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Effect of NAC on Preventing Chemo-Related Cognitive Impairments in Ovarian Ca Pts Treated W/ PBT

Primary Purpose

Ovarian Cancer, Cognitive Impairment

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
N-Acetyl-Cysteine
Placebo
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Chemotherapy-Related Cognitive Impairments

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Post-menopausal females (as defined by lack of menstruation for 12 months or status post oophorectomy)

  • Histologic or pathologic diagnosis of stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer
  • Eastern Cooperative Oncology Group (ECOG) ≤2
  • Life expectancy > 1 year
  • Status post cytoreductive surgery for ovarian cancer or with planned cytoreductive surgery if treated with neoadjuvant chemotherapy
  • Prescribed a minimum of six cycles of platinum-based chemotherapy

  • Adequate organ function as defined below:

    1. Hemoglobin > 9 g/dL
    2. Leukocytes >1,500/mcl
    3. Absolute Neutrophil Count > 1,000/mcL
    4. Platelets > 125,00/mcL
    5. total bilirubin Within normal institutional limits
    6. Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 x institutional upper limit of normal
    7. Serum creatinine < 1.5 mg/dL.

Exclusion Criteria:

  • Prior history of any cancer (other than non-melanoma skin cancer)
  • Chemotherapy, radiation therapy, or erythropoietin treatment within the last 6 months
  • Prior severe head injury
  • Has a history of dementia or other neurodegenerative disorders
  • Has an uncontrolled, treatment-resistant depression or other severe psychiatric illnesses
  • Presence of known brain metastases
  • Has an active infection requiring treatment
  • Known immunosuppressive disease
  • Has active systemic autoimmune diseases such as lupus
  • Receipt of systemic immunosuppressive therapy
  • Known human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C
  • Pregnant of breastfeeding.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Phase 1 Dose Escalation

    Phase 2 Dose Expansion

    Arm Description

    Patients will receive NAC beginning at Cohort 1. If, at a given dose, none of the 3 patients shows a dose-limiting toxicity during the first cycle of PBT, then the dose is escalated 1 step for subsequent subjects. If, at a given dose, only 1 of 3 shows a dose-limiting toxicity, then up to 3 additional participants will be enrolled at that dose.If, at a given dose, the first 2, or any 2 of 3 subjects show a dose-limiting toxicity, then the dose will be de-escalated 1 step for future participants. At a dose where enrollment is expanded to between 4 and 6, if only 1 of 6 subjects shows a dose-limiting toxicity, then the dose will be escalated 1 step for future participants. However, if 2 or more of 4, 5, or 6participants show a dose-limiting toxicity, then the dose will be reduced one step for future participants. The maximum tolerated dose is defined as the highest dose not requiring deescalation. This is the dose to be used for the NAC arm of Phase II study.

    Patients will be randomized to receive NAC at the maximum tolerated dose or placebo.

    Outcomes

    Primary Outcome Measures

    Maximum Tolerated Dose of N-Acetyl-Cysteine in Ovarian Cancer Patients Receiving Platinum-Based Therapy
    Determination of the maximum tolerated dose (MTD) will be utilized to evaluate the safety and tolerability of adding N-Acetyl-Cysteine (NAC) in ovarian cancer patients who are also receiving platinum-based therapy (PBT), using a Phase I, dose-escalating design.
    Recommended Phase 2 Dose for NAC administered with PBT
    Determination of the recommended Phase 2 dose (RP2D) will be utilized to evaluate the safety and tolerability of adding NAC to PBT.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 17, 2020
    Last Updated
    March 10, 2023
    Sponsor
    University of California, Irvine
    Collaborators
    Jarrow Formulas Inc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04520139
    Brief Title
    Effect of NAC on Preventing Chemo-Related Cognitive Impairments in Ovarian Ca Pts Treated W/ PBT
    Official Title
    Phase I Dose-Escalating and Phase II Dose-Expansion Study of N-Acetyl-Cysteine (NAC) Administration to Ovarian Cancer Patients Receiving Platinum-Based Therapy (PBT) for the Mitigation of Chemotherapy-Related Cognitive Impairment (CRCI)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    October 2024 (Anticipated)
    Study Completion Date
    April 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, Irvine
    Collaborators
    Jarrow Formulas Inc

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This is a phase I, dose-escalation and phase II dose-expansion clinical trial determining the maximum tolerated dose (MTD) and safety and tolerability of adding N-Acetyl-Cysteine (NAC) to ovarian cancer patients who are receiving a platinum-based therapy (PBT). This study will investigate whether NAC will mitigate chemotherapy-related cognitive impairment (CRCI).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ovarian Cancer, Cognitive Impairment
    Keywords
    Chemotherapy-Related Cognitive Impairments

