PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy (NCT01696565) | Clinical Trial Compass
CompletedPhase 1/2
PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy
Taiwan32 participantsStarted 2001-12
Plain-language summary
The objectives of this Phase I/II study are:
1. To find out the maximum tolerated dose (MTD) of PG2 in patients with advanced malignancy receiving chemotherapy and to define a "Study Dose" for Phase II.
2. To evaluate the hematopoietic and immunological responses after administering of PG2. Primarily to study the biological response of PG2, defined as WBC count in this study, and secondarily to study the immunological factors, IL-2, IL-6, TGF-beta, and G-CSF.
Who can participate
Age range
20 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient must have malignancy with metastatic or recurrent diseases.
* Patient must have a minimum of thirteen days period elapsed from any previous chemotherapy or radiotherapy and all treatment-related toxicities subsided.
* Patient must have at least 2 courses of chemotherapy treatment left, and a minimum of 13 days between the administration of the last dose of the chemotherapy with PG2 and the start of the next course of chemotherapy.
* Performance status is 0-2 by ECOG scale.
* Patient's compliance and geographic proximity that allow adequate follow up.
* Adequate bone marrow function before the chemotherapy
* Adequate liver and renal function before the chemotherapy
* Written informed consent from patients
* Woman with childbearing potential should use contraception method through the whole PG2 treatment course.
* After the previous course of chemotherapy, the nadir of WBC dropped between 1000 to 3000/ mm3 (for phase II only).
Exclusion Criteria:
* PG2 skin test is positive.
* Active infection
* Breast feeding
* Prior radiotherapy more than 30% of the bone marrow involved.
* Pregnant woman
* Bone marrow transplantation or brain disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase I: To find the maximum tolerated dose (MTD) or the highest tolerated dose (HTD) as the study dose of PG2; Phase II: To use the study dose and assess the WBC level of PG2
Timeframe: within 14 days of each chemotherapy cycle