Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02960230 : H3.3K27M Peptide Vaccine for Children With Newly Diagnosed DIPG and Other Gliomas
PhasePhase 1
AgesMin: 3 Years Max: 21 Years
Eligibility
Inclusion Criteria:

- Stratum A:

- Newly diagnosed children (3-21 years old) with DIPG who are positive for the
H3.3K27M mutation (positive testing in CLIA laboratory) that underwent standard
radiation therapy.

Stratum B:

• Newly diagnosed children (3-21 years old) with diagnosis of glioma other than DIPG who
are positive for the H3.3K27M mutation (positive testing in CLIA laboratory) including
spinal cord gliomas that underwent standard radiation therapy.

The following eligibility criteria apply to both Stratum A and B.

- The patient must test positive for HLA-A2 (human leukocyte antigen A2)(CLIA approved
laboratory)

- The patient must have evaluable disease as defined in section 7.2.1.2

- The patient must be either off steroids or be on stable dose of dexamethasone (max 0.1
mg/kg/day; maximum 4mg/day) at time of enrollment

- Patients must not have received any prior chemotherapy, immunotherapy or bone marrow
transplant for the treatment of their tumor. Prior use of temozolomide during
radiation at the standard pediatric dosing or dexamethasone is allowed.

- Patients must have undergone radiation therapy and surgery as part of their standard
of care.

o Radiation therapy must have started within 28 days of diagnosis by imaging or
surgery, whichever is later.

- Karnofsky ? 50 for patients ? 16 years of age, and Lansky ? 50 for patients < 16 years
of age (See Appendix A). 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.

- The patient must have adequate organ function defined as:

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).

Adequate Renal Function Defined as:

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) ? 70mL/min/1.73
m2 or

- A serum creatinine based on age/gender as follows:

Age Maximum Serum Creatinine (mg/dL) Male Female

1. - 2 years 0.6 0.6

2. 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 The threshold
creatinine values in this table were derived from the Schwartz formula for estimating GFR
utilizing child length and stature data published by the CDC.

Adequate Liver Function Defined as:

- Bilirubin (sum of conjugated + unconjugated) ? 1.5 x upper limit of normal (ULN) for
age and

- SGPT (ALT) ? 110 U/L and

- Serum albumin ? 2 g/dL.

Adequate Neurologic Function Defined as:

- Patients with seizure disorder may be enrolled if seizure disorder is well controlled.

- The effects of the H3.3K27M vaccine on the developing human fetus are unknown. For
this reason, females of child-bearing potential and men must agree to use adequate
contraception. Adequate methods include: hormonal or barrier method of birth control;
or abstinence prior to study entry and for the duration of study participation. 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. Men
treated or enrolled on this protocol must also agree to use adequate contraception
prior to the study and for the duration of study participation.

- Ability to understand a written informed consent document, and the willingness to sign
it. Assent will be obtained when appropriate based on the subjects age.

Exclusion Criteria:

- • Investigational Drugs: Patients who are currently receiving another investigational
drug are not eligible.

- Anti-cancer Agents: Patients who are currently receiving other anti-cancer agents
are not eligible.

- Patients with a history of auto-immune disorder requiring systemic cytotoxic or
immunosuppressive therapy are not eligible.
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02960230      |      Link to official Clinicaltrials.gov listing
Locations
San Diego, California
Facility: Rady Children's Hospital-San Diego
Investigator:
Contact: Jennifer Elster, MD Phone: 858-576-1600
Click HERE to send email to this center

San Francisco, California
Facility: UCSF Helen Diller Family Comprehensive Cancer Center
Investigator:
Contact: Sabine Mueller, MD Phone: 415-476-3831
Click HERE to send email to this center

Washington, D.C., District of Columbia
Facility: Children's National Medical Center
Investigator:
Contact: Lindsay Kilburn, MD Phone: 202-476-3854
Click HERE to send email to this center

Chicago, Illinois
Facility: Ann & Robert H. Lurie Children's Hospital of Chicago
Investigator:
Contact: Stewart Goldman, MD Phone: 312-227-4873
Email not avaialable

Boston, Massachusetts
Facility: Dana-Farber Cancer Institute
Investigator:
Contact: Susan Chi, MD Phone: 617-632-4386
Click HERE to send email to this center

Saint Louis, Missouri
Facility: St. Louis Children's Hospital
Investigator:
Contact: Karen Gauvain, MD Phone: 314-454-2002
Click HERE to send email to this center

Portland, Oregon
Facility: Oregon Health & Science University
Investigator:
Contact: Kellie Nazemi, MD Phone: 503-494-1543
Click HERE to send email to this center

Philadelphia, Pennsylvania
Facility: Children's Hospital of Philadelphia
Investigator:
Contact: Jane Minturn, MD, PhD Phone: 267-426-5026
Click HERE to send email to this center

Seattle, Washington
Facility: Seattle Children's Hospital
Investigator:
Contact: Sarah Leary, MD Phone: 206-987-2106
Click HERE to send email to this center




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