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

Tracking Information

• First Submitted Date: September 23, 2020
• First Posted Date: September 28, 2020
• Last Update Posted Date: January 20, 2023
• Actual Study Start Date: December 28, 2021
• Estimated Primary Completion Date: April 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 23, 2020)

• 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
• 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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy
• Official Title: Survivorship Study of Cancer Patients Who Received Cranial Radiation Therapy: Focus on Health-Related Quality of Life and Cognition
• 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.
• 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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment

Condition

• Brain Metastases, Adult
• Primary Brain Tumor
• Lung Cancer

Intervention

• 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.

• 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.

Study Arms

• 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.
  Intervention: Drug: Namzaric®
• 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.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Suspended
• Estimated Enrollment (submitted: September 23, 2020): 108
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2024
• Estimated Primary Completion Date: April 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04567251
• Other Study ID Numbers: Pro00102684
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Duke University
• Original Responsible Party: Same as current
• Current Study Sponsor: Duke University
• Original Study Sponsor: Same as current

Collaborators

• Allergan
• Varian Medical Systems

Investigators

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

• PRS Account: Duke University
• Verification Date: January 2023