Description:
The purpose of this study is to establish the safety and tolerability of simultaneous
infusions of 5-Azacytidine and trastuzumab into the fourth ventricle of the brain or
resection cavity in patients with recurrent posterior fossa ependymoma and to assess the
antitumor activity of simultaneous infusions of 5-Azacytidine and trastuzumab into the fourth
ventricle of the brain or resection cavity in patients based upon imaging studies and lumbar
cerebrospinal fluid (CSF) cytology.
Title
- Brief Title: Combination Intraventricular Chemotherapy Pilot Study: 5-Azacytidine (5-AZA) and Trastuzumab Infusions Into the Fourth Ventricle or Resection Cavity in Children and Adults With Recurrent or Residual Posterior Fossa Ependymoma
- Official Title: Combination Intraventricular Chemotherapy Pilot Study: 5-Azacytidine (5-AZA) and Trastuzumab Infusions Into the Fourth Ventricle or Resection Cavity in Children and Adults With Recurrent or Residual Posterior Fossa Ependymoma
Clinical Trial IDs
- ORG STUDY ID:
HSC-MS-21-0231
- NCT ID:
NCT04958486
Conditions
Interventions
Drug | Synonyms | Arms |
---|
5-Azacytidine and trastuzumab infusion | | Treatment |
Purpose
The purpose of this study is to establish the safety and tolerability of simultaneous
infusions of 5-Azacytidine and trastuzumab into the fourth ventricle of the brain or
resection cavity in patients with recurrent posterior fossa ependymoma and to assess the
antitumor activity of simultaneous infusions of 5-Azacytidine and trastuzumab into the fourth
ventricle of the brain or resection cavity in patients based upon imaging studies and lumbar
cerebrospinal fluid (CSF) cytology.
Trial Arms
Name | Type | Description | Interventions |
---|
Treatment | Experimental | | - 5-Azacytidine and trastuzumab infusion
|
Eligibility Criteria
Inclusion Criteria:
- Patients with histologically verified ependymoma, with recurrence or progression
anywhere in the brain and/or spine. Patients are also eligible if they have refractory
disease, which will be defined as residual tumor which has not been completely cleared
despite prior treatments. To be eligible, patients' disease must have originated in
the posterior fossa of the brain
- Patient must have either measurable or evaluable tumor as assessed by MRI of the brain
and total spine
- An implanted catheter in the fourth ventricle or posterior fossa tumor cavity attached
to a ventricular access device or agreement to have one placed.
- A minimum of 4 weeks between any prior radiation treatments or bevacizumab infusions
and first infusion of 5-azacytidine or trastuzumab infusions. A minimum of 2 weeks
between last dose of any other systemic chemotherapy and first infusion of
5-azacytidine or Trastuzumab into fourth ventricle
- Life expectancy of at least 12 weeks in the opinion of the principal investigator
- Lansky score of 50 or greater if ≤16 years of age or Karnofsky score of 50 or greater
if > 16 years of age
- Existing neurological deficits must have been stable for a minimum of 1 week prior to
study enrollment
- Patients must have recovered from the acute toxic effects of all prior anticancer
chemotherapy
- Adequate bone marrow function defined by peripheral absolute neutrophil count (ANC) ≥
500/µL, platelet count ≥ 50,000/µL (transfusion independent), and hemoglobin ≥ 9.0
gm/dL (may receive red blood cell (RBC) transfusions)
- Patient or patient's legal representative, parent(s), or guardian able to provide
written informed consent.
- Patient with abnormal cardiac function (Shortening fraction less than 28% on
echocardiogram) will need cardiology clearance prior to enrollment
- Normal renal and liver function on basic metabolic panel. Any patients with abnormal
blood urea nitrogen (BUN), creatinine, alanine aminotransferase(AST) or aspartate
aminotransferase (ALT) levels will need nephrology and/or gastroenterology clearance
prior to enrollment
Exclusion Criteria:
- Enrolled in another treatment protocol
- Patients with disease that is completely resectable
- Has received another investigational or chemotherapy agent within 2 weeks or radiation
therapy within 4 weeks prior to 5-azacytidine or trastuzumab infusion into the fourth
ventricle
- Patients with any cardiac issues who are not cleared by cardiology for participation
in the study
- Evidence of untreated infection
- Pregnant or lactating women
Maximum Eligible Age: | 80 Years |
Minimum Eligible Age: | 1 Year |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of patients with new neurological deficits |
Time Frame: | 7 days after treatment |
Safety Issue: | |
Description: | A new neurological deficit will be defined as new cranial neuropathy, change in level of consciousness, motor weakness, gait change or cerebellar finding (ataxia, dysmetria, dysdiadochokinesis) that is attributed by treating physicians to infusions. New neurological deficits graded as Grade 3 or higher after infusions will be defined as serious adverse events (SAE's) |
Secondary Outcome Measures
Measure: | Change in disease progression as assessed by magnetic resonance imaging (MRI) |
Time Frame: | Baseline(before start of treatment),end of treatment (7 days after treatment) |
Safety Issue: | |
Description: | |
Measure: | Change in disease progression as assessed by lumbar CSF cytology |
Time Frame: | Baseline(before start of treatment),end of treatment (7 days after treatment) |
Safety Issue: | |
Description: | |
Details
Phase: | Early Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | The University of Texas Health Science Center, Houston |
Trial Keywords
Last Updated
August 5, 2021