Palpable solid tumor
Conditions
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patient with palpable solid tumor who must meet the following criteria: [1] The patient with palpable solid tumor who has local recurrence after conventional surgery , radiation and/or chemotherapy; [2] The patient with palpable solid tumor who is not suitable or refuse to receive conventional treatments; [3] The patient with palpable solid tumor who is only suitable for palliative treatments; [4]According to the results generated by the PTS phase IIa clinical study, the investigator believed the PTS treatment might shrink the tumor making a surgery possible or providing an opportunity for sergeant to reduce the extent of the surgery due to the results of tumor shrinkage induced by this treatment; 2. The patient must has biopsy confirmation; 3. The patient must have adequate tumor tissue for pathologic biopsy examination (frozen specimen from open biopsy or core needle aspirate, or paraffin block); 4. The patient is =18 years old; 5. Female patient, must be at least 1 year postmenopausal or surgically sterilized, or be sexually abstinent or have a sterile sexual partner, or have continuously taken oral contraceptives 4 weeks prior to the PTS treatment and take oral contraceptives continuously 30days after the PTS treatment, implantable or injectable contraceptives, an approved form of contraceptives (including intrauterine device, female condom, diaphragm with spermicide, cervical cap, or use of a condom by sexual partner). Female patient of childbearing potential must pass a negative pregnancy test; 6. The patient's ECOG Performance Status is 0 to 3; 7. The patient's life expectancy is greater than 3 months; 8. The patient is able to tolerate localized injections of PTS; 9. The patient has adequate bone marrow, renal, and hepatic function as evidenced by: . Total WBC count=3000/mm3; . platelet count=75,000/mm3; . creatinine=2.0 mg/dL,or creatinine clearance=60 mL/min; . total bilirubin=2.0 mg/dL; . SGOT and SGPT=2 .5x ULN, and . alkaline phosphatase=5 x ULN; 10. Negative for HIV test; 11. The patient is capable of understanding and complying with the protocol and has signed the informed consent document.
Exclusion criteria
Exclusion criteria: 1. The target lesion is adjacent to any essential blood vessel, nerves or organs is not applicable for this injection treatment; 2. The patient has a serious concomitant medical condition including an active uncontrolled infection or serious functional disorders of the heart, liver, kidneys, or blood; 3. The patient is pregnant or lactating; 4. The patient has a known hypersensitivity to PTS or related compounds; 5. The patient has treated with systemic anticancer therapy less than 4 weeks or treated by a systemic therapy contained a Nitrosourea or Mitomycin-C within 6 weeks; 6. The patient has participated in clinical studies of non-approved experimental agents or procedures within 4 weeks prior to study entry; 7. The patient has a history of malignancies other than the study malignancy, unless the patient was curatively treated and has been disease free for greater than 2 years; 8. patient with the same kind or the history of xenotransplantation; 9. The patient has had radiation performed on the target tumor lesion within 4 weeks; 10. Patient is suffering from any other life-threatening complications; 11. The patient is unwilling to comply with study procedures, as specified by this protocol, or is unwilling to cooperate fully with the investigator; 12. Any other reasons rationalized by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Evaluation (RECIST & WHO Standard);Evaluate the histologic and pathologic changes of tumor tissue & connected adjacent normal tissue; | — |
Secondary
| Measure | Time frame |
|---|---|
| ECOG;QOL;Safety Evaluation; | — |
Countries
China
Contacts
Public ContactGuang-Wei Xu
Outcome results
None listed