Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434077
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-23
Brief Title:
Clinical Trial Protocol Randomized Placebo-Controlled Pilot Study of GcMAF Soloways TM in Patients With Metastatic Breast Cancer
Sponsor:
SLAB SOLOWAYS
Organization:
SLAB SOLOWAYS
Study Overview
Official Title:
Clinical Trial Protocol Randomized Placebo-Controlled Pilot Study of GcMAF Soloways TM in Patients With Metastatic Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized double-blind placebo-controlled pilot study aims to evaluate the efficacy and safety of GcMAF in reducing nagalase levels and improving clinical outcomes in female patients with metastatic breast cancer over six months Sixty patients will be randomized into two groups receiving either weekly GcMAF or placebo injections The primary endpoint is the change in serum nagalase levels from baseline to six months Secondary endpoints include clinical status quality of life adverse effects and markers of inflammation and immune activity Tumor response will be assessed using RECIST criteria and quality of life will be measured with the EORTC QLQ-C30 questionnaire Immune and inflammation markers will be evaluated using flow cytometry and ELISA Adverse events will be monitored and categorized according to severity Inclusion criteria include confirmed metastatic breast cancer completion of one line of systemic therapy adequate organ function and elevated serum nagalase levels The study will involve baseline measurements monthly assessments and final evaluations to compare changes in nagalase levels and other clinical outcomes between the GcMAF and placebo groups
Detailed Description:
This randomized double-blind placebo-controlled pilot study aims to evaluate the efficacy and safety of GcMAF Gc Macrophage Activating Factor in female patients with metastatic breast cancer The primary objective is to assess the reduction in serum nagalase levels an enzyme associated with tumor activity over a six-month period and to evaluate improvements in clinical outcomes The study involves 60 patients who will be divided into two groups one receiving weekly injections of GcMAF and the other receiving a placebo
Patients eligible for the study must have histologically or cytologically confirmed metastatic breast cancer completed at least one line of systemic therapy and have elevated serum nagalase levels Additional inclusion criteria include female patients aged 18 to 70 years ECOG performance status of 0 to 2 adequate bone marrow liver and renal function and an estimated life expectancy of at least six months Patients must also agree to use effective contraception and provide informed consent
The primary endpoint is the change in serum nagalase levels from baseline to six months Measurements will be taken at baseline monthly and at the end of the study using standardized enzymatic assays Secondary endpoints include clinical status assessed through objective tumor response using RECIST criteria and performance status using the ECOG scale quality of life evaluated through EORTC QLQ-C30 questionnaires immune activity measured by flow cytometry for various immune cell subsets and inflammation markers such as CRP interleukins and TNF-alpha measured by ELISA Adverse effects will be monitored weekly and categorized according to the Common Terminology Criteria for Adverse Events CTCAE v50
The study procedures include initial screening to measure baseline nagalase levels and assess eligibility followed by randomization into the GcMAF or placebo groups Patients will receive weekly injections for six months with monthly assessments of nagalase levels clinical status quality of life and blood samples for immune and inflammation markers Interim assessments will occur at three months with final assessments and data analysis at six months
Exclusion criteria include the presence of other active malignancies severe uncontrolled illnesses pregnancy or breastfeeding previous treatment with GcMAF and known hypersensitivity to the study drug components The study timeline consists of patient recruitment and baseline measurements in the first month followed by six months of treatment and monitoring with interim and final assessments and subsequent data analysis
This study aims to determine if GcMAF can significantly reduce serum nagalase levels and improve clinical outcomes including tumor response performance status quality of life and immune and inflammation markers in patients with metastatic breast cancer The results will provide insight into the potential therapeutic benefits of GcMAF for this patient population
Patients eligible for the study must have histologically or cytologically confirmed metastatic breast cancer completed at least one line of systemic therapy and have elevated serum nagalase levels Additional inclusion criteria include female patients aged 18 to 70 years ECOG performance status of 0 to 2 adequate bone marrow liver and renal function and an estimated life expectancy of at least six months Patients must also agree to use effective contraception and provide informed consent
The primary endpoint is the change in serum nagalase levels from baseline to six months Measurements will be taken at baseline monthly and at the end of the study using standardized enzymatic assays Secondary endpoints include clinical status assessed through objective tumor response using RECIST criteria and performance status using the ECOG scale quality of life evaluated through EORTC QLQ-C30 questionnaires immune activity measured by flow cytometry for various immune cell subsets and inflammation markers such as CRP interleukins and TNF-alpha measured by ELISA Adverse effects will be monitored weekly and categorized according to the Common Terminology Criteria for Adverse Events CTCAE v50
The study procedures include initial screening to measure baseline nagalase levels and assess eligibility followed by randomization into the GcMAF or placebo groups Patients will receive weekly injections for six months with monthly assessments of nagalase levels clinical status quality of life and blood samples for immune and inflammation markers Interim assessments will occur at three months with final assessments and data analysis at six months
Exclusion criteria include the presence of other active malignancies severe uncontrolled illnesses pregnancy or breastfeeding previous treatment with GcMAF and known hypersensitivity to the study drug components The study timeline consists of patient recruitment and baseline measurements in the first month followed by six months of treatment and monitoring with interim and final assessments and subsequent data analysis
This study aims to determine if GcMAF can significantly reduce serum nagalase levels and improve clinical outcomes including tumor response performance status quality of life and immune and inflammation markers in patients with metastatic breast cancer The results will provide insight into the potential therapeutic benefits of GcMAF for this patient population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None