Arsenic Trioxide for Structural p53 Mutations

Naval Military Medical University (Second Military Medical University)

Status and phase: Unknown; Phase 2

Conditions: p53 Mutations; Intractable Cancer; Arsenic Trioxide; Refractory Cancer

Treatments: Drug: Arsenic Trioxide

Study type: Interventional

Funder types: Other

Identifiers

NCT04695223

ANTI-P53

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Arsenic Trioxide

Experimental group

Description:

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

Treatment:

Drug: Arsenic Trioxide