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| Name | Class |
|---|---|
| Excel Diagnostics and Nuclear Oncology Center | OTHER |
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This is a phase II treatment protocol evaluating 177Lu-DOTATATE therapy for somatostatin receptor-expressing cancers including, but not limited to, those arising from the neural crest and involving such organs as the lungs, breast, gastrointestinal tract, skin, and endocrine (examples: pheochromocytoma, medullary carcinoma of the thyroid, non-radioiodine avid differentiated thyroid cancer, melanoma, renal cell, Merkel cell, paraganglioma, small cell lung, Carcinoid, and pancreatic islet cell malignancies).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Patients with somatostatin receptor-expressing neuroendocrine neoplasms will receive up to 200 mCi of 177Lu-DOTATATE every 6-11 weeks, preferably 6-9 weeks to a cumulative dose of 800 mCi. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 177Lu-DOTATATE | Drug | Patients will receive 200mCi dose of 177Lu Dotatate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free survival | Overall response will be determined by Progression Free Survival (PFS). PFS will be calculated as a function of time from start of therapy to time of overall disease progression. Patients will be censored at the date of last contact | one year after completion of last treatment cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity | Patients will be monitored for dose toxicity according to NCI guidelines | one year after completion of the fourth cycle of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ebrahim S Delpassand, M.D | Excel Diagnostics and Nuclear Oncology Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Excel Diagnostics and Nuclear Oncology Center | Houston | Texas | 77042 | United States |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C447941 | lutetium Lu 177 dotatate |
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| D009380 | Neoplasms, Nerve Tissue |