100,000/mcL; e.) Hemoglobin \>/= 9.0 g/dL; f.) Serum creatinine \< 1.5 x ULN; g) WBC \>/= 3,000/mcl
✓
What they're measuring
1
Most Frequent & Most Serious Adverse Events: Safety of Dovitinib for 6 Months
Timeframe: Every 2 cycles (approximately 8 weeks) for 6 months
. Males (that have not been sterilized) and females of childbearing potential (female that has not be amenorrheic for at least 1 year or that has not surgically sterilized) must agree to use double-barrier birth control or abstinence while on the protocol treatment
✓. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
✕. Patients who have had chemotherapy or radiotherapy within 4 weeks prior to starting study treatment or those who have not recovered (\</= Grade 1 )from adverse events due to agents administered more than 4 weeks earlier.
✕. Patients may not be receiving any other investigational agents.
✕. Patients with any metastatic disease of any kind.
✕. NCI CTCAE grade 3 hemorrhage within 4 weeks of starting the study treatment.
✕. Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
✕. Ongoing cardiac dysrhythmias of NCI CTCAE grade \>/= 2.
✕. Prolonged QTc interval on baseline EKG \> 470ms.
✕. Hypertension that cannot be controlled by medications (\>140/90 mm Hg despite optimal medical therapy).