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Topoisomerase I inhibitor

Newly Diagnosed DIPG for Diffuse Intrinsic Pontine Glioma

Phase 1
Waitlist Available
Research Sponsored by Sabine Mueller, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

This trial is testing a new way to give a cancer drug to kids with a rare brain tumor. They'll use brain imaging to see if it works.

Eligible Conditions
  • Diffuse Intrinsic Pontine Glioma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants Experiencing Treatment-Related Adverse Events (AE)
Secondary outcome measures
Overall Survival (OS) at 12 months (OS12)
Other outcome measures
Distribution of Gadolinium

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%
Mucositis oral
9%
Anemia
9%
Aspartate aminotransferase increased
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%
Typhlitis
5%
Anxiety
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%
Blood bilirubin increased
3%
Lymphocyte count decreased
3%
Syncope
3%
Wound infection
3%
Dermatitis radiation
3%
Hypertension
3%
Sinus tachycardia
3%
Edema limbs
3%
Bone pain
3%
Dyspnea
3%
Hematuria
3%
Hypercalcemia
2%
Vulval infection
2%
Upper gastrointestinal hemorrhage
2%
Depressed level of consciousness
2%
Thromboembolic event
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%
Seizure
1%
Soft tissue infection
1%
Bone marrow hypocellular
1%
Gastrointestinal disorders - Other, specify
1%
Heart failure
1%
Vasovagal reaction
1%
Hepatobiliary disorders - Other, specify
1%
Penile pain
1%
Delirium
1%
Vascular disorders - Other, specify
1%
Ascites
1%
Esophageal pain
1%
Anal mucositis
1%
Menorrhagia
1%
Anal hemorrhage
1%
Sore throat
1%
Anaphylaxis
1%
Tracheitis
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

1Treatment groups
Experimental Treatment
Group I: Newly Diagnosed DIPGExperimental Treatment1 Intervention
Convection Enhanced Delivery (CED) of Nanoliposomal irinotecan (nal-IRI): Nal-IRI given directly into the tumor using a method called CED to newly diagnosed DIPG subjects after completion of radiotherapy. CED will be performed every 4-8 weeks. Drug concentration will start at 20mg/ml and escalate up to 40 mg/ml concentration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Convection Enhanced Delivery (CED) of Nanoliposomal irinotecan (nal-IRI)
2017
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

Sabine Mueller, MD, PhDLead Sponsor
8 Previous Clinical Trials
429 Total Patients Enrolled
3 Trials studying Diffuse Intrinsic Pontine Glioma
87 Patients Enrolled for Diffuse Intrinsic Pontine Glioma
The V Foundation for Cancer ResearchOTHER
19 Previous Clinical Trials
1,291 Total Patients Enrolled
2 Trials studying Diffuse Intrinsic Pontine Glioma
105 Patients Enrolled for Diffuse Intrinsic Pontine Glioma
Pacific Pediatric Neuro-Oncology ConsortiumOTHER
14 Previous Clinical Trials
755 Total Patients Enrolled
4 Trials studying Diffuse Intrinsic Pontine Glioma
144 Patients Enrolled for Diffuse Intrinsic Pontine Glioma
~1 spots leftby Sep 2025
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