nanoliposomal irinotecan for Glioma

Phase-Based Estimates
1
Effectiveness
1
Safety
University of California, San Francisco, San Francisco, CA
Glioma+1 More
nanoliposomal irinotecan - Drug
Eligibility
18+
All Sexes
Eligible conditions
Glioma

Study Summary

This study is evaluating whether a new way to deliver chemotherapy to brain tumors is safe and tolerable.

See full description

Eligible Conditions

  • Glioma
  • High Grade Glioma (HGG)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether nanoliposomal irinotecan will improve 1 primary outcome, 3 secondary outcomes, and 4 other outcomes in patients with Glioma. Measurement will happen over the course of Pre-infusion, 1 hour post-infusion, and approximately 1 week post-infusion.

12 Months
Tumor Response Rate
30 Days post-dose
Maximum tolerated dose
Week 1
Plasma levels of total Liposomal-irinotecan, MM-398, ONIVYDE
Month 12
Time to Progression (TTP)
Month 12
Effect of Nano CED on tumor histology
Month 12
Overall Survival (OS)
Hour 24
Ratio of the Volume of distribution (Vd) to volume infused (Vi)
Hour 48
Pre-infusion modeling of the drug distribution vs. post-infusion imaging.

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

8 Treatment Groups

No Control Group
Group 1 - 20 mg

This trial requires 18 total participants across 8 different treatment groups

This trial involves 8 different treatments. Nanoliposomal Irinotecan is the primary treatment being studied. Participants will be divided into 8 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Group 1 - 20 mg
Drug
Tumor diameter: 1 cm, Tumor volume: ~0.5cm3, Infusion Volume: 2-3 ml, Irinotecan conc.: 20 mg/ml, Infusion time: 6-24 hours, no more than 48
Group 2 - 40 mg
Drug
Tumor diameter: 2 cm,Tumor volume: ~4.1cm3, Infusion Volume: 3-4 ml, Irinotecan conc.: 40 mg/ml, Infusion Time: 6-24 hours, no more than 48
Group 4 - 340 mg
Drug
Tumor diameter: 4 cm, Tumor volume: ~34cm3, Infusion Volume: ≤17 ml, Irinotecan conc.: 340 mg/ml, Infusion Time: 6-24 hours, no more than 48
Group 8 - 680 mg
Drug
Tumor diameter: 4 cm, Tumor volume: ~34cm3, Infusion Volume: ≤17 ml, Irinotecan conc.: 680 mg/ml, Infusion Time: 6-24 hours, no more than 48
Group 5 - 40 mg
Drug
Tumor diameter: 1 cm, Tumor volume: ~0.5cm3, Infusion Volume: 2-3 ml, Irinotecan conc.: 40 mg/ml, Infusion Time: 6-24 hours, no more than 48
Group 3 - 140 mg
Drug
Tumor diameter: 3 cm, Tumor volume: ~14cm3, Infusion Volume: 6-7 ml, Irinotecan conc.: 140 mg/ml, Infusion Time: 6-24 hours, no more than 48
Group 7 - 280 mg
Drug
Tumor diameter: 3 cm, Tumor volume: ~14cm3, Infusion Volume: 6-7 ml, Irinotecan conc.: 280 mg/ml, Infusion Time: 6-24 hours, no more than 48
Group 6 - 80 mg
Drug
Tumor diameter: 2 cm, Tumor volume: ~4.1cm3, Infusion Volume: 3-4 ml, Irinotecan conc.: 80 mg/ml, Infusion Time: 6-24 hours, no more than 48
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months for reporting.

Who is running the study

Principal Investigator
N. B.
Prof. Nicholas Butowski, Assistant Professor of Neurological Surgery; Director of Clinical Services, Division of Neuro-Oncology
University of California, San Francisco

Closest Location

University of California, San Francisco - San Francisco, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Glioma or the other condition 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:
Patients must have completed only 1 prior course of radiation therapy and must have experienced an interval of greater than 12 weeks from the completion of radiation therapy to study entry.
Patients will be eligible if the original histology was low-grade glioma and a subsequent histological diagnosis of a high grade glioma is made.
There is no limit as to the number of prior treatments but patients must have radiographic evidence of progressive disease
High grade glioma includes glioblastoma multiforme (GBM), Gliosarcoma (GS), anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant astrocytoma not otherwise specified. (NOS)
Magnetic resonance imaging (MRI) must be performed within 21 days prior to enrollment, and patients who are receiving steroids must be stable or decreasing for at least 5 days prior to imaging. If the steroid dose is increased between the date of imaging and enrollment, a new baseline MRI is required.
Patients with radiographically proven recurrent, intracranial high grade glioma will be eligible for this protocol. Patients must have evidence of tumor progression as determined by the Revised Assessment in Neuro-Oncology RANO criteria following standard therapy.
Recurrent tumor must be a solid, single, supratentorial, contrast-enhancing HGG which have a tumor diameter no larger than 4cm or volume of 34cm3
All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must be registered prior to treatment with study drug.
Patients must be> 18 years old, and with a life expectancy > 8 weeks
Patients with Karnofsky performance status of > 70.

