GlioblastomaEarly Phase 1NCT07515924
Oral Gallium Maltolate for Recurrent Glioblastoma
A Early Phase 1 study testing Gallium Maltolate and Surgical Intervention in people with Glioblastoma, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This is a Phase 0 investigational study to assess the central nervous system penetration and tumoral concentration of gallium in patients with recurrent glioblastoma administered with preoperative gallium maltolate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Gallium Maltolate and Surgical Intervention
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2027to Mar 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- 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of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- All subjects must have a prior histological diagnosis of Glioblastoma (GBM) (WHO grade IV) or molecular features of GBM (per the 6th volume of Central Nervous System Tumors in the 5th edition of the WHO Classification of Tumors).
- Subjects are required to have received standard treatment which consists of radiotherapy and temozolomide (i.e., the Stupp Protocol). Treatment with adjuvant temozolomide must be completed at least four weeks prior to GaM administration to avoid potential for overlapping toxicity with GaM. Although the half-life (T½) of temozolomide is 1.8 hours and it would be expected to be cleared by five half-lives, some patients receiving temozolomide may experience a delayed suppression of their absolute neutrophil count (ANC). Hence, a four-week interval between completion of temozolomide and GaM will be required. There is no maximum limit to the amount of chemotherapy or radiation patients have received prior to enrollment.
- Subjects must be symptomatically stable, without new or rapidly worsening neurologic deficits for a minimum of 14 days prior to screening.
- Subjects must have been reviewed by a multidisciplinary group comprised of Central Nervous System oncology experts (which could include neuro-oncology, radiation oncology, neurosurgery, and radiology) to have radiographic signs of tumor progression (as defined by the RANO criteria) requiring surgical pathologic specimen (stereotactic biopsy or craniotomy for debulking/resection).
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Subjects must have adequate bone marrow function as evidenced by:
- an ANC of >1500/μL (stable off any growth factor within one week of study drug administration)
- Hemoglobin > 9 g/dL
- Platelet count > 100,000/μL without transfusion within one week
- Subjects 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 (MDRD) > 45
- Female subjects 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 subject 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.)
- Male subjects, 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 subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
- Subjects 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.
Who cannot join
- 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.
- Prior chemotherapy or radiotherapy within 14 days of study entry.
- Known hypersensitivity to or intolerance to gallium-based medications.
- Concurrent use of cytotoxic chemotherapy is not permitted.
- Unstable or severe concurrent medical conditions such as severe heart (New York Heart Association Class 3 or 4) or known lung (forced expiratory volume (FEV) <50%) disease, uncontrolled diabetes mellitus.
- History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis, or symptomatic pleural effusion.
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- Subjects who have not completed all standard-of-care treatments including surgical procedures and radiation therapy.
- Subjects with new or worsening neurologic deficits that would require surgical treatment before complete administration of the study drug.
- Inability to tolerate an oral medication or keep pills down.
- Subjects who are pregnant or nursing.
- Subjects with any condition which, in the investigator's opinion, makes the patient unsuitable for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Medical College of Wisconsin Cancer Center Clinical Trials Office contact
United States1 site
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Rupen Desai, MD, 414-955-0950, rdesai@mcw.edu
About this study
Official title: A Phase 0 Clinical Trial of Oral Gallium Maltolate for Recurrent Glioblastoma
This is a Phase 0 investigational study to assess the central nervous system penetration and tumoral concentration of gallium in patients with recurrent glioblastoma administered with preoperative gallium maltolate.
Read the detailed description
Rationale: Currently, recruitment has concluded for a Phase 1 trial assessing in patients with GBM. Preliminary analyses have demonstrated gallium maltolate is both safe and potentially efficacious in treating glioblastoma. However, while gallium maltolate has been well-tolerated, further correlative analyses are necessary to confirm the drug's ability to act within the brain.
- Conditions
- Glioblastoma
- Being tested
- Gallium Maltolate, Surgical Intervention
- Keywords
- glioblastoma, Gallium Maltolate
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gallium MaltolateDrug
Also called CAS 108560-70-9
Gallium Maltolate will be administered at a total daily dose of 2500 mg.
