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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04567251
Recruitment Status : Not yet recruiting
First Posted : September 28, 2020
Last Update Posted : July 23, 2021
Sponsor:
Collaborators:
Allergan
Varian Medical Systems
Information provided by (Responsible Party):
Duke University

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) during treatment (weeks 9 and 14). There will be no patient follow-up after completing or discontinuing the study.

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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
Estimated Study Start Date : August 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


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.




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



Information from the National Library of Medicine

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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. Completed a course of fractionated partial brain irradiation or whole brain irradiation of at least 30 (Gray) Gy more than 6 months prior to enrollment
  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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04567251


Contacts
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Contact: Katherine Peters, MD, PhD 919-684-5301 dukebrain1@duke.edu
Contact: Sarah Woodring 919-684-5301 dukebrain1@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Contact: Katherine Peters, MD, PhD    919-684-5301    dukebrain1@dm.duke.edu   
Contact: Sarah Woodring    919-684-5301    dukebrain1@dm.duke.edu   
Sponsors and Collaborators
Duke University
Allergan
Varian Medical Systems
Investigators
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Principal Investigator: Katherine Peters, MD, PhD Duke University
Additional Information:
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04567251    
Other Study ID Numbers: Pro00102684
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: July 23, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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