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Topoisomerase I inhibitor

nanoliposomal irinotecan for Brain Tumor

Phase 1
Waitlist Available
Led By Nicholas Butowski, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The effects of nano liposomal irinotecan on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception: hormonal or barrier method of birth control; abstinence, etc. prior to study entry, for the duration of study participation, and for 6 months post drug administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights

Study Summary

This trial is testing a new way to give a higher dose of a cancer drug called irinotecan to people with a certain type of brain tumor.

Eligible Conditions
  • Brain Tumor

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
The effect of the study drug on an unborn baby is unknown, so women who can become pregnant and men must use effective birth control during the study and for 6 months after taking the drug. If a woman becomes pregnant or thinks she might be pregnant during the study, she should tell her doctor right away.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose
Secondary outcome measures
Objective Tumor Response Rate
Overall Survival (OS)
Overall Survival at 12 months
+2 more
Other outcome measures
Change in Tumor Histology
Mean plasma levels of total Liposomal-irinotecan (MM-398, ONIVYDE)
Pre-infusion modeling of the drug distribution vs. post-infusion imaging.
+1 more

Side effects data

From 2016 Phase 2 trial • 175 Patients • NCT01055314
36%
Febrile neutropenia
31%
Death NOS
30%
Diarrhea
22%
Pain
21%
Hyperglycemia
16%
Anorexia
16%
Infections and infestations - Other, specify
16%
Alanine aminotransferase increased
14%
Hypokalemia
13%
Nausea
11%
Hyponatremia
10%
Weight loss
9%
Aspartate aminotransferase increased
9%
Anemia
9%
Mucositis oral
9%
Vomiting
9%
Constipation
9%
Dehydration
9%
Hypophosphatemia
8%
Platelet count decreased
8%
Sepsis
7%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
7%
Catheter related infection
7%
Colitis
7%
Abdominal pain
6%
Hypotension
6%
White blood cell decreased
6%
GGT increased
6%
Hypocalcemia
6%
Urinary retention
6%
Hypoalbuminemia
6%
Fever
5%
Anxiety
5%
Typhlitis
5%
Neutrophil count decreased
5%
Urinary tract infection
4%
Peripheral motor neuropathy
4%
Enterocolitis
4%
Lipase increased
4%
Pleural effusion
4%
Serum amylase increased
4%
Skin infection
4%
Epistaxis
4%
Urinary tract obstruction
3%
Lymphocyte count decreased
3%
Wound infection
3%
Blood bilirubin increased
3%
Syncope
3%
Dermatitis radiation
3%
Hypertension
3%
Sinus tachycardia
3%
Edema limbs
3%
Bone pain
3%
Dyspnea
3%
Hematuria
3%
Hypercalcemia
2%
Thromboembolic event
2%
Upper gastrointestinal hemorrhage
2%
Vulval infection
2%
Depressed level of consciousness
2%
Stridor
2%
Allergic reaction
2%
Back pain
2%
Lung infection
2%
Urticaria
2%
Acute kidney injury
2%
Muscle weakness lower limb
2%
Musculoskeletal and connective tissue disorder - Other, specify
2%
Pain in extremity
2%
Peripheral sensory neuropathy
2%
Proctitis
2%
Skin ulceration
2%
Apnea
2%
Stoma site infection
2%
Tumor pain
2%
Left ventricular systolic dysfunction
2%
Pancreatitis
2%
Portal hypertension
2%
Rectal hemorrhage
2%
Creatinine increased
2%
Enterocolitis infectious
2%
Hyperkalemia
2%
Investigations - Other, specify
2%
Abdominal distension
1%
Esophageal pain
1%
Gastrointestinal disorders - Other, specify
1%
Heart failure
1%
Hepatobiliary disorders - Other, specify
1%
Penile pain
1%
Vascular disorders - Other, specify
1%
Ascites
1%
Bone marrow hypocellular
1%
Anaphylaxis
1%
Delirium
1%
Sore throat
1%
Vasovagal reaction
1%
Anal hemorrhage
1%
Soft tissue infection
1%
Tracheitis
1%
Anal mucositis
1%
Seizure
1%
Menorrhagia
1%
Fracture
1%
Hydrocephalus
1%
Device related infection
1%
Tooth infection
1%
Gastric ulcer
1%
Sinusitis
1%
Skin and subcutaneous tissue disorders - Other, specify
1%
Pharyngitis
1%
Pyramidal tract syndrome
1%
Anal ulcer
1%
Depression
1%
Ejection fraction decreased
1%
Rash maculo-papular
1%
Pruritus
1%
Myositis
1%
Nail infection
1%
Pain of skin
1%
Pleuritic pain
1%
Pneumonitis
1%
Pneumothorax
1%
Postoperative hemorrhage
1%
Renal and urinary disorders - Other, specify
1%
Respiratory, thoracic and mediastinal disorders - Other, specify
1%
Salivary duct inflammation
1%
Small intestine infection
1%
Alkaline phosphatase increased
1%
Appendicitis
1%
Spinal fracture
1%
Disseminated intravascular coagulation
1%
Ear and labyrinth disorders - Other, specify
1%
Endocrine disorders - Other, specify
1%
Esophageal stenosis
1%
Esophagitis
1%
Gastric hemorrhage
1%
Gum infection
1%
Tumor lysis syndrome
1%
Upper respiratory infection
1%
Hypertriglyceridemia
1%
Hypoxia
1%
Ileus
1%
INR increased
1%
Laryngeal edema
1%
Multi-organ failure
1%
Myelodysplastic syndrome
1%
Oral hemorrhage
1%
Oral pain
1%
Pulmonary edema
1%
Rectal fistula
1%
Rectal pain
1%
Respiratory failure
1%
Bladder spasm
1%
Chest wall pain
1%
Confusion
1%
Congenital, familial and genetic disorders - Other, specify
1%
CPK increased
1%
Dizziness
1%
Encephalopathy
1%
Eye disorders - Other, specify
1%
Generalized muscle weakness
1%
Hoarseness
1%
Hypernatremia
1%
Hypoglycemia
1%
Hypomagnesemia
1%
Insomnia
1%
Irregular menstruation
1%
Irritability
1%
Joint range of motion decreased cervical spine
1%
Kyphosis
1%
Lethargy
1%
Headache
1%
Laryngeal mucositis
1%
Pelvic pain
1%
Esophageal infection
1%
Abdominal infection
1%
Acidosis
1%
Anal fistula
1%
Fall
1%
Fatigue
1%
Gait disturbance
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)
Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)

