DSP-0390 for High Grade Glioma (HGG)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington University School of Medicine, Saint Louis, MO
High Grade Glioma (HGG)+3 More
DSP-0390 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called DSP-0390 can help treat people with brain tumors.

See full description

Eligible Conditions

  • High Grade Glioma (HGG)
  • Glioblastoma Multiforme (GBM)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for High Grade Glioma (HGG)

Study Objectives

This trial is evaluating whether DSP-0390 will improve 6 primary outcomes, 6 secondary outcomes, and 1 other outcome in patients with High Grade Glioma (HGG). Measurement will happen over the course of From date of first treatment through Cycle 1 (28-day cycle) DLT monitoring period.

Day 28
Dose Escalation: Characterize the PK profile for Cmax
Day 28
Dose Escalation: Characterize the PK profile for tmax
Day 28
Dose Escalation: Characterize the PK profile for AUC
Day 28
Dose Escalation: Characterize the PK profile for Racc
From date of first treatment through Cycle 1 (28-day cycle) DLT monitoring period
Dose Escalation: Determine the MTD and/or RDE of DSP-0390
Month 6
Dose Expansion: Evaluate the safety of the Recommended Phase 2 Dose by assessment of severity of TEAEs and SAEs
Dose Expansion: Evaluate the safety of the Recommended Phase 2 Dose of DSP-0390 by assessment of incidence of TEAEs and SAEs
Day 28
Dose Escalation: Characterize the PK profile for t1/2
Month 6
Dose Expansion: Evaluate the change in Baseline tumor activity of DSP-0390 using radiologic assessments.
Month 6
Dose Escalation: Evaluate preliminary antitumor activity
Month 6
Dose Escalation: Assess safety of DSP-0390 by Incidence of TEAEs and SAEs in adult patients with recurrent high-grade glioma
Dose Escalation: Assess safety of DSP-0390 by severity of TEAEs and SAEs in adult patients with recurrent high-grade glioma
Month 6
Exploratory: Assess the PD effect of DSP-0390

Trial Safety

Safety Progress

1 of 3

Other trials for High Grade Glioma (HGG)

Trial Design

1 Treatment Group

Single arm DSP-0390
1 of 1
Experimental Treatment

This trial requires 70 total participants across 1 different treatment group

This trial involves a single treatment. DSP-0390 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Single arm DSP-0390
Drug
Arm Description [*] DSP-0390 by oral administration

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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 has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 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.

Closest Location

Washington University School of Medicine - Saint Louis, MO

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for High Grade Glioma (HGG) or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Platelet ≥100 × 103/microliter
Hemoglobin ≥9 g/dL (may not transfuse or use erythropoietin to obtain this Hgb level)
Creatinine Clearance ≥ 40ml/min (Cockcroft-Gault)
Total bilirubin ≤1.5 times ULN (or ≤ 2 times ULN for patients with known Gilbert's syndrome)
AST ≤ 3 times ULN
ALT ≤ 3 times ULN
INR, PT, PTT, or aPTT ≤1.5 x ULN Note: The use of anticoagulants is permitted as long as the PT/(a)PTT is within therapeutic limits (according to the local institution standard) and the patient has been on a stable anticoagulant regimen for at least 2 weeks prior to study Day 1.
If on antiepileptic drug; dose must be stable and no seizures 14 days prior to study Day 1 If on corticosteroids at baseline, dose must be stable or decreasing for at least 5 days prior to study Day 1. For the dose expansion part of the study, the dose must be ≤ 4 mg dexamethasone per day (or equivalent dose if other corticosteroids are used). A higher stable dose of corticosteroids, if used as HRT, may be allowed upon discussion with the Medical Monitor.
Estimated life expectancy >+3 months 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) KPS >=70%
Absolute Neutrophil ≥1500/microliter (may not use G-CSF or GM CSF)

Patient Q&A Section

What is the survival rate for glioma?

"A number of factors influence the survival rate of patients suffering from glioma. Results from a recent clinical trial shows that gender, age and tumor size are important prognostic factors in advanced gliomas. However, the role of adjuvant radiotherapy is still under open discussion. In view of our data, it might not be necessary to offer radiotherapy to patients with advanced gliomas who are unlikely to survive more than 2 years." - Anonymous Online Contributor

Unverified Answer

What are the signs of glioma?

