A Study of PTS for Patients With Solid Tumors

• Status: Withdrawn
• Trial end date: 2019-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PTS International Inc.

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.