Trial Design

8Treatment groups
Experimental Treatment
Group I: Group 8 - 680 mgExperimental Treatment1 Intervention
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 II: Group 7 - 280 mgExperimental Treatment1 Intervention
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 III: Group 6 - 80 mgExperimental Treatment1 Intervention
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
Group IV: Group 5 - 40 mgExperimental Treatment1 Intervention
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 V: Group 4 - 340 mgExperimental Treatment1 Intervention
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 VI: Group 3 - 140 mgExperimental Treatment1 Intervention
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 VII: Group 2 - 40 mgExperimental Treatment1 Intervention
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 VIII: Group 1 - 20 mgExperimental Treatment1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
FDA approved

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,498 Previous Clinical Trials
11,936,330 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,646 Previous Clinical Trials
40,931,009 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,690 Previous Clinical Trials
6,950,990 Total Patients Enrolled

Frequently Asked Questions

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

How many participants are in this experiment?

"At the present time, this study is not open for further recruitment. It was first posted on October 23rd 2014 and most recently updated on November 1st 2022. Alternatively, there are 357 trials with glioma patients actively recruiting participants and 263 studies recruiting nanoliposomal irinotecan volunteers."

Answered by AI

Has nanoliposomal irinotecan been researched in previous trials?

"Currently, there are 263 active studies concerning nanoliposomal irinotecan with 53 of them being in their final stage. Most trials for this particular drug occur in Adelaide, South Australia; however, a total of 8629 institutions globally run experiments involving the same medication."

Answered by AI

How does nanoliposomal irinotecan impact a person's safety?

"The safety of nanoliposomal irinotecan has been determined to be a 1, as this is a Phase 1 trial with limited evidence supporting both its efficacy and security."

Answered by AI

Are individuals still able to join this research endeavor?

"This medical trial, according to the clinicaltrials.gov database, is not currently recruiting participants—even though it was first posted on October 23rd 2014 and updated lastly on November 1st 2022. However, there are 620 other active trials with open recruitment at this time."

Answered by AI

What pathological conditions often require nanoliposomal irinotecan as a form of treatment?

"Nanoliposomal irinotecan is frequently utilized to combat malignant neoplasms of the pancreas. It may also be employed for treating metastatic tumors, gastric cancer, and rhabdomyosarcoma."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Convection-Enhanced, Image-Assisted Delivery of Liposomal-Irinotecan In Recurrent High Grade Glioma
Nicholas Butowski 2014. "Study of Convection-Enhanced, Image-Assisted Delivery of Liposomal-Irinotecan In Recurrent High Grade Glioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02022644.
~2 spots leftby Apr 2025
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