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Model Description
    Phase 1 will be a dose-escalating design. Phase 2 will be a randomized, double-blinded, placebo-controlled study design
    Masking
    ParticipantInvestigator
    Masking Description
    Phase 1 will be open label. Phase 2 will be be double-blinded.
    Allocation
    Randomized
    Enrollment
    102 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Phase 1 Dose Escalation
    Arm Type
    Experimental
    Arm Description
    Patients will receive NAC beginning at Cohort 1. If, at a given dose, none of the 3 patients shows a dose-limiting toxicity during the first cycle of PBT, then the dose is escalated 1 step for subsequent subjects. If, at a given dose, only 1 of 3 shows a dose-limiting toxicity, then up to 3 additional participants will be enrolled at that dose.If, at a given dose, the first 2, or any 2 of 3 subjects show a dose-limiting toxicity, then the dose will be de-escalated 1 step for future participants. At a dose where enrollment is expanded to between 4 and 6, if only 1 of 6 subjects shows a dose-limiting toxicity, then the dose will be escalated 1 step for future participants. However, if 2 or more of 4, 5, or 6participants show a dose-limiting toxicity, then the dose will be reduced one step for future participants. The maximum tolerated dose is defined as the highest dose not requiring deescalation. This is the dose to be used for the NAC arm of Phase II study.
    Arm Title
    Phase 2 Dose Expansion
    Arm Type
    Experimental
    Arm Description
    Patients will be randomized to receive NAC at the maximum tolerated dose or placebo.
    Intervention Type
    Drug
    Intervention Name(s)
    N-Acetyl-Cysteine
    Other Intervention Name(s)
    NAC Sustain, NAC
    Intervention Description
    Given PO
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Given PO
    Primary Outcome Measure Information:
    Title
    Maximum Tolerated Dose of N-Acetyl-Cysteine in Ovarian Cancer Patients Receiving Platinum-Based Therapy
    Description
    Determination of the maximum tolerated dose (MTD) will be utilized to evaluate the safety and tolerability of adding N-Acetyl-Cysteine (NAC) in ovarian cancer patients who are also receiving platinum-based therapy (PBT), using a Phase I, dose-escalating design.
    Time Frame
    From the start date of treatment until 6 months after removal of treatment due to toxicity, termination of study or withdrawal of treatment, whichever came first.
    Title
    Recommended Phase 2 Dose for NAC administered with PBT
    Description
    Determination of the recommended Phase 2 dose (RP2D) will be utilized to evaluate the safety and tolerability of adding NAC to PBT.
    Time Frame
    From the start date of treatment until 6 months after removal of treatment due to toxicity, termination of study or withdrawal of treatment, whichever came first.

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    This study targets post-menopausal women with a histologically confirmed diagnosis of stage III-IV eipithelial ovarian cancer, fallopian tube, or primary peritoneal cancer
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Post-menopausal females (as defined by lack of menstruation for 12 months or status post oophorectomy) Histologic or pathologic diagnosis of stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer Eastern Cooperative Oncology Group (ECOG) ≤2 Life expectancy > 1 year Status post cytoreductive surgery for ovarian cancer or with planned cytoreductive surgery if treated with neoadjuvant chemotherapy Prescribed a minimum of six cycles of platinum-based chemotherapy Adequate organ function as defined below: Hemoglobin > 9 g/dL Leukocytes >1,500/mcl Absolute Neutrophil Count > 1,000/mcL Platelets > 125,00/mcL total bilirubin Within normal institutional limits Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 x institutional upper limit of normal Serum creatinine < 1.5 mg/dL. Exclusion Criteria: Prior history of any cancer (other than non-melanoma skin cancer) Chemotherapy, radiation therapy, or erythropoietin treatment within the last 6 months Prior severe head injury Has a history of dementia or other neurodegenerative disorders Has an uncontrolled, treatment-resistant depression or other severe psychiatric illnesses Presence of known brain metastases Has an active infection requiring treatment Known immunosuppressive disease Has active systemic autoimmune diseases such as lupus Receipt of systemic immunosuppressive therapy Known human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C Pregnant of breastfeeding.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chao Family Comprehensive Cancer Center University of California, Irvine
    Phone
    1-877-827-7883
    Email
    ucstudy@uci.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    University of California Irvine Medical
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daniela Bota, MD, PhD
    Organizational Affiliation
    Chao Family Comprehensive Cancer Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of NAC on Preventing Chemo-Related Cognitive Impairments in Ovarian Ca Pts Treated W/ PBT

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