- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04488783
Potentiation of Chemotherapy in Brain Tumors by Zinc
July 27, 2020 updated by: Dr. Leor Zach, MD, Sheba Medical Center
Glioblastoma (GB) is the most common and aggressive type of primary malignant brain tumor in adults.
Despite advances in surgical resection, radiotherapy and chemotherapy, prognosis remains very poor.
Temozolomide (TMZ) as an alkylating agent has become part of GBM management but it has contributed only marginally to prolongation of life in GBM patients.
Our aim is to evaluate the therapeutic potential of the trace element zinc to facilitate temozolomide tumor cell toxicity in GBM.
P53 gene is inactive/mutant in most of these patients which may affect the resistance to apoptosis of tumor cells by chemotherapy.
Zinc (Zn) has a crucial role in the biology of p53, in that p53 binds to DNA through a structurally complex domain stabilized by zinc atom.
We have shown that the cytotoxic activity of TMZ is substantially increased with the addition of zinc in vitro with GBM cell lines as well as in vivo, with intracranial GBM xenografts.
Numerous studies of zinc in animal models and in human subjects support its use in the treatment and possibly the prevention of cancer.
Zinc has been consumed by the public as an essential mineral (and thus is category A drug) in concentrations which allows this effect with Temozolomide.
Vitamin C could add to this by priming the immune system for lymphocyte- linked cancer killing.
The vitamin c increases the number of tumor infiltrating lymphocytes and enhances the activation of the immune system.We propose a single arm phase II clinical trial in 30 newly diagnosed GBM patients who will be treated with the standard chemo-radiotherapy with the addition of zinc and vitamin C.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
We propose a single arm phase II clinical trial in 30 newly diagnosed GBM patients who will be treated with the standard chemo-radiotherapy with the addition of daily zinc.
We will follow the toxicity, Progression free survival and overall survival of this group of patients.
We hope to demonstrate the anti-tumor activity of zinc that will enhance the activity of temozolomide chemotherapy in adult glioblastoma patients.
We will also follow the safety and monitor quality of life during treatment.
In this study, we will compare results of patients receiving zinc to historical patient data.
We will review patient portfolios with GB tumors that received treatment as the subjects in this study in the last five years before the study began.
Collecting the data and separating the identified data from the file in a way that cannot be retrieved in any way will be done by a staff member from Dr Ruty Shai's laboratory who is authorized to open medical files.
We will adjust the age and number of patients in each gender.
Data collected: date of birth, age of disease development, gender, data after receiving treatment: Progression free survival and overall survival of this group of patients, side effects, and quality of life.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ruty Shai, PhD
- Phone Number: 972-543938318
- Email: ruty.shai@sheba.health.gov.il
Study Locations
-
-
-
Ramat Gan, Israel
- Recruiting
- Sheba Medical Center
-
Contact:
- Ruty Shai, Ph.D
- Phone Number: 972543938318
- Email: ruty.shai@sheba.health.gov.il
-
Principal Investigator:
- Ruty Shai, Ph.D
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 88 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males and Females,
- age ≥ 18 years old,
- newly diagnosed GBM, Karnofsky performance status of ≥ 70,
- after partial resection or gross tumor resection (GTR) who recovered from surgical resection.
Exclusion Criteria:
- GB patients with less than 20% of tumor removed,
- Prior treatment for GB (other than surgical resection),
- any known malignancy outside of the brain in the last 5 years,
- in ability to swallow drugs.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Glioblastoma patients
newly diagnosed GB who underwent at least partial resection of the tumor surgically
|
oral zinc and ascorbate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progression free survival (PFS)
Time Frame: year 1
|
year 1
|
overall survival (OS)
Time Frame: year 2
|
year 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tcell count
Time Frame: year 2
|
Blood test
|
year 2
|
Level of Interleukin 6
Time Frame: year 2
|
Interleukin 6 and Tumor Necrosis Factor quantification
|
year 2
|
Tumor Necrosis Factor quantification
Time Frame: year 2
|
Blood test
|
year 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 30, 2020
Primary Completion (Anticipated)
July 30, 2022
Study Completion (Anticipated)
December 30, 2022
Study Registration Dates
First Submitted
July 22, 2020
First Submitted That Met QC Criteria
July 27, 2020
First Posted (Actual)
July 28, 2020
Study Record Updates
Last Update Posted (Actual)
July 28, 2020
Last Update Submitted That Met QC Criteria
July 27, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4266-17-SMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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