Phase I, Dose-Escalation Study of Soluble Beta-Glucan (SBG) in Patients With Advanced Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-01

Study Completion Date

2016-04-20

Brief Summary

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Soluble Beta-Glucan (SBG) is a compound prepared from commercial active dry Baker's yeast which is then proceeded through a multi-step laboratory processes invented by Prof. Rapepun Wititsuwannakul, Faculty of Science, Prince of Songkla University, Thailand. Based upon pre-clinical data, SBG has been shown to inhibit angiogenesis and probably enhance immune function, leading to shrinkage of tumor size in athymic nude mice injected by hepatocellular carcinoma cells (HepG2) and cervical cancer cells. Therefore, the investigators expect to see the safety and anti-cancer property of SBG in patients with advanced cancer whom no available therapy can be offered.

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Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SBG

Group Type EXPERIMENTAL

SBG

Intervention Type DRUG

Interventions

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SBG

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of histologically or cytologically documented, advanced-stage, primary or metastatic solid tumors that are refractory to standard therapy or for which no available standard therapy exists.
* Evidence of measurable or evaluable disease.
* Age must be at least 18 years.
* ECOG performance status must be 0 or 2.
* Received only best supportive care.
* Patient must meet protocol-specified laboratory values.

Exclusion Criteria

* Second primary cancer diagnosed within 5 years, except cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma which completed curative treatment.
* Concurrent therapy with any other investigational agent.
* Severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study-drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, make the subject inappropriate for this study.
* Allergy to study drug.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No