What side effects are associated with this type of intervention?

Common treatments for glioblastoma, including chemotherapy agents like temozolomide and investigational drugs similar to Gallium Maltolate, often cause side effects such as nausea, vomiting, fatigue, and myelosuppression. Targeted therapies and drugs that disrupt iron metabolism or induce apoptosis may also lead to gastrointestinal disturbances, liver toxicity, and potential neurotoxicity.

What prior FDA approvals exist?

FDA-approved treatments for Glioblastoma include temozolomide, an oral alkylating agent that damages DNA and induces apoptosis, and bevacizumab, a monoclonal antibody that inhibits angiogenesis by targeting VEGF. While Gallium Maltolate is being studied for its ability to inhibit ribonucleotide reductase, disrupt iron metabolism, and induce apoptosis, similar mechanisms are not explicitly highlighted in the currently approved treatments. However, the focus on disrupting cellular metabolism and inducing apoptosis aligns with the general therapeutic strategies for Glioblastoma.

What other types of research exist?

Promising novel alternatives to Gallium Maltolate for Glioblastoma patients include: 1) CAR-T cell therapy targeting EGFRvIII, which involves engineering patients' T cells to attack glioblastoma cells expressing the EGFRvIII mutation. 2) Oncolytic virotherapy using genetically modified viruses like DNX-2401, which selectively infect and kill glioblastoma cells. 3) Tumor Treating Fields (TTF), a non-invasive treatment that uses electric fields to disrupt cancer cell division. 4) Immunotherapy with checkpoint inhibitors such as pembrolizumab, which helps the immune system recognize and attack cancer cells. These therapies are in various stages of clinical trials and have shown potential in improving outcomes for glioblastoma patients.

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Metal Complex

Gallium Maltolate for Glioblastoma

Phase 1

Recruiting

Led By Jennifer Connelly, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female subjects must be ≥18 years of age.

Male subjects, even if surgically sterilized, must practice effective barrier contraception or true abstinence.

Must not have

Inability to tolerate an oral medication or keep pills down.

Patients who have not completed all standard-of-care treatments including surgical procedures and radiation therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing an oral medicine called gallium maltolate in patients with brain cancer that has come back after treatment. The goal is to see if the medicine can safely stop the growth of cancer cells. Gallium maltolate has shown potential in slowing the growth of glioblastoma by disrupting iron metabolism and inhibiting mitochondrial function.

Who is the study for?

Adults diagnosed with relapsed glioblastoma who've completed standard treatments, including radiotherapy and temozolomide. They must have measurable disease or confirmed recurrence, be in fair health (ECOG 0-2), and have proper organ function. Women of childbearing potential and men must agree to contraception methods.

What is being tested?

The trial is testing different doses of oral gallium maltolate for safety and initial effectiveness in treating recurrent glioblastoma. Participants will receive one of several dose levels, including a recommended phase 2 dose determined during the study.

What are the potential side effects?

Specific side effects are not listed but may include typical reactions to oral medications such as gastrointestinal discomfort, potential liver or kidney issues based on required organ function tests, and possible interactions with iron supplements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am a man and will use effective contraception or practice abstinence.

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I can take care of myself and am up and about more than half of my waking hours.

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My cancer's progress can be measured or has been confirmed through tests.

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I have been diagnosed with GBM or my tumor has GBM-like features according to WHO standards.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot swallow or keep pills down.

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I haven't finished all recommended treatments like surgery or radiation.

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I do not have severe heart, lung diseases, or uncontrolled diabetes.

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I am not currently on any chemotherapy that kills cancer cells.

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I haven't had chemotherapy or radiotherapy in the last 14 days.

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I have a history of lung conditions like sarcoidosis or pulmonary fibrosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum-tolerated dose.

Secondary study objectives

Dose-limiting toxicity

Overall survival

Progression-free survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Dose-expansion PhaseExperimental Treatment1 Intervention

A minimum of six participants will be enrolled in the dose expansion phase for a total of 12 subjects at the recommended phase 2 dose.

Group II: Dose-escalation Phase (500 mg)Experimental Treatment1 Intervention

This is a 3 + 3 design. Participants will be entered sequentially. If 0 of 3 participants has a dose-limiting toxicity (DLT), new participants may be entered at the next higher dose level. If 1 of 3 participants has a DLT, up to 3 more participants are to be treated at that same dose level. If 0 of the additional 3 participants at that dose level has a DLT, new participants may be entered at the next higher dose level. If 1 or more of the additional 3 participants experience a DLT, 0 participants are to be started at that dose level and the preceding dose is the maximum-tolerated dose (MTD). If 2 of 3 of the dosed participants has a DLT on the first dose level, the drug will be administered at a lower dose. If 0 of 3 participants has a DLT at the highest dose level, an additional 3 participants will be enrolled to ensure that 6 participants are treated at the MTD. The MTD is the highest dose level at which no more than 1 of 6 treated participants, experiences a DLT.

Group III: Dose-escalation Phase (2,500 mg)Experimental Treatment1 Intervention

Group IV: Dose-escalation Phase (2,000 mg)Experimental Treatment1 Intervention

Group V: Dose-escalation Phase (1,500 mg)Experimental Treatment1 Intervention

Group VI: Dose-escalation Phase (1,000 mg)Experimental Treatment1 Intervention

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Glioblastoma include surgery, radiation therapy, and chemotherapy with agents like temozolomide. Temozolomide works by methylating DNA, which leads to apoptosis in rapidly dividing tumor cells. Radiation therapy damages the DNA of cancer cells, also promoting cell death. Gallium Maltolate, an investigational treatment, inhibits ribonucleotide reductase, disrupts iron metabolism, and induces apoptosis, which are crucial mechanisms for targeting the metabolic vulnerabilities of Glioblastoma cells. These treatments matter for Glioblastoma patients as they aim to reduce tumor burden, slow disease progression, and improve survival outcomes by exploiting the unique biological characteristics of the tumor.