Arsenic Trioxide for Structural p53 Mutations

Refractory Cancer Clinical Trial

Official title:

Targeting Structural p53 Mutations With Arsenic Trioxide for Intractable Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04695223
• Other study ID #: ANTI-P53
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2021
• Est. completion date: October 31, 2021

Study information

• Verified date: January 2021
• Source: Shanghai Changzheng Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Arsenic Trioxide
• Intractable Cancer
• p53 Mutations
• Refractory Cancer

Intervention

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)

Locations

Country	Name	City	State
China	Department of Medical Oncology, Shanghai Changzheng Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission	Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months
Primary	Progress Free Survival	Time from treatment beginning until disease progression	Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months
Secondary	Overall Survival	Time from treatment beginning until death from any cause	From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months
Secondary	Adverse Effect	Incidence of Treatment-related adverse Events	Through study completion, an average of 1 months