What side effects are associated with this type of intervention?

Common treatments for high-grade gliomas, including chemotherapy (e.g., temozolomide), radiotherapy, and novel agents like DSP-0390, often have side effects such as headache, nausea, fatigue, and skin reactions. Chemotherapy can also cause hematologic toxicity, including low blood counts, and gastrointestinal issues. Radiotherapy may lead to neurocognitive decline and localized hair loss. Novel agents targeting specific pathways may have unique side effects, such as muscle cramps, loss of taste, and weight loss, as seen with vismodegib in other cancer treatments.

What prior FDA approvals exist?

The FDA has approved several treatments for brain tumors, particularly glioblastomas. Notable approvals include temozolomide, an oral alkylating agent, and bevacizumab, a monoclonal antibody targeting VEGF to inhibit angiogenesis. Additionally, Tumor Treating Fields (TTF) therapy, a novel modality using electric fields to disrupt cancer cell division, has been approved. These treatments represent a range of approaches from chemotherapy to targeted and novel therapeutic modalities, similar to the investigational agent DSP-0390.

What other types of research exist?

Promising novel alternatives to DSP-0390 for brain tumor patients include: 1) Ivosidenib, a mutant-IDH1 inhibitor, which has shown efficacy in IDH1-mutant gliomas with a good safety profile. 2) Vorasidenib, a dual mutant-IDH1/2 inhibitor, currently in phase III testing for IDH1/2-mutant gliomas. 3) Bevacizumab, an anti-angiogenic agent, which has shown efficacy in reducing tumor growth and improving hearing in NF2-related vestibular schwannomas. 4) Everolimus, an mTORC1 inhibitor, which has demonstrated potential in treating progressive vestibular schwannomas and meningiomas. These therapies represent promising options for brain tumor patients considering treatment in 2024.

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DSP-0390 for Brain Tumor

Q: What is the mechanism of action of this treatment?

Common treatments for brain tumors, particularly high-grade gliomas, include chemotherapy, targeted therapy, and radiation therapy. Chemotherapy agents like temozolomide work by damaging the DNA of rapidly dividing tumor cells, leading to cell death. Targeted therapies, such as bevacizumab, inhibit specific molecules involved in tumor growth and angiogenesis, thereby starving the tumor of nutrients and slowing its progression. Radiation therapy uses high-energy beams to destroy tumor cells and shrink tumors. These treatments are crucial for brain tumor patients as they aim to control tumor growth, alleviate symptoms, and improve survival rates. Novel agents like DSP-0390 are being studied to target specific pathways in tumor cells, potentially offering more effective and personalized treatment options.

Phase < 1

Waitlist Available

Research Sponsored by Sumitomo Dainippon Pharma Oncology, Inc

Eligibility Criteria Checklist

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

Must have

KPS >=70%

Recovery from toxic effects of prior therapy to NCI CTCAE v5.0 Grade 1 (non-hematologic toxicities) or Grade <=2 (hematologic toxicities, except deep vein thrombosis)

Must not have

Prior therapy with bevacizumab or other anti-vascular endothelial growth factor (VEGF) treatments within 3 months prior to study Day 1

Presence of any active retinal abnormality

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cycle 1 day 1 and cycle 2 day 1- 0, 30 min, and 1, 2, 4, 6, 8, 10, 12 hrs , each cycle is 28 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called DSP-0390 in patients with a type of brain cancer that has returned after treatment. The goal is to see if this drug can help stop or slow down the cancer.

Who is the study for?

This trial is for adults with recurrent high-grade glioma who have a good performance status, stable organ function, and no recent major surgeries or other cancer treatments. They must not have certain heart conditions, active infections (HIV/HCV/HBV), significant eye abnormalities, uncontrolled illnesses that could affect study participation, or be on conflicting medications. Women of childbearing potential and men must agree to use contraception.

What is being tested?

The trial is testing DSP-0390 in patients with recurrent high-grade brain tumors like glioblastoma. It aims to see how effective this drug is in treating the tumor and what side effects it may cause.

What are the potential side effects?

While specific side effects of DSP-0390 are not listed here, common ones for cancer drugs include nausea, fatigue, risk of infection due to low blood cell counts, liver issues indicated by altered blood tests results and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am mostly able to care for myself and carry out daily activities.

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I have recovered from previous cancer treatment side effects.

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My blood counts and organ functions are within the required ranges.

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My epilepsy medication dose has been stable and I've had no seizures for 14 days.

Exclusion Criteria

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

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I haven't had treatments targeting blood vessel growth in the last 3 months.

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I have an active eye condition affecting my retina.

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My cancer has spread to multiple areas, including the brain's lining or beyond.

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I do not have significant heart issues, swallowing disorders, or severe digestive conditions.

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I haven't had major surgery or significant heart disease issues in the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cycle 1 day 1 and cycle 2 day 1 -0, 30 min, and 1, 2, 4, 6, 8, 10, 12 hrs , each cycle is 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cycle 1 day 1 and cycle 2 day 1 -0, 30 min, and 1, 2, 4, 6, 8, 10, 12 hrs , each cycle is 28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 day 1 and cycle 2 day 1 -0, 30 min, and 1, 2, 4, 6, 8, 10, 12 hrs , each cycle is 28 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Assess safety of DSP-0390 by Incidence of AEs resulting in study discontinuation in adult patients with recurrent high-grade glioma consented under Protocol Amendment 5

Assess safety of DSP-0390 by Incidence of SAEs in adult patients with recurrent high-grade glioma consented under Protocol Amendment 5

Dose Escalation: Assess safety of DSP-0390 by Incidence of TEAEs and SAEs in adult patients with recurrent high-grade glioma

+5 more

Secondary study objectives

Dose Escalation: Characterize the PK profile for AUC

Dose Escalation: Characterize the PK profile for Cmax

Dose Escalation: Characterize the PK profile for Racc

+3 more

Other study objectives

Exploratory: Assess the PD effect of DSP-0390

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single arm DSP-0390Experimental Treatment1 Intervention

Arm Description \[\*\] DSP-0390 by oral administration

0 / 9Eligibility 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 brain tumors, particularly high-grade gliomas, include chemotherapy, targeted therapy, and radiation therapy. Chemotherapy agents like temozolomide work by damaging the DNA of rapidly dividing tumor cells, leading to cell death. Targeted therapies, such as bevacizumab, inhibit specific molecules involved in tumor growth and angiogenesis, thereby starving the tumor of nutrients and slowing its progression. Radiation therapy uses high-energy beams to destroy tumor cells and shrink tumors. These treatments are crucial for brain tumor patients as they aim to control tumor growth, alleviate symptoms, and improve survival rates. Novel agents like DSP-0390 are being studied to target specific pathways in tumor cells, potentially offering more effective and personalized treatment options.

Mechanism of anti-glioma activity and in vivo efficacy of the cannabinoid ligand KM-233.Low-grade gliomas: clinical and pathobiological aspects.