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

Study Description

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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.

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

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Study Type :	Interventional (Clinical Trial)
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
Study Start Date :	December 2001
Actual Primary Completion Date :	October 2003
Actual Study Completion Date :	October 2003

Arms and Interventions

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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

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Primary Outcome Measures :

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 [ Time Frame: 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 :

1. Phase II: To use the study dose to assess the hematopoietic and immunological cytokine levels [ Time Frame: 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

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Ages Eligible for Study:	20 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

Taiwan
Tri-Service General Hospital
Taipei, Taiwan, 114

Sponsors and Collaborators

PhytoHealth Corporation

Investigators

Principal Investigator:	Woei-Yao WY Kao, Chief	Division of Hematology/Oncology, Tri-Service General Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	PhytoHealth Corporation
ClinicalTrials.gov Identifier:	NCT01696565 History of Changes
Other Study ID Numbers:	PH-CP002-2
First Posted:	October 1, 2012
Last Update Posted:	October 1, 2012
Last Verified:	September 2012

Keywords provided by PhytoHealth Corporation:

myelosuppression; chemotherapy; Astragalus membranaceus; hematopoietic response

Additional relevant MeSH terms:

Neoplasms; Recurrence; Neoplasm Metastasis	Disease Attributes; Pathologic Processes; Neoplastic Processes