Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy (SPiRiT)

• ClinicalTrials.gov Identifier: NCT04567251
• Recruitment Status: Suspended
• First Posted: September 28, 2020
• Last Update Posted: January 20, 2023
• Sponsor: Duke University
• Collaborators: Allergan; Varian Medical Systems
• Information provided by (Responsible Party): Duke University

Study Description

Brief Summary:

The primary objectives of this randomized, placebo-controlled, double-blind study are to 1) assess whether or not Namzaric® improves cognitive function in cancer survivors who received prior brain irradiation as part of their standard of care therapy and 2) assess the feasibility of using a digital symptom tracking application focused on Health Related Quality of Life (HRQoL) and cognition in cancer survivors who received brain irradiation. Exploratory objectives include assessing longitudinally the effect of Namzaric® on Patient Reported Outcomes (PROs) as reported in the clinic, including measures of health-related quality of life, cognition, and financial toxicity and evaluating the safety and tolerability of administering Namzaric® to cancer survivors who have received prior irradiation.

Condition or disease	Intervention/treatment	Phase
Brain Metastases, Adult; Primary Brain Tumor; Lung Cancer	Drug: Namzaric®; Drug: Placebo	Phase 3

Detailed Description:

Patients who may participate in the study are cancer survivors who received cranial irradiation for conditions including, but not limited to: primary brain tumors, brain metastases, patients with lung cancer receiving prophylactic brain irradiation, and long-term survivors of pediatric cancers. Up to 102 patients will be randomized 1:1 so half the patients receive Namzaric® and half receive placebo. Patients on both arms will be taking Namzaric® or placebo for 17 weeks, including dose-escalation and tapering. Patients will use a symptom monitoring app, Noona® Healthcare Mobile PRO Application, to identify real-time select HRQoL and cognitive symptoms during Namzaric® vs placebo therapy. Patients will be instructed to log symptoms as often as relevant using their own personal devices, as well as be prompted to fill out the Patient-Reported Outcomes Measurement Information System Global Health Screen (PROMIS Global Health-10 and Edmonton Symptom Assessment Scale) during treatment (weeks 9 and 14). There will be no patient follow-up after completing or discontinuing the study.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy: Focus on Health-Related Quality of Life and Cognition
• Actual Study Start Date: December 28, 2021
• Estimated Primary Completion Date: April 2024
• Estimated Study Completion Date: April 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Namzaric® arm; Arm 1 will take daily Namzaric® for 17 weeks, including 3 weeks of dose-escalation, 12 weeks at a stable dose, and a 2 week taper.	Drug: Namzaric®; Namzaric® will be given for 17 weeks using the following dosing schedule: 7 mg memantine hydrochloride and 10 mg donepezil hydrochloride for 1 week, 14 mg memantine hydrochloride and 10 mg donepezil hydrochloride for 1 week, 21 mg memantine hydrochloride and 10 mg donepezil hydrochloride for 1 week, 28 mg memantine hydrochloride and 10 mg donepezil hydrochloride for 12 weeks, 14 mg memantine hydrochloride and 10 mg donepezil hydrochloride for 1 week, 7 mg memantine hydrochloride and 10 mg donepezil hydrochloride for 1 week.
Placebo Comparator: Placebo arm; Arm 2 will take daily placebo for 17 weeks, including 3 weeks of dose-escalation, 12 weeks at a stable dose, and a 2 week taper.	Drug: Placebo; Placebo drug, which will look identical to commercial Namzaric®, will be given for 17 weeks including a 3 week dose-escalation, 12 week maintenance period, and 2 week taper.

Outcome Measures

Primary Outcome Measures :

1. Effect of Namzaric® on cognition among cancer survivors who received brain irradiation [ Time Frame: Baseline, 15 weeks ]
   Mean change between baseline and 15 weeks in the Brief Cognitive Assessment (BAC) composite cognitive score within each treatment group
2. Feasibility of using a digital symptom tracking application on HRQoL and cognition in cancer survivors who received brain irradiation [ Time Frame: Baseline, 15 weeks ]
   A percentage of patients returning for their 15 week clinic appointment who initiate a PROMIS questionnaire via the mobile application at weeks 9 and 14

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Cancer survivors who received cranial irradiation including, but not limited to, primary brain tumor, brain metastases, lung cancer receiving prophylactic brain irradiation, long-term survivors of pediatric cancers
2. Initial radiation must have been completed more than 6 months prior to enrollment. Acceptable radiation therapies include fractionated partial brain irradiation, whole brain irradiation, or stereotactic radiosurgery (for any modality at least a total cumulative dose of 20 Gy) of at least 20 Gy
3. Age ≥ 18 years at the time of entry into the study
4. Karnofsky performance score (KPS) ≥ 70 or Eastern Cooperative Oncology Group (ECOG) grade ≤ 2
5. No imaging evidence of disease progression within 4 months of enrollment
6. Life expectancy > 6 months
7. Access to a smartphone, tablet, or computer with capability to utilize the mobile symptom-tracking application
8. Signed informed consent approved by the Institutional Review Board
9. Subject must be fluent in English

Exclusion Criteria:

1. Active psychiatric illness
2. Clinically significant renal disease or insufficiency at the time of screening
3. History of severe liver disease or laboratory values for liver function tests > 2.5 times the upper limit of normal at screening
4. Use of cognition-enhancing medications at the time of screening. If patients have used cognition-enhancing medications in the past, a wash-out period can be considered for screening of 8 weeks at the discretion of the PI.
5. Allergy to Namzaric or any of the components of Namzaric.
6. Pregnancy

Contacts and Locations

Locations

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Duke University

Allergan

Varian Medical Systems

Investigators

• Principal Investigator: Katherine Peters, MD, PhD; Duke University

More Information

Additional Information:

Duke Health Clinical Trials 

The Preston Robert Tisch Brain Tumor Center 

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT04567251
• Other Study ID Numbers: Pro00102684
• First Posted: September 28, 2020
• Last Update Posted: January 20, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Duke University:

Lung Cancer; Brain tumor; Solid tumor; Pediatric Cancer; Cancer Survivor; Pro00102684; Katherine Peters; Brain metastases; Radiation; Namzaric®; Cognition; Survivorship

Additional relevant MeSH terms:

Neoplasm Metastasis; Brain Neoplasms; Neoplasms by Site; Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Central Nervous System Diseases; Neoplastic Processes; Pathologic Processes; Brain Diseases; Nervous System Diseases