Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma

• Status: Not yet recruiting
• Trial end date: 2026-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 1 investigational study to assess the safety and preliminary efficacy of oral gallium maltolate (GaM) in participants with relapsed glioblastoma (GBM).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical College of Wisconsin

Criteria

Inclusion Criteria:

1. Voluntary written consent must be obtained before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

2. All participants must have a prior histological diagnosis of GBM (WHO Grade IV).

3. Participants have previously undergone standard treatment with radiation and/or chemotherapy and/or surgical resection. These treatments must be completed at least two weeks prior to GaM administration. There is no maximum limit to the amount of chemotherapy or radiation participants have received.

4. Participants must have measurable disease that can be assessed for response to treatment as defined by the Response Assessment in Neuro-Oncology (RANO) criteria which incorporates MRI assessment and clinical factors.

5. Male or female subjects ≥18 years to ≤ 75 years.

6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

7. Patients must have adequate bone marrow function as evidenced by:

• an absolute neutrophil count (ANC) of >1500/µL (stable off any growth factor within 1 weeks of study drug administration

• hemoglobin > 9 g/dL

• platelet count > 100.000/µL without transfusion within one week

8. Participants must have adequate hepatic and renal function based on the following laboratory tests:

• Alanine Aminotransferase (ALT) ≤ 2 x upper limit of normal (ULN)

• Aspartate Aminotransferase (AST) ≤ 2 x ULN

• Alkaline phosphatase ≤ 2 x ULN

• Total bilirubin ≤ 2 x ULN

• Creatinine < 1.5 mg/dL or Glomerular Filtration Rate (GFR) by Modification of Diet in Renal Disease Study (MDRD) > 45

9. Patients must have adequate lung function at baseline. Spirometry measurements should be:

• Forced Vital Capacity (FVC) >70% of predicted

• Forced Expiratory Capacity in one second (FEV1) >70% of predicted

• Diffusion Capacity (DLCO) >60% of predicted

10. Female participants must meet one of the following:

• Postmenopausal for at least one year before enrollment, OR

• Surgically sterile (i.e., undergone a hysterectomy or bilateral oophorectomy), OR

• If participant is of childbearing potential (defined as not satisfying either of the above two criteria), agree to practice two acceptable methods of contraception (combination methods require use of two of the following: diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge, male or female condom, hormonal contraceptive) from the time of signing of the informed consent form through 21 days after the last dose of study agent, OR

• Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable contraception methods.) 9.

11. Male participants, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following:

• Practice effective barrier contraception during the entire study period and through 60 calendar days after the last dose of study agent, OR

• Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)

12. Patients taking oral iron supplements or iron chelators must discontinue these medications at least one week prior to starting GaM since these agents may impact on the efficacy of GaM. Drug-drug interactions between GaM and other concomitant medications have not been reported.

Exclusion Criteria:

1. Presence of other active malignant disease diagnosed within 12 months, with the exception of adequately treated non-melanoma skin cancer, adequately treated melanoma grade 2 or less, or cervical intraepithelial neoplasia. Active malignancy is malignancy receiving treatment.

2. Prior chemotherapy or radiotherapy within 14 days of study entry.

3. Known hypersensitivity to or intolerance to gallium-based medications.

4. Concurrent use of cytotoxic chemotherapy is not permitted.

5. Unstable or severe concurrent medical conditions such as severe heart (New York Heart Association Class 3 or 4) or known lung (FEV <50%) disease, uncontrolled diabetes mellitus.

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

7. Inability to tolerate an oral medication or keep pills down.

8. Participants who are pregnant or nursing.

9. Participants with any condition which, in the investigator's opinion, makes the participant unsuitable for study participation.