Solid Tumor
Conditions
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.
Interventions
DRUGPara-toluenesulfonamide Injection (PTS)
Intratumoral injection
Sponsors
PTS International Inc.
Study design
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerable dose | 4 weeks post-treatment | Maximum tolerable dose |
Countries
United States
Outcome results
None listed