Potentiation of Chemotherapy in Brain Tumors by Zinc

NCT04488783 | Unknown DMC

• 1 other identifier: 4266-17-SMC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Newly Diagnosed Glioblastoma Who Underwent at Least Partial Resection of the Tumor Surgically

Keywords

GBM; glioblastoma; zinc; vitamin C

Outcome Measures

Primary Outcomes (2)

• progression free survival (PFS)

  year 1

• overall survival (OS)

  year 2

Secondary Outcomes (3)

• Tcell count

  year 2

• Level of Interleukin 6

  year 2

• Tumor Necrosis Factor quantification

  year 2

Study Arms (1)

Glioblastoma patients

EXPERIMENTAL

newly diagnosed GB who underwent at least partial resection of the tumor surgically

Dietary Supplement: zinc and ascorbate

Interventions

zinc and ascorbate DIETARY_SUPPLEMENT

oral zinc and ascorbate

Glioblastoma patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

Zinc

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Central Study Contacts

Ruty Shai, PhD

CONTACT

972-543938318; ruty.shai@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 28, 2020
• Study Start: July 30, 2020
• Primary Completion: July 30, 2022
• Study Completion: December 30, 2022
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)