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Radioactive Drug (177Lu-DOTATATE) for the Treatment of Locally Advanced, Metastatic, or Unresectable Rare Endocrine Cancers

2019-10-02 07:21:31 | BioPortfolio

Summary

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.

Description

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.

Study Design

Conditions

Locally Advanced Adrenal Gland Pheochromocytoma

Intervention

Lutetium Lu 177 Dotatate

Location

M D Anderson Cancer Center
Houston
Texas
United States
77030

Status

Not yet recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-02T07:21:31-0400

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Medical and Biotech [MESH] Definitions

A neural crest tumor usually derived from the chromoreceptor tissue of a paraganglion, such as the carotid body, or medulla of the adrenal gland (usually called a chromaffinoma or pheochromocytoma). It is more common in women than in men. (Stedman, 25th ed; from Segen, Dictionary of Modern Medicine, 1992)

Conditions in which the production of adrenal CORTICOSTEROIDS falls below the requirement of the body. Adrenal insufficiency can be caused by defects in the ADRENAL GLANDS, the PITUITARY GLAND, or the HYPOTHALAMUS.

The inner portion of the adrenal gland. Derived from ECTODERM, adrenal medulla consists mainly of CHROMAFFIN CELLS that produces and stores a number of NEUROTRANSMITTERS, mainly adrenaline (EPINEPHRINE) and NOREPINEPHRINE. The activity of the adrenal medulla is regulated by the SYMPATHETIC NERVOUS SYSTEM.

A pair of glands located at the cranial pole of each of the two KIDNEYS. Each adrenal gland is composed of two distinct endocrine tissues with separate embryonic origins, the ADRENAL CORTEX producing STEROIDS and the ADRENAL MEDULLA producing NEUROTRANSMITTERS.

19-Iodocholest-5-en-3 beta-ol. A cholesterol derivative usually substituted with radioactive iodine in the 19 position. The compound is an adrenal cortex scanning agent used in the assessment of patients suspected of having Cushing's syndrome, hyperaldosteronism, pheochromocytoma and adrenal remnants following total adrenalectomy.

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