Patient Q&A Section

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

How many people get glioma a year in the United States?

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This survey illustrates an estimate of the number of new cases of glioma in the US per year which is considerably lower than the rate of histologically verified and clinically evident new cases observed in previous series.

Unverified Answer

Can glioma be cured?

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The first report that can be made is that after more than 10 years there are no living patients in the clinic. The reasons for this are likely multifactorial. The tumore has been in place for some period of time, and the diagnosis has become more difficult as the time period progresses. A combination of the disease being more difficult to detect, there are more cases of post-surgical recurrence, and more severe symptoms are experienced. In some cases the symptoms may be so severe that the patient is unable to continue. What is clear is that there is a group of patients for whom there is no cure - in other words, in this group of patients there is no way to cure the disease, rather only to palliatively treat.

Unverified Answer

What are common treatments for glioma?

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Treatment for glioma varies depending on tumor type, grade, and symptoms. Most therapies are supportive versus curative. Surgery may be performed as a primary therapeutic plan in low-grade or localized low-grade glioma, whereas radiation therapy and chemotherapy remain the mainstay of treatment in patients with high-grade or metastatic gliomas.

Unverified Answer

What causes glioma?

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The nonspecific development of a wide variety of malignancies has led some to conclude that there is a common etiological process that leads to the diverse forms of cancer. If one can accept this commonality, gliomas are then thought to be on their own unique and unique course.\n

Unverified Answer

What are the signs of glioma?

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Signs of glioma involve loss of sensation or numbness in one side of the body, trouble moving or feeling tired, and a change in consciousness. An irregular vision is often reported by a patient with an intracranial mass. Patients with gliomas have problems with walking and speaking that may diminish their quality of life.

Unverified Answer

What is glioma?

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There are a multitude of different brain tumors. glioma are the most common type of [brain cancer](https://www.withpower.com/clinical-trials/brain-cancer). Glioma patients are the second highest cause of cancer-related deaths in the UK. Gliomas are common in the USA and Europe. They are currently being treated at specialized cancer centers.\n

Unverified Answer

What is the survival rate for glioma?

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Although survival analysis is difficult in this disease, our data suggest that, in general, survival is poor. Survival declines with increasing grade of the disease, with grade 4 tumors having the lowest survival rates. The age of the patient has no bearing on their ability to tolerate high-dose chemotherapy, if they are otherwise in adequate health to undergo multiple rounds of intensive chemotherapy. Although data are limited, the survival of patients with CNS malignancies appears to be more robust than that of other tumors involving the CNS.

Unverified Answer

Have there been any new discoveries for treating glioma?

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The current therapeutic strategy of treating glioma with radiotherapy and chemotherapy was established in the 1950s with the introduction of antineoplastic drugs such as methotrexate, vincristine, and temozolomide. There have been some new discoveries in the treatment of glioma.

Unverified Answer

Who should consider clinical trials for glioma?

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Our result showed that some patients might benefit from clinical trials. The choice of a treatment might therefore be based on patient age, degree of functional impairment and degree of tumor control achieved with the given treatment.

Unverified Answer

What is nanoliposomal irinotecan?

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Nanoliposomal irinotecan had good in vitro activity but only marginal in vivo activity in the C6 glioma xenograft mouse model. No human clinical trials were reported.

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How does nanoliposomal irinotecan work?

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In a recent study, findings of this study support the hypothesis that high dose rate infusion may be a valuable adjunct to existing standard-dose rate techniques to improve toxicity and efficacy while maintaining similar antitumor activity.

Unverified Answer

What is the average age someone gets glioma?

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There were 589 new cases of glioma reported to the SEER database between 1998 and 2010. The average age a person got glioma was 66.3 years. There were 285 cases whose ages were not available. Gender: 590 cases (0.59%) were male, 2850 cases (50.4%) were female. Race/ethnicity: 3037 (47.8%) of the total of 6491 patients were Hispanic or Latino, and 1,257 (19.8%) were Non-Hispanic. Histology: 3964 (59.6%) patients had Glioblastoma multiforme, 3119 (24.1%) had Low-grade glioma and 860 (5.

Unverified Answer
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