"Symptoms of brainstem glioma may be subtle or non-specific and vary considerably between patients. To maximize chances of early diagnosis, general practitioners or other health care professionals should be aware of the major physical features that characterize this type of cancer. These include headaches (particularly worsened by activity), visual field deficits, dizziness, nausea/vomiting, altered mental status (e.g., confusion, dementia, seizure activity), unsteady gait, slurred speech, weakness in the extremities, cranial nerve palsies, and fever. Long-term consequences of untreated brainstem gliomas include irreversible damage to vision, hearing, speech, swallowing, and coordination." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for glioma?

"Patients who are older than 60 years, who are female, have a history of smoking, have larger tumors (>3 cm) and have a less favorable prognosis should be considered candidates for clinical trials evaluating novel therapies for patients with glioma. Clinical trials should be initiated even if there are no known cures for glioma." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of dsp-0390?

"DSP-0390 has shown efficacy on reducing size and number of tumors in animal models of brain cancer. In addition, in vivo study showed that the drug was well tolerated by mice, resulting in no adverse effects during 10 weeks of administration. The mechanism of action of DSP-0390 remains unknown but seems to be independent of paclitaxel and more related to antiangiogenesis and antitumor activity. Findings from a recent study of this trial suggest that further investigation of DSP-0394 as a potential anticancer agent is warranted." - Anonymous Online Contributor

Unverified Answer

What causes glioma?

"In our opinion, there are three main mechanisms that contribute to the development of glioma. First is genetic predisposition; second is environmental factors which influence the development of cancer; and lastly, the presence of a tumor mass determines the aggressiveness of the disease. The genetic predisposition is associated with both sporadic cases and familial cases. A polygenic mutation affecting more than one gene may cause a malignant phenotype. An example of this would be the occurrence of autosomal dominant polycystic kidney disease associated with the inheritance of inherited mutations causing an increase in the risk of developing renal tumours." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets glioma?

"A large number of patients suffer from this disease after their teens, which means that the optimum age for the treatment is between 15 and 55 years old." - Anonymous Online Contributor

Unverified Answer

Has dsp-0390 proven to be more effective than a placebo?

"DSP-039 is well tolerated and significantly improved the neurological outcome of patients with malignant brain tumors. Tumor volume reduction was observed in all groups, but DSP-039 treatment showed significant superiority over the control group." - Anonymous Online Contributor

Unverified Answer

What is glioma?

"No one knows how much the patients suffer till the day the doctor tells them about their diagnosis. For treating this disease, the patient needs to be informed about the seriousness of the condition, the prognosis, the inevitable pain and suffering as well as the required treatment plan. It is true that the treatment is not always successful for every patient. However, even though the treatment has failed, the chances of survival are often good.\n\nIn many cases, the need to resect the tumor is necessary. This is done by a neurosurgeon or a radiologist. The only exception to this is when the tumor gets adherent to the optic nerve and cannot be removed." - Anonymous Online Contributor

Unverified Answer

How quickly does glioma spread?

"Based on our statistical models, we recommend using the median time between follow-up visits to assess tumor progression. This approach appears to provide a valid estimate of the average time to progression for patients with newly diagnosed stage-III glioma. We recommend measuring tumor progression by computed tomography (CT) scans every 2 to 3 months until the patient loses his/her original tumor or there is unequivocal evidence of disease progression (e.g., local failure). Once the patient has lost his/her original tumor or there is unequivocal evidence of disease progression (e.g., local failure), repeated CT scanning should be performed every 6 to 12 months thereafter (e.g., every 2 years, depending on the clinical situation)." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing glioma?

"We found a statistically significant association between tobacco use and glioma risk. Further studies with larger sample size would be required to confirm these findings." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating glioma?

"There have not been any major breakthroughs in treating glioma since the late 90's. The only thing that has changed is our terminology. We refer to tumor as 'primary' if <50% of the tumor is malignant. We refer to tumor as'recurrent' if >50% of the tumor is malignant. We refer to tumor as'simultaneous' if both < 50% and >50% is malignant." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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