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CED With Irinotecan Liposome Injection Using Real Time Imaging in Children With DIPG

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by University of California, San Francisco
Sponsor:
Collaborators:
The V Foundation for Cancer Research
Pacific Pediatric Neuro-Oncology Consortium
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT03086616
First received: March 16, 2017
Last updated: July 11, 2017
Last verified: July 2017
  Purpose
This is a Phase I and Early Efficacy Study of Convection Enhanced Delivery (CED) of irinotecan liposome injection (nal-IRI) Using Real Time Imaging with Gadolinium in Children with Diffuse Intrinsic Pontine Glioma who have completed focal radiotherapy

Condition Intervention Phase
Diffuse Intrinsic Pontine Glioma Drug: Convection Enhanced Delivery (CED) of Nanoliposomal irinotecan (nal-IRI) Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I and Early Efficacy Study of Convection Enhanced Delivery of Irinotecan Liposome Injection Using Real Time Imaging With Gadolinium in Children With Diffuse Intrinsic Pontine Glioma

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Number of Participants with Adverse Events related to treatment [ Time Frame: 12 months ]
    Safety of repeated CED of nal-IRI following standard of care focal radiotherapy will be assessed by monitoring for adverse events, scheduled laboratory assessments, vital sign measurements, and physical examinations for subjects who receive the vaccination. The severity of toxicities will be graded according to the NCI CTCAE v4.0. Adverse events and clinically significant laboratory abnormalities (meeting Grade 3, 4, or 5 criteria according to CTCAE) will be summarized by maximum intensity and relationship to study drug(s). Grade 1 and 2 adverse events will be summarized if related to study therapy.


Secondary Outcome Measures:
  • Overall Survival (OS) at 12 months (OS12) [ Time Frame: 12 months ]
    Any eligible subject treated on the dose level that will be investigated within the expansion cohort will be considered evaluable for clinical efficacy. Analyses will be performed after all enrolled patients have completed 12 months, or whenever the status of all patients has been established, whichever comes first.


Other Outcome Measures:
  • Distribution of Gadolinium [ Time Frame: 12 months ]
    Assessment of observed distribution of gadolinium compared to pre-treatment modeling of the drug distribution utilizing predictive imaging software.


Estimated Enrollment: 19
Anticipated Study Start Date: July 2017
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Newly Diagnosed DIPG
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 4-6 weeks. Drug concentration will start at 20mg/ml and escalate up to 40 mg/ml concentration.
Drug: Convection Enhanced Delivery (CED) of Nanoliposomal irinotecan (nal-IRI)
Nal-IRI will be given directly into the tumor using CED.
Other Name: Irinotecan Liposome Injection

Detailed Description:
This study will assess the safety and tolerability of repeated administration of nal-IRI co-infused with gadoteridol given by intratumoral CED in children with newly diagnosed DIPG.
  Eligibility

Ages Eligible for Study:   3 Years to 39 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with newly diagnosed DIPG who have completed focal radiotherapy are eligible. Patients with disseminated disease are not eligible, and MRI of the spine must be performed if disseminated disease is suspected by the treating physician.
  • Treatment must begin at a minimum of 28 days after but no later than 42 days of the date of the completion of radiotherapy.
  • Prior Chemotherapy: No prior experimental chemotherapy is allowed. If a subject received chemotherapy during radiation, the subject needs to be discussed with the study chair(s). The use of temolzolomide is allowed at standard pediatric dosing during radiation therapy. All other therapies need to be discussed with the study chair.
  • Prior Radiation: Patients must have received prior treatment with focal radiotherapy as part of initial treatment for DIPG and had their last dose at least 28 days prior to and no later than 42 days from the first CED treatment with liposomal-irinotecan.
  • Age ≥ 3 and < 39 years of age.
  • Karnofsky ≥ 50 for patients > 16 years of age and Lansky ≥ 50 for patients 16 years of age and younger. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
  • Life expectancy of greater than 12 weeks measured from the date of completion of radiotherapy.
  • Corticosteroids: Patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to registration.
  • Organ Function Requirements

    • Adequate Bone Marrow Function Defined as:Peripheral absolute neutrophil count (ANC) ≥1000/mm3 and platelet count ≥ 100,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) and normal coagulation defined as normal INR or per institutional guidelines.
    • Adequate Renal Function Defined as:

      • Creatinine clearance or radioisotope GFR ≥ 70mL/min/1.73 m2 or
      • A serum creatinine based on age/gender as follows:

Age Maximum Serum Creatinine (mg/dL) Male Female 3 to < 6 years 0.8 0.8 6 to < 10 years 1 1 10 to < 13 years 1.2 1.2 13 to < 16 years 1.5 1.4

≥ 16 years 1.7 1.4

  • Adequate Liver Function Defined as: Bilirubin (sum of conjugated + unconjugated) less than or equal to 1.5 x upper limit of normal (ULN) for age and SGPT (ALT) less than or equal to 110 U/L. and Serum albumin ≥ 2 g/dL.
  • Adequate Neurologic Function Defined as: Patients with seizure disorder may be enrolled if on non-enzyme inducing anticonvulsants and well controlled.

    • The effects of irinotecan liposome injection 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) prior to study entry, for the duration of study participation and 4 months after completion of irinotecan liposome injection 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.
    • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients who have had prior experimental chemotherapy.
  • Patients who are receiving any other investigational agents.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to irinotecan, topotecan, gadolinium, or lipids.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Female patients of childbearing potential must not be pregnant or breast-feeding. Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days of registration.
  • Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy.
  • Patients with MRI or clinical evidence of uncontrolled tumor mass effect are excluded; the assessment of mass effect should be made by the study chair and study neurosurgeon prior to any planned CED treatment.
  • Leptomeningeal or subarachnoid disseminated disease.
  • Patients with evidence of hemorrhage (besides what is expected if a patient underwent a biopsy). These subjects should be discussed with the study chair.
  • Patients with evidence of cystic changes greater than 1 cm in diameter will be excluded. These subjects should be discussed with the study chair.
  • Patients must not be on enzyme-inducing anticonvulsants or other drugs that might interact with the cytochrome P450 enzyme system. If previously on an EIAED, patient must be off for at least 10 days prior to CED infusion.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03086616

Contacts
Contact: Sabine Mueller, MD, PhD, MAS (415) 476-3831 sabine.mueller@ucsf.edu
Contact: Jenna Weight, BA (415) 502-1600 jenna.weight@ucsf.edu

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94158
Contact: Sabine Mueller, MD    415-476-3831    sabine.mueller@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
The V Foundation for Cancer Research
Pacific Pediatric Neuro-Oncology Consortium
Investigators
Study Chair: Sabine Mueller, MD, PhD, MAS University of California, San Francisco
  More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03086616     History of Changes
Other Study ID Numbers: PNOC 009
160816 ( Other Identifier: University of California, San Francisco )
Study First Received: March 16, 2017
Last Updated: July 11, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:
DIPG
CED
glioma

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Irinotecan
Camptothecin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2017