Phase 1 Trial of Engineered HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors

Who is this study for? Children with recurrent or refractory cerebellar brain tumors
What treatments are being studied? G207
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study is a clinical trial to determine the safety of inoculating G207 (an experimental virus therapy) into a recurrent or refractory cerebellar brain tumor. The safety of combining G207 with a single low dose of radiation, designed to enhance virus replication, tumor cell killing, and an anti-tumor immune response, will also be tested. Funding Source- FDA OOPD

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 21
Healthy Volunteers: f
View:

• Age ≥ 36 months and \< 22 years

• Pathologically proven malignant cerebellar brain tumor (including medulloblastoma, glioblastoma multiforme, giant cell glioblastoma, anaplastic astrocytoma, primitive neuroectodermal tumor, ependymoma, atypical teratoid/rhabdoid tumor, germ cell tumor, or other high-grade malignant tumor) which is progressive or recurrent despite standard care including surgery, radiotherapy, and/or chemotherapy. A pathologically proven secondary malignant cerebellar tumor without curative treatment options is eligible.

• Lesion must be ≥ 1.0 cm ≤ 3.0 cm in diameter and surgically accessible as determined by MRI. Larger tumors may be surgically debulked and treated if ≤ 3.0 cm after debulking

• Patients must have fully recovered from acute treatment related toxicities of all prior chemotherapy, immunotherapy or radiotherapy prior to entering this study.

• Myelosuppressive chemotherapy: patients must have received their last dose at least 3 weeks prior (or at least 6 weeks if nitrosurea)

• Investigational/Biologic agents: patients must have recovered from any acute toxicities potentially related to the agent and received last dose ≥ 7 days prior to entering this study (this period must be extended beyond the time during which adverse events are known to occur for agents with known adverse events ≥ 7 days). For viral therapy, patients must have received viral therapy ≥ 3 months prior to study entry and have recovered from all acute toxicities potentially related to the agent.

• Monoclonal antibodies: The patient must have received last dose ≥ 21 days prior.

• Radiation: Patients must have received their last fraction of craniospinal radiation (\>24 Gy) or total body irradiation ≥ 3 months prior to study entry. Patients must have received focal radiation to symptomatic metastatic sites or local palliative radiation ≥ 28 days prior to study entry.

• Autologous bone marrow transplant: Patients must be ≥ 3 months since transplant prior to study entry.

• Normal hematological, renal and liver function (absolute neutrophil count \> 1000/mm3, platelets \> 100,000/mm3, prothrombin time (PT) or partial thromboplastin time (PTT) \< 1.3 x control, creatinine within normal institutional limits OR creatinine clearance \>60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal, total bilirubin \< 1.5 mg/dl, transaminases \< 3 times above the upper limits of the institutional norm)

• Patients \< 16 years, Modified Lansky performance score ≥ 60; patients ≥ 16 years, Karnofsky performance score ≥ 60

• Patient life expectancy must be at least 8 weeks

• Written informed consent in accordance with institutional and FDA guidelines must be obtained from patient or legal guardian

Locations
United States
Alabama
Children's of Alabama
ACTIVE_NOT_RECRUITING
Birmingham
Missouri
St. Louis Children's Hospital
ACTIVE_NOT_RECRUITING
St Louis
Texas
MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Kara Kachurak, CRNP
kgkachurak@mdanderson.org
832-750-5661l
Backup
Gregory K Friedman, MD
gkfriedman@mdanderson.org
Time Frame
Start Date: 2019-09-12
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 24
Treatments
Experimental: HSV G207
Single dose of HSV-1 (G207) infused through catheters into region(s) of tumor. If G207 is safe in the first cohort of patients, subsequent patients will receive a single dose of G207 infused through catheters into region(s) of tumor followed by a 5 Gy dose of radiation to the tumor given with 24 hours of virus inoculation.
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: Treovir, Inc, Cannonball Kids' Cancer Foundation

This content was sourced from clinicaltrials.gov

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