PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy

Sponsor

PhytoHealth Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT01696565

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objectives of this Phase I/II study are:

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.
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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasm Metastasis Neoplasm Recurrence	Drug: PG2	Phase 1/Phase 2

Detailed Description

This study is the first step for PG2 clinical development in Taiwan in order to further establish its safety and efficacy profile and to build the basis for larger trials.

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy

Actual Study Start Date :

Dec 1, 2001

Actual Primary Completion Date :

Oct 1, 2003

Actual Study Completion Date :

Oct 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 125 mg/day Treatment Arm 125 mg/day PG2 treatment continuously for 7 days	Drug: PG2 Injectable
Experimental: 250 mg/day Treatment Arm 250 mg/day PG2 treatment continuously for 7 days	Drug: PG2 Injectable
Experimental: 500 mg/day Treatment Arm 500 mg/day PG2 treatment continuously for 7 days	Drug: PG2 Injectable

Arm

Intervention/Treatment

Experimental: 125 mg/day Treatment Arm

125 mg/day PG2 treatment continuously for 7 days

Drug: PG2

Injectable

Experimental: 250 mg/day Treatment Arm

250 mg/day PG2 treatment continuously for 7 days

Drug: PG2

Injectable

Experimental: 500 mg/day Treatment Arm

500 mg/day PG2 treatment continuously for 7 days

Drug: PG2

Injectable

Outcome Measures

Primary Outcome Measures

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 [within 14 days of each chemotherapy cycle]
For phase I study, the primary endpoint is to determine a safe dosage of PG2 by the dose escalation design. For phase II study, the primary endpoint is to compare the WBC level between PG2 plus chemotherapy and chemotherapy alone.

Secondary Outcome Measures

Phase II: To use the study dose to assess the hematopoietic and immunological cytokine levels [within 14 days of each chemotherapy cycle]
For phase II study, the secondary endpoint is to compare the levels of IL-2, IL-6, TGF-beta and G-CSF between PG2 plus chemotherapy and chemotherapy alone.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).