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

NCT04106843 | Withdrawn Phase 2 FDA Drug

• 2 other identifiers: 2018-0947NCI-2019-05859
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Locally Advanced Adrenal Gland Pheochromocytoma; Locally Advanced Paraganglioma; Metastatic Adrenal Gland Pheochromocytoma; Metastatic Paraganglioma; Metastatic Parathyroid Gland Carcinoma; Pituitary Gland Carcinoma; Somatostatin Receptor Positive; Stage III Thyroid Gland Medullary Carcinoma AJCC v8; Stage IV Thyroid Gland Medullary Carcinoma AJCC v8; Stage IVA Thyroid Gland Medullary Carcinoma AJCC v8; Stage IVB Thyroid Gland Medullary Carcinoma AJCC v8; Stage IVC Thyroid Gland Medullary Carcinoma AJCC v8; Unresectable Adrenal Gland Pheochromocytoma; Unresectable Paraganglioma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 determined by computed tomography (CT) or magnetic resonance imaging (MRI). Will be calculated as the proportion of patients with complete responses (CR), partial responses (PR), or stable disease (SD) at the CT/MRI assessment time point.

  Up to 52 weeks

Study Arms (1)

Treatment (177Lu-DOTATATE)

EXPERIMENTAL

Patients receive 177Lu-DOTATATE IV over 30 minutes every 8-16 weeks. Treatment continues for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

Drug: Lutetium Lu 177 Dotatate

Interventions

Lutetium Lu 177 Dotatate DRUG

Given IV

Also known as: 177 Lu-DOTA-TATE, 177 Lu-DOTA-Tyr3-Octreotate, 177Lu-DOTA0-Tyr3-Octreotate, Lutathera, Lutetium Lu 177 DOTA(0)-Tyr(3)-Octreotate, Lutetium Lu 177-DOTA-Tyr3-Octreotate, lutetium Lu 177-DOTATATE, Lutetium Oxodotreotide Lu-177

Treatment (177Lu-DOTATATE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological confirmation of PHPG, MTC, parathyroid or pituitary tumor
• Locally advanced or distantly metastatic disease not amenable to surgery
• Patients should have somatostatin receptor (SSTR)+ tumor as determined by 68Ga-DOTATATE PET/CT imaging. A measurable SSTR+ tumor is defined as having greater than or equal to 10 mm in diameter with uptake higher than or equal to liver and is qualitatively higher and distinguishable from background activity
• In patients with multiple lesions (more than one) as determined by staging CT or MRI, the number of SSTR+ lesions should be more than or equal to the number of SSTR- lesions
• Patients enrolled in cohorts 1-4 should have measurable disease defined by RECIST 1.1
• Patients enrolled in cohort 5 should have non-measurable disease as defined by RECIST 1.1
• Progressive disease per RECIST 1.1 as determined by the investigator within the 12 months preceding study enrollment
• Radiographic assessment of all known disease sites, e.g., by computerized tomography (CT) scan, magnetic resonance imaging (MRI), bone scan as appropriate within 28 days before the first dose of (177)Lu-DOTATATE
• Disease specific hormonal studies to assess abnormal hormonal secretion within 28 days before the first dose of (177)Lu-DOTATATE. These studies may include the following: plasma metanephrines and catecholamines for PHPG, calcitonin and CEA for MTC, prolactin for malignant prolactinomas, IGF-1 for growth hormone secreting malignant somatotropinomas, ACTH for malignant corticotropinomas, intact parathyroid hormone for parathyroid carcinomas
• Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
• Life expectancy of at least 6 months
• Absolute neutrophil count (ANC) \>= 1500/mm\^3 without colony stimulating factor support (within 4 days prior to the first dose of \[177\]Lu-DOTATATE)
• Platelets \>= 100,000/mm\^3 (within 4 days prior to the first dose of \[177\]Lu-DOTATATE)
• Hemoglobin \>= 9 g/dL (within 4 days prior to the first dose of \[177\]Lu-DOTATATE)
• Bilirubin =\< 1.5 x the upper limit of normal (ULN) (within 4 days prior to the first dose of \[177\]Lu-DOTATATE). For subjects with known Gilbert's disease, bilirubin =\< 3.0 mg/dL

You may not qualify if:

• Received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., somatostatin analogues, cytokines or antibodies) within 12 weeks, or nitrosoureas/mitomycin C within 6 weeks before the first dose of study treatment. For patients with acromegaly, Cushing disease, and thyroid-stimulating hormone (TSH) secreting pituitary carcinomas treatment with somatostatin analogues is allowed
• Prior treatment with (177)Lu-DOTATATE or other radionuclide agents (e.g. (131)I meta-iodobenzylguanidine, (131)I Ultratrace Iobenguane)
• Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible
• Prior treatment of any small molecule kinase inhibitor (including investigational kinase inhibitor) within 14 days before the first dose of study treatment
• Receipt of any other type of investigational agent within 28 days before the first dose of study treatment
• The subject has not recovered to baseline or CTCAE =\< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs)
• Prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test \>= 1.3 x the laboratory ULN within 7 days before the first dose of study treatment
• Uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
• Cardiovascular disorders including
• Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening
• Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) \> 150 mm Hg systolic, or \> 90 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment
• Any of the following within 6 months before the first dose of study treatment:
• Unstable angina pectoris
• Clinically-significant cardiac arrhythmias
• Stroke (including transient ischemic attack (TIA), or other ischemic event)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Pheochromocytoma; Paraganglioma; Parathyroid Neoplasms; Pituitary Neoplasms; Carcinoma, Medullary

Interventions

lutetium Lu 177 dotatate

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Parathyroid Diseases; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Carcinoma, Neuroendocrine; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Camilo Jimenez

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 27, 2019
• Study Start: June 13, 2019
• Primary Completion: September 3, 2020
• Study Completion: September 3, 2020
• Last Updated: September 7, 2020

Record last verified: 2020-09

Locations

US (1)