H3.3K27M Peptide Vaccine for Children With Newly Diagnosed DIPG and Other Gliomas



Status:Recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:3 - 21
Updated:7/11/2018
Start Date:November 2016
End Date:November 2020
Contact:Sabine Mueller, MD, PhD, MAS
Email:cancertrials@ucsf.edu
Phone:877-827-3222

Use our guide to learn which trials are right for you!

H3.3K27M Specific Peptide Vaccine Combined With Poly-ICLC for the Treatment of Newly Diagnosed HLA-A2+ H3.3K27M Positive Diffuse Intrinsic Pontine Glioma (DIPG) as Well as Other Newly Diagnosed HLA-A2+ H3.3K27M Positive Gliomas

This is a two cohort Phase I study within the Pacific Pediatric Neuro-Oncology Consortium
(PNOC).

This study will assess the safety of repeated administration of the H3.3K27M specific vaccine
in HLA-A2+ children and young adults with H3.3K27M DIPGs and other gliomas.

Subjects who are eligible will receive a specific peptide vaccine, along with a helper drug
called poly-ICLC, every 3 weeks for the first 6 months of treatment. Subjects will be
monitored routinely by laboratory assessments, physical evaluation, vital signs, and MRI.
Subjects who tolerate therapy well and have stable or improved disease after 6 months of
treatment can continue to receive treatment, now every 6 weeks, for a total of 96 weeks of
treatment.

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 (tested by a CLIA approved laboratory; only
the HLA A*02:01 subtype is eligible) The patient must be either off systemic 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 maximum of the standard pediatric dosing (defined as 90 mg/m^2/dose
continuously during radiation therapy for 42 days) or dexamethasone is allowed.

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

- Stratum A: Radiation therapy must have started within 4 weeks of diagnosis by
imaging or surgery, whichever is later.

- Stratum B: For subjects undergoing surgery for more extensive resection,
radiation therapy should be started within 4-6 weeks from surgery.

- H3.3K27 mutation must have been confirmed in the tumor tissue in a CLIA approved
laboratory.

- 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.

- Prior treatment with another investigational drug.

- Anti-cancer Agents

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

- Prior treatment with other anti-cancer agents.

- Patients with a known disorder that affects their immune system, such as HIV, or an
autoimmune disorder requiring systemic cytotoxic or immunosuppressive therapy are not
eligible. Note: Patients that are currently using inhaled, intranasal, ocular, topical
or other non-oral or non-IV steroids are not necessarily excluded from the study but
need to be discussed with the study chair

- 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 prior to the start of therapy (as clinically indicated).
We found this trial at
14
sites
3020 Childrens way
San Diego, California 92123
(858) 576-1700
Phone: 858-576-1600
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
?
mi
from
San Diego, CA
Click here to add this to my saved trials
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Phone: 614-722-4087
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
?
mi
from
Columbus, OH
Click here to add this to my saved trials
262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
Phone: 901-595-2615
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
?
mi
from
Memphis, TN
Click here to add this to my saved trials
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Phone: 267-426-5026
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-494-1543
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
?
mi
from
Portland, OR
Click here to add this to my saved trials
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Phone: 801-662-4700
University of Utah Research is a major component in the life of the U benefiting...
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
1600 Divisadero Street
San Francisco, California 94115
888.689.8273
Phone: 415-476-3831
UCSF Helen Diller Family Comprehensive Cancer Center UCSF’s long tradition of excellence in cancer research...
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-4386
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials
225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Phone: 312-227-4873
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
?
mi
from
Chicago, IL
Click here to add this to my saved trials
6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Phone: 832-824-4681
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Minneapolis, Minnesota 55404
Phone: 612-626-2778
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Saint Louis, Missouri 63110
Phone: 314-454-2002
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Phone: 206-987-2106
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Phone: 202-476-3854
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
?
mi
from
Washington,
Click here to add this to my saved trials