Clinical trial NCT03448211: A Study of PTS for Patients With Solid Tumors
Official title: A Phase I Open-Label, Dose-Escalation Study of Para-toluenesulfonamide Injection (PTS) Administered Intratumorally and Locally to Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: PTS International Inc.
Sponsor class: INDUSTRY
First posted: 2018-02-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine the MTD of PTS following local and intratumoral injections over a treatment course of two 5-day cycles to patients with palpable advanced solid malignancies who have failed standard treatment.

Detailed description: The study will be an open, uncontrolled, single-center, phase I study to assess the safety and tolerability of local intra-tumoral injection 2.0ml (660mg), 4.0ml (1220mg), 6.0ml (1880mg) and 8.0ml (2440mg) PTS in female breast cancer patients.

Eligibility criteria: Inclusion Criteria:

* Subjects are diagnosed as unsuitable for surgical operations or refuse to do so.
* Subject's performance status is classified as Grade 0 to Grade 3. Estimated survival time should be longer than 6 months of time.
* Physical examinations show no serious functional disorders of the heart, liver, kidneys, or blood.
* Subjects were treated with radio or chemotherapy previously. A minimum of 2 to 3 months recovery time is required before treating with this investigational drug.
* Subject is diagnosed as intratracheal lesions with metastasized pulmonary cancer not suitable for surgery, or refuses to be operated.
* Subject should show lobular atelectasis with either complete or incomplete obstruction of the bronchi.
* Physical examinations should show no functional disorders of the heart, liver, kidneys, central nervous system, and blood.
* Subject performance status to be classified from Grade 0 to Grade 3, who can tolerate the fiberoptic bronchoscopy treatments.
* In-patient is preferred. When subject is in satisfactory conditions, the out Cpatient can also be enrolled in this trial.
* Two to three months recovery time is required for the subject has just received radio or chemotherapy.
* Emergency request, subjects with serious lobular atelectasis and almost complete obstruction of the bronchi.
* With the aid of a tracheal intubation and the help of the respirator, PTS may be intraumorally injected into the obstructed lesion via fiberoptic bronchoscopy outside of the tube, alongside of the intubation.

Exclusion Criteria:

* Pregnant women and children will not be used as test subjects.
* Subjects with serious functional disorders of the heart, liver, kidneys, or blood will be excluded.
* Subjects who do not want to participate in the trial will not be used as test subjects.
* Subject does not agree to participate.
* Subject performance status is Grade 4, and the one who does not want to tolerate the discomfort of the PTS treatments via fiberoptic bronchscopy.

Primary outcomes:
measure: Maximum tolerable dose
timeFrame: 4 weeks post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Nan-Shan Zhong
role: PRINCIPAL_INVESTIGATOR
References: