Metastatic Adrenal Gland Pheochromocytoma Clinical Trial
Official title:
A Phase II Study to Evaluate the Effects of 177Lu-DOTATATE in Patients With Unresectable and Progressive Rare Metastatic Endocrine Carcinomas: Medullary Thyroid Cancer, Parathyroid Carcinoma, Pituitary Carcinoma, and Malignant Pheochromocytoma/Paraganglioma
This phase II trial studies how well 177Lu-DOTATATE works in treating patients with rare endocrine cancers that have spread from where they started to nearby tissue or lymph nodes (locally advanced), spread to other places in the body (metastatic), or cannot be removed by surgery (unresectable). Radioactive drugs, such as 177Lu-DOTATATE, may carry radiation directly to cancer cells and not harm normal cells. 177Lu-DOTATATE may help to control endocrine cancers compared to standard treatment.
PRIMARY OBJECTIVE:
I. Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
determined by Ia. Computed tomography (CT) or Ib. Magnetic resonance imaging (MRI).
SECONDARY OBJECTIVES:
I. To estimate progression-free survival at 1-year. II. To correlate blood pressure control
and change/discontinuation of antihypertensive medications with tumor responses in patients
with pheochromocytomas and paragangliomas (PHPGs).
III. To correlate plasma metanephrines and chromogranin A with tumor responses in patients
with PHPGs.
IV. To correlate calcitonin, carcinoembryonic antigen, and chromogranin A with tumor
responses in patients with medullary thyroid carcinoma (MTCs).
V. To correlate pituitary hormones (depending on particular tumor, e.g. prolactin for
prolactinomas, insulin-like growth factor (IGF-1) for acromegaly, adrenocorticotropic hormone
(ACTH) and 24-hour urine free cortisol for Cushing disease, and chromogranin A with tumor
responses in patients with functional pituitary carcinomas).
VI. To correlate calcium, intact parathyroid hormone (iPTH), and chromogranin A with tumor
responses in patients with parathyroid carcinoma.
VII. Toxicity assessment by the Common Terminology Criteria for Adverse Events version 5.0
(CTCAE 5.0).
VIII. To correlate tumor responses with tumor uptake score in somatostatin receptor
scintigraphy, overall prognosis and responsiveness to lutetium Lu 177 dotatate
(177Lu-DOTATATE).
IX. To determine the percentage of tumors that demonstrate uptake on diagnostic
68Gallium-DOTATATE positron emission tomography (PET)/CT that would make treatment with
177Lu-DOTATATE feasible.
EXPLORATORY OBJECTIVES:
I. To evaluate pituitary function in all patients to look for possible radiation late effects
on the pituitary gland.
II. To estimate best biochemical response for specific tumor markers in patients with
non-measurable disease.
III. To correlate biochemical response in patients with non-measurable disease with RECIST
1.1 tumor response criteria for patients with non-measurable disease.
OUTLINE:
Patients receive 177Lu-DOTATATE intravenously (IV) over 30 minutes every 8-16 weeks.
Treatment continues for up to 52 weeks in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed up at week 72 and then every 24
weeks for up to 5 years.
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