Surgical InterventionProcedure or surgery
Patients will be scheduled for surgical intervention (needle biopsy or resection) as deemed necessary by the clinical team after 14 ± 5 days of oral Gallium Maltolate administration.
| Study group | Role | What they receive |
|---|---|---|
| Gallium Maltolate | Experimental | Gallium Maltolate will be administered on an outpatient basis. Subjects will take it for 14 days prior to surgical intervention. Receives: Drug: Gallium Maltolate; Procedure: Surgical Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glioma Tissue Difference
The difference in gallium concentration between glioma tissue resected from patients treated with gallium maltolate and matched glioma tissue from untreated patients from a tumor bank registry, matched based on age, pathology, and gender. The measure type will be mean reported with standard deviation.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study startMar 2027 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rupen Desai, MD, Medical College of Wisconsin
- Investigators
- Rupen Desai, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515924
- Sponsor's protocol ID
- IIT-DESAI-GBM-GALLIUMMALTOLATE
- Status last verified
- Sep 2026
- First submitted
- 31 Mar 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 0 Clinical Trial of Oral Gallium Maltolate for Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT07515924
- Acronym / sponsor ID
- IIT-DESAI-GBM-GALLIUMMALTOLATE
- Conditions
- Glioblastoma
- Keywords
- glioblastoma, Gallium Maltolate
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Mar 2027 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 0 investigational study to assess the central nervous system penetration and tumoral concentration of gallium in patients with recurrent glioblastoma administered with preoperative gallium maltolate.
Detailed description
Rationale: Currently, recruitment has concluded for a Phase 1 trial assessing in patients with GBM. Preliminary analyses have demonstrated gallium maltolate is both safe and potentially efficacious in treating glioblastoma. However, while gallium maltolate has been well-tolerated, further correlative analyses are necessary to confirm the drug's ability to act within the brain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gallium Maltolate | Experimental | Drug: Gallium Maltolate, Procedure: Surgical InterventionGallium Maltolate will be administered on an outpatient basis. Subjects will take it for 14 days prior to surgical intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Age >18 years
- 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.
- All subjects must have a prior histological diagnosis of Glioblastoma (GBM) (WHO grade IV) or molecular features of GBM (per the 6th volume of Central Nervous System Tumors in the 5th edition of the WHO Classification of Tumors).
- Subjects are required to have received standard treatment which consists of radiotherapy and temozolomide (i.e., the Stupp Protocol). Treatment with adjuvant temozolomide must be completed at least four weeks prior to GaM administration to avoid potential for overlapping toxicity with GaM. Although the half-life (T½) of temozolomide is 1.8 hours and it would be expected to be cleared by five half-lives, some patients receiving temozolomide may experience a delayed suppression of their absolute neutrophil count (ANC). Hence, a four-week interval between completion of temozolomide and GaM will be required. There is no maximum limit to the amount of chemotherapy or radiation patients have received prior to enrollment.
- Subjects must be symptomatically stable, without new or rapidly worsening neurologic deficits for a minimum of 14 days prior to screening.
Key exclusion criteria (11 listed)
- 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.
- Prior chemotherapy or radiotherapy within 14 days of study entry.
- Known hypersensitivity to or intolerance to gallium-based medications.
- Concurrent use of cytotoxic chemotherapy is not permitted.
- Unstable or severe concurrent medical conditions such as severe heart (New York Heart Association Class 3 or 4) or known lung (forced expiratory volume (FEV) <50%) disease, uncontrolled diabetes mellitus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gallium MaltolateAlso: CAS 108560-70-9Gallium Maltolate will be administered at a total daily dose of 2500 mg. | Drug | Gallium Maltolate |
| Surgical InterventionPatients will be scheduled for surgical intervention (needle biopsy or resection) as deemed necessary by the clinical team after 14 ± 5 days of oral Gallium Maltolate administration. | Procedure or surgery | Gallium Maltolate |
Primary outcome
Glioma Tissue Difference
Time frame: 3 months
The difference in gallium concentration between glioma tissue resected from patients treated with gallium maltolate and matched glioma tissue from untreated patients from a tumor bank registry, matched based on age, pathology, and gender. The measure type will be mean reported with standard deviation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medical College of Wisconsin Cancer Center Clinical Trials Office contact
Rupen Desai, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gallium Maltolate and Surgical Intervention in people with Glioblastoma, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical College of Wisconsin Cancer Center Clinical Trials Office (866-680-0505 ext. 8900, cccto@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glioma Tissue Difference (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.