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Arsenic Trioxide for Structural p53 Mutations

Sponsor
Shanghai Changzheng Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04695223
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
10
Anticipated Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

TP53 is the most frequently mutated gene in cancer, but these mutations remain therapeutically non-actionable. Previous study reported arsenic trioxide could rescue structural p53 mutations, endowing p53 mutations with thermostability and transcriptional activity. Under Vivo and Vitro experiments, arsenic trioxide could reactivate mutated p53 to inhibit tumor. This trial aimed to explore the efficacy and safety of arsenic trioxide in refractory cancer patients with structural p53 mutations.

Condition or Disease Intervention/Treatment Phase
  • Drug: Arsenic Trioxide
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Targeting Structural p53 Mutations With Arsenic Trioxide for Intractable Cancer
Anticipated Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Aug 31, 2021
Anticipated Study Completion Date :
Oct 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arsenic Trioxide

Arsenic Trioxide (0.16mg/kg,d1-5,ivgtt,28days as a duration) for injection

Drug: Arsenic Trioxide
Refractory cancer patients without standard-of-care harboring TP53 mutation received Arsenic Trioxide Injection (0.16mg/kg,d1-5,ivgtt,28days as a duration)
Other Names:
  • As2O3
  • Arsenic

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate [Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months]

      Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission

    2. Progress Free Survival [Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months]

      Time from treatment beginning until disease progression

    Secondary Outcome Measures

    1. Overall Survival [From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months]

      Time from treatment beginning until death from any cause

    2. Adverse Effect [Through study completion, an average of 1 months]

      Incidence of Treatment-related adverse Events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Malignant solid tumors diagnosed histologically;

    • Solid tumor patients have no any standard choice after multiple line of therapy;

    • Next-generation Sequence showed TP53 mutation;

    • Expected survival ≥ 1 month;

    • ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN); Liver ALT and AST <2.5 × ULN and if liver metastases, ALT and AST <5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min

    • normal cardiac function

    • obtain informed consent

    Exclusion Criteria:

    • Patient still has standard treatment therapy based on NCCN guidance;

    • Patient can not comply with research program requirements or follow-up;

    • woman who are pregnant or breastfeeding;

    • allergic to any drug in protocol or with contraindications;

    • cannot understand or obey the protocol;

    • with a history of allergies or intolerability;

    • participate in other clinical trials meanwhile;

    • any situations that hinder trial existed;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Medical Oncology, Shanghai Changzheng Hospital Shanghai China

    Sponsors and Collaborators

    • Shanghai Changzheng Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yuan-Sheng Zang, Department Director, Shanghai Changzheng Hospital
    ClinicalTrials.gov Identifier:
    NCT04695223
    Other Study ID Numbers:
    • ANTI-P53
    First Posted:
    Jan 5, 2021
    Last Update Posted:
    Jan 6, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Arsenic Trioxide

    Study Results

    No Results Posted as of Jan 6, 2021