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Phase II Trial of Molecularly Determined Treatment of Children and Young Adults With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas


Phase 2
3 Years
18 Years
Open (Enrolling)
Both
Diffuse Intrinsic Pontine Glioma

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Trial Information

Phase II Trial of Molecularly Determined Treatment of Children and Young Adults With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas


Inclusion Criteria:



Participants must meet the following criteria on screening examination to be eligible to
participate in the study:

1. Tumor: Newly diagnosed non-disseminated diffuse intrinsic pontine glioma based on
classic clinical AND radiographic finding.

2. No prior radiation therapy or chemotherapy.

3. Age: Patient must be 3 to < 18 years of age at the time of diagnosis.

4. Performance Score: Karnofsky Performance Scale > 12 y/o >/= 50 or Lansky
Performance Score for patients < 12y/o 50 assessed within two-weeks prior to
enrollment.

5. Participants must have normal organ and marrow function as defined below within two
week s prior to enrollment:

- Absolute neutrophil count > 1,000/mcL

- Platelets > 100,000/mcL (transfusion independent)

- Hemoglobin > 8gm/dL (can be transfused)

- Hepatic: Total bilirubin < 1.5 times the upper limit of normal; alanine
aminotransferase [SGPT (ALT)] and aspartate aminotransferase [SGOT (AST)] < 5
times the institutional upper limit of normal.

- Renal: Serum creatinine which is less than 1.5x the upper limit of institutional
normal for age or Glomerular Filtration Rate (GFR) > 70 ml/min/1.73m2.

6. Female patients of childbearing potential must have negative serum or urine pregnancy
test. Patient must not be pregnant or breast feeding.

7. Patients of childbearing or child-fathering potential must be willing to use a
medically acceptable form of birth control, which includes abstinence, while being
treated on this study.

8. Ability to understand and the willingness to sign a written informed consent
document.

Exclusion Criteria:

1. Patients must not have any significant medical illnesses that in the investigator's
opinion cannot be adequately controlled with appropriate therapy or would compromise
the patient's ability to tolerate this therapy.

2. Patients receiving any other anticancer or experimental drug therapy.

3. Patients with disseminated intrinsic diffuse brainstem gliomas in either brain or
spine (can be based on clinical evaluation).

4. Participants receiving any medications or substances that are strong/intermediate
inhibitors or inducers of Cytochrome P450 (CYP450), Cytochrome P3A4(CYP3A4) or
Cytochrome 1A2 (CYP1A2) are ineligible. Lists including medications and substances
known or with the potential to interact with the CYP450 CYP3A4 or CYP1A2 isoenzymes
are provided in Appendix I.

5. Use of hematopoietic growth factors within the 2 weeks prior to initiation of
therapy.

6. Patients with evidence of spontaneous hemorrhage greater than 0.5cm unrelated to
surgery.

7. Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

8. Pregnant women are excluded from this study because bevacizumab, temozolomide and
erlotinib can have potential for teratogenic or abortifacient effects. Because there
is an unknown but potential risk of adverse events in nursing infants secondary to
treatment of the mother with these agents, breastfeeding should be discontinued.

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Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival of children and young adults with diffuse intrinsic pontine glioma treated with a molecularly based treatment strategy, compared to historical controls (COG ACNS0126)

Outcome Time Frame:

52 weeks

Safety Issue:

No

Principal Investigator

Mark W. Kieran, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

DFCI 10-321

NCT ID:

NCT01182350

Start Date:

September 2011

Completion Date:

Related Keywords:

  • Diffuse Intrinsic Pontine Glioma
  • Molecularly Determined Treatment
  • Glioma
  • Pontine Glioma

Name

Location

Children's Hospital of MichiganDetroit, Michigan  48201
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Doernbecher Children's HospitalPortland, Oregon  97201-3098
Miami Children's HospitalMiami, Florida  33155-4069
Washington University Medical CenterSaint Louis, Missouri  63105
Children's Hospitals and Clinics of MinnesotaSaint Paul, Minnesota  55102
University of California, San FranciscoSan Francisco, California  94143
Duke UniversityDurham, North Carolina  27710
University of LouisvilleLouisville, Kentucky  40202
Penn State Hershey Medical CenterHershey, Pennsylvania  17033
New York UniversityNew York, New York  10016
Children's Healthcare of AtlantaAtlanta, Georgia  30342
Ut Southwestern Medical CenterDallas, Texas  75390
Seattle Children's HospitalSeattle, Washington  98105
Johns HopkinsBaltimore, Maryland  21231
Cook Children's Medical CenterFort Worth, Texas  76104
Children's Hospital ColoradoAurora, Colorado  80045
Ann & Robert H Lurie Children's Hospital of ChicagoChicago, Illinois  60611