Evaluation of FDOPA-PET/MRI in Pediatric Patients With CNS Tumors

NCT01999270 | Completed Phase 1

• 1 other identifier: 201303069
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if FDOPA-PET/MRI imaging can predict response to treatment of bevacizumab.

Conditions

Astrocytoma, Oligoastrocytoma, Mixed; Ganglioneuroma; Glioma; Ganglioglioma; Glioblastoma Multiforme Glioma

Outcome Measures

Primary Outcomes (1)

• FDOPA-PET/MRI imaging

  The imaging is evaluated: (a) the uptake of PET tracer FDOPA measured by average and maximal standardized uptake values (SUVs) as well as tumor to normal brain ratios; and (b) tumor volumes defined by MRI signal abnormality.

  1 year

Study Arms (1)

Irinotecan, Bevacizumab and FDOPA-PET/MRI imaging

EXPERIMENTAL

Irinotecan can be removed from the treatment plan at the discretion of the healthcare provider.

Drug: Irinotecan; Drug: Bevacizumab; Device: FDOPA-PET/MRI imaging

Interventions

Irinotecan DRUG

Irinotecan IV over 90 minutes on Days 1, 15, and 29 of each cycle (except Cycle 1, when it will be started on Day 29) Note: Irinotecan can be removed from the treatment plan at the discretion of the healthcare provider.

Also known as: Camptosar®, CPT-11

Irinotecan, Bevacizumab and FDOPA-PET/MRI imaging

Bevacizumab DRUG

Bevacizumab will be given intravenously AFTER the irinotecan infusion is complete on Days 1, 15, and 29 of each cycle. The first dose will be given over 90 minutes, but doses after that may be given over 30-60 minutes.

Also known as: Avastin®

Irinotecan, Bevacizumab and FDOPA-PET/MRI imaging

FDOPA-PET/MRI imaging DEVICE

FDOPA-PET/MRI imaging Baseline (before beginning Cycle 1 treatment) Cycle 1, Day 29 (before receiving your treatment with bevacizumab) and end of treatment or time of relapse

Irinotecan, Bevacizumab and FDOPA-PET/MRI imaging

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient must have histological verification of one of the eligible diagnosis listed below. Biopsy is required at time of diagnosis, with the exception of optic pathway tumors. Patients with spinal cord disease are eligible if they have a lesion \>1 cm in 2 dimensions. The following histologies are eligible:
• Astrocytoma variants: fibrillary, protoplasmic, mixed
• Pilocytic astrocytoma, including pilomyxoid variants
• Pleomorphic xanthoastrocytoma
• Infantile desmoplastic astrocytoma
• Ganglioneuroma
• Oligodendroglial tumor
• Mixed glioma (including oligoastrocytoma)
• Anaplastic astrocytoma
• Anaplastic oligoastrocytoma
• Anaplastic oligodendroglioma
• Anaplastic ganglioglioma
• Glioblastoma multiforme (including giant cell and gliosarcoma types)
• Medulloblastoma
• Ependymoma

You may not qualify if:

• Patient must not have had myelosuppressive chemotherapy ≤ 3 weeks prior to entry onto this study (or 6 weeks if prior nitrosourea).
• Patient must not have had any anti-neoplastic biologic agent ≤7 days prior to entry onto this study (or at least 3 half-lives for biologic agents with a long half-life).
• Patient must not have received craniospinal radiotherapy or involved field radiotherapy to the local tumor (and/or tumor designated as "measurable" for protocol purposes) ≤ 24 weeks prior to study entry; focal radiation to areas of symptomatic metastatic disease must not be given within 14 days of study entry.
• Patient must not have received bevacizumab, or other anti-VEGF inhibitor in the last 3 months.
• Patient must not require a major surgical procedure ≤ 21 days prior to beginning therapy.
• Patient must not require an intermediate surgical procedure ≤14 days prior to beginning therapy.
• Patient must not require a minor surgical procedure (i.e., Broviac line or infusaport placement) ≤ 7 days prior to beginning therapy, and the wound must be healed prior to initiation of therapy.
• There should be no anticipation of need for major surgical procedures during the course of the study.
• Patient must not have received any growth factors ≤7 days of entry onto this study.
• Patient must not be taking NSAIDS, clopidogrel, dipyridamole, or aspirin therapy \>81 mg/day.
• Patient must not have a serious or non-healing wound, ulcer, or bone fracture.
• Patient must not require sedation for imaging purposes.
• Patient must not be receiving an investigational drug.
• Patient must not be receiving any other anti-cancer agent.
• Patient must not have an uncontrolled infection.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Astrocytoma; Ganglioneuroma; Glioma; Ganglioglioma

Interventions

Irinotecan; Bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Karen Gauvain, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 3, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 21, 2016

Record last verified: 2016-10

Locations

US (1)