A Study of PTS for Patients With Solid Tumors
| Status: | Withdrawn |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | May 1, 2018 |
| End Date: | August 1, 2019 |
A Phase I Open-Label, Dose-Escalation Study of Para-toluenesulfonamide Injection (PTS) Administered Intratumorally and Locally to Patients With Solid Tumors
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.
intratumoral injections over a treatment course of two 5-day cycles to patients with palpable
advanced solid malignancies who have failed standard treatment.
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.
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.
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.
We found this trial at
1
site
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
Click here to add this to my saved trials
