A Study of PTS for Patients With Solid Tumors
- Registration Number
- NCT03448211
- Lead Sponsor
- PTS International Inc.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Para-toluenesulfonamide Injection (PTS) Para-toluenesulfonamide Injection (PTS) Investigational product
- Primary Outcome Measures
Name Time Method Maximum tolerable dose 4 weeks post-treatment Maximum tolerable dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States