Personalized PRRT of Neuroendocrine Tumors

Study Purpose

In this study, peptide receptor radionuclide therapy (PRRT) with 177Lu-Octreotate (LuTate) will be personalized, i.e. administered activity of LuTate will be tailored for each patient to maximize absorbed radiation dose to tumor, while limiting that to healthy organs. The purpose of this study is to:

- Assess the objective (radiological), symptomatic and biochemical response rates following an induction course of personalized PRRT; - Assess the overall, the disease-specific, and the progression-free survival following P-PRRT; - Correlate therapeutic response and survival with tumor absorbed radiation dose; - Evaluate the acute, subacute and chronic adverse events following P-PRRT; - Correlate toxicity (i.e. occurence and severity of adverse events) with absorbed radiation doses to organs at risk; - Optimize the quantitative SPECT imaging-based dosimetry methods in a subset of 20 patients (sub-study funded by the Canadian Institutes of Health Research).

This study also has a compassionate purpose, which is to provide access to PRRT to patients.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Patient suffering from a progressive and/or symptomatic NET (any site); - Patient ineligible to, or refusing a potentially curative treatment such as surgical resection; - Patient who did not respond, is intolerant or refuses other indicated and available palliative treatments; - Demonstration of overexpression of somatostatin receptor by tumor lesions by scintigraphic imaging (Octreoscan or 68Ga positron emission tomography.

Exclusion Criteria:

- Pregnancy; - Breastfeeding;.

- Very limited survival prognosis (i.e. less than a few weeks, because of the NET disease or any other condition) or Eastern Cooperative Oncology Group (ECOG) 4 performance status; - Inability to obtain informed consent of the participant.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02754297
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	CHU de Quebec-Universite Laval
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jean-Mathieu Beauregard, MD,MSc,FRCPC
Principal Investigator Affiliation	CHU de Québec - Université Laval
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Canada
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neuroendocrine Tumors, Carcinoid Tumor, Carcinoma, Neuroendocrine

Additional Details

A prospective, single-center, non-comparative, open phase 2 study. In this study, personalized peptide receptor radionuclide therapy (P-PRRT) with 177Lu-Octreotate (LuTate) will be administered to patients with progressive and/or symptomatic inoperable neuroendocrine tumors (NET) of any origin expressing the somatostatin receptor. The primary objective to assess the objective response rate at 3 months following a four-cycle induction course of P-PRRT will be assessed for at least the first 85 participants. This study as a compassionate aim to provide access to personalized PRRT patients at CHU de Québec

- Université Laval center, and therefore this study has no pre-determined recruitment period duration or limited number of participants, and may remain open as long as necessary to fulfill this aim.

The study will continue until all participants have completed a minimum follow-up of 5 years. Interim analyses will be conducted annually.

Arms & Interventions

Arms

Experimental: Personalized PRRT (P-PRRT)

177Lu-Octreotate (LuTate) P-PRRT will be administered as follows: Renal absorbed radiation dose will be prescribed for the 4-cycle induction course (23 Gy) and for each subsequent cycle (6 Gy), with a reduction in cases of impaired renal or bone marrow function, or significant toxicity from prior cycles. The personalized activity to be administered at each cycle will be derived from renal dose per unit of injected activity that is predicted by patient characteristics or renal dose delivered during prior cycle(s). Participants responding to the induction course of P-PRRT will be eligible to receive additional consolidation and/or maintenance cycles. Participants with prior PRRT exposure outside the trial may receive less induction cycles, or only consolidation/maintenance cycle(s).

Interventions

Drug: - 177Lu-Octreotate

The induction course will consist in 4 cycles at 8-10 weeks intervals. Concomitant amino acids will be administered for renal protection. Intra-arterial LuTate administration will be allowed in suitable cases. Dosimetry will be based on quantitative SPECT/CT imaging. In patients with hormonal symptoms, somatostatine analogues can be given between P-PRRT cycles.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU de Québec - Université Laval, Quebec City, Quebec, Canada

Status

Recruiting

Address

CHU de Québec - Université Laval

Quebec City, Quebec, G1R 2J6

Site Contact

Jean-Mathieu Beauregard, MD,MSc,FRCPC

[email protected]

418-555-4444

Clinical Trial Finder