Clinical trial NCT01696565: PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy
Official title: PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Neoplasm Metastasis
Neoplasm Recurrence
Keywords: myelosuppression
chemotherapy
Astragalus membranaceus
hematopoietic response
Lead sponsor: PhytoHealth Corporation
Sponsor class: INDUSTRY
First posted: 2012-10-01
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Phase II: To use the study dose to assess the hematopoietic and immunological cytokine levels
timeFrame: within 14 days of each chemotherapy cycle
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
affiliation: Taichung Tzu Chi Hospital
name: Woei-Yao Kao, Chief
role: PRINCIPAL_INVESTIGATOR
References: