Are you or your loved ones suffering from metastatic neuroendocrine tumor?
You may be eligible to participate in a metastatic neuroendocrine tumor clinical trial.
Are you or your loved ones suffering from metastatic neuroendocrine tumor? You may be eligible to participate in a metastatic neuroendocrine tumor clinical trial.
Where you'll go
Peter M Anderson, MD, PhD 216-445-4007
Details for the study
Treatments and/or Procedures
Inclusion Criteria: - Subjects must have unresectable, recurrent, locally advanced, or metastatic neuroendocrine tumor including A) Cohort A. Unresectable, recurrent, locally advanced, or metastatic Pheochromocytoma-paraganglioma (PC-PG) who have failed or are refractory to available therapies . N=12. B) Cohort B will include only patients with unresectable, locally advanced or metastatic tumors who have failed or are refractory to available therapyOther neuroendocrine cancer varieties as characterized by expression of neuroendocrine markers on tumor tissue including CD56, synaptophysin, , chromogranin and/or presence of a detectable serum or urine biomarker (3-methoxytyramine, normetanephrine, metanephrines, homovanillic acid (HVA), vanillylmandelic acid (VMA), and dopamine, Varieties will include neuroblastoma, Ewing sarcoma, neuroectodermal tumor, clear call sarcoma, myoepithelial tumor, primitive neuroectodermal tumor (PNET), desmoplastic small round cell tumor, round cell sarcoma, and unresectable, metastatic or locally advanced , well-differentiated neuroendocrine tumors who have relapsed or are refractory to at least 2 systemic therapies (e.g. lanreotide, sunitinib, or everolimus). Patients with small cell carcinomas will not be included in this clinical trial.N=12 - There is no limit on number of prior therapies. - Subjects must have normal organ and marrow function as defined below. Studies should be done within 3 weeks prior to enrollment - Hemoglobin ≥ 10.0 g/dl - Leukocytes ≥ 1500/mcL - Absolute neutrophil count ≥ 1,000/mcL - Platelet count ≥ 75000/mcL - Total bilirubin within 1.5 x normal institutional limits - Aspartate aminotransferase (AST) (SGOT) ≤ 5 X institutional upper limit of normal - Alanine aminotransferase (ALT) (SGPT) ≤ 5 X institutional upper limit of normal - Serum Creatinine <3.0mg/dL - ≥ 1 lesion detectable on CT, MRI, 18FDG PET-CT, or PET-MRI - Subjects must have the ability to understand and the willingness to sign a written informed consent document - Performance status: Karnofsky Performance status ≥ 60% Exclusion Criteria: - Subjects not able to take oral drugs - Subjects receiving any other investigational agents - Subjects receiving cytotoxic chemotherapy - Patients who occasionally or regularly use medications that impact dopamine receptor signaling and can cause side effects in people with neuroendocrine tumors including PC-PG such as metaclopromide, chlorpromazine, prochlorperazine, droperidol, ephedrine, pseudoephedrine, fenfluramine, methylphenidate, phentermine, amitryptiline, imipramine, tranylcypromine, moclobemide, phenelzine, paroxetine, and fluoxetine - Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, severe, uncontrolled hypertension (systolic >150/diastolic>100mmHg) or other symptoms of catecholamine excess after efforts to achieve adequate alpha blockade then beta blockade - Psychiatric illness/social situations that would limit compliance with study requirements including returning for scans, taking oral medication, home monitoring of blood pressure and heart rate, recording side effects in a self-report diary, or becoming pregnant while on study drug - Pregnant and breast-feeding subjects - Patients with prolactinomas
Interested in participating?
Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center
Cleveland, OH, USA 44195
Peter M Anderson, MD, PhD 216-445-4007