Arsenic Trioxide, Intractable Cancer, p53 Mutations, Refractory Cancer
Conditions
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.
Interventions
DRUGArsenic 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)
Sponsors
Shanghai Changzheng Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Adverse Effect | Through study completion, an average of 1 months | Incidence of Treatment-related adverse Events |
Countries
China
Outcome results
None listed