Overview

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be withdrawn by the subject at any time without prejudice to future medical care.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.