Solid Tumor Clinical Trial
Official title:
A Phase I Open-Label, Dose-Escalation Study of Para-toluenesulfonamide Injection (PTS) Administered Intratumorally and Locally to Patients With Solid Tumors
Verified date | April 2018 |
Source | PTS International Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 1, 2019 |
Est. primary completion date | May 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
PTS International Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerable dose | Maximum tolerable dose | 4 weeks post-treatment |
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