p28 in Treating Younger Patients With Recurrent or Progressive Central Nervous System Tumors

Completed · Phase 1

Conditions studied: Teratoid Tumor, Atypical, Choroid Plexus Neoplasms, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Brainstem Tumors, Giant Cell Glioblastoma, Glioblastoma, Gliosarcoma, Medulloblastoma, Neuroectodermal Tumor, Primitive

In brief

This phase I trial studies the side effects and best dose of azurin-derived cell-penetrating peptide p28 (p28) in treating patients with recurrent or progressive central nervous system tumors. Drugs used in chemotherapy, such as azurin-derived cell-penetrating peptide p28, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Key facts

Study ID: NCT01975116
Run by: Pediatric Brain Tumor Consortium
People needed: 18
Starts: 2013-08-01
Expected to finish: 2015-04-01
Last updated by the study team: 2017-08-07

Who can join

Age: 3 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologically confirmed primary progressive, recurrent or refractory CNS tumors with no known curative therapies limited to high grade glioma, such as glioblastoma multiforme, medulloblastoma, primitive neuroectodermal tumor, atypical teratoid/rhabdoid tumor, anaplastic astrocytoma, high-grade astrocytoma not otherwise specified (NOS), anaplastic oligodendroglioma, or choroid plexus carcinoma; or diffuse intrinsic pontine glioma; the requirements for histological verification are waived for diffuse intrinsic pontine glioma
Patients must not have received myelosuppressive chemotherapy or immunotherapy within 3 weeks of registration (6 weeks if prior nitrosourea)
Patients must have received their last dose of biologic agent >= 7 days prior to study registration
Steroid dose should be stable or decreasing for at least 1 week prior to registration
If prior therapy was monoclonal antibody, 30 days or 3 half-lives must have elapsed (whichever is longer), prior to registration
Patient must be off all colony stimulating factors > 1 week prior to registration (filgrastim [GCSF], sargramostim [GM CSF], erythropoietin)
Any craniospinal irradiation must have taken place >= 3 months prior to registration >= 8 weeks for local irradiation to primary tumor; >= 2 weeks prior to study entry for focal irradiation for symptomatic metastatic sites
Karnofsky performance scale (KPS) (for > 16 years [yrs] of age) or Lansky performance score (LPS) (for =< 16 years of age) >= 50 assessed within two weeks prior to registration
Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration
Absolute neutrophil count >= 1000/ mm\^3 (unsupported)
Platelets >= 100,000/ mm\^3 (unsupported)
Hemoglobin >= 8g/dL (with or without packed red blood cells [PRBC] transfusion)
Total bilirubin =< 1.5 times upper limit of normal for age
Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 times institutional upper limit of normal for age
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 3.0 times institutional upper limit of normal for age
Blood glucose within normal limits for age (If above institutional normal limits must be repeated as fasting and then within normal limits [WNL] for age)
Creatinine clearance or nuclear glomerular filtration rate (GFR) >= 70 mL/min/1.73 m\^2 or a serum creatinine based on age as follows:
=< 5 years: 0.8 mg/dL
> 5 to =< 10 years: 1 mg/dL
> 10 to =< 15 years: 1.2 mg/dL
> 15 years: 1.5 mg/dL
Albumin >= 2 g/dL
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
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 and for 6 months after the last drug administration
Ability of subject or parent/guardian to understand and the willingness to sign a written informed consent document

You may not qualify if…

Patients who are receiving any other investigational agents
Patients with known inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy
Only tumor types listed above are allowed; low grade gliomas (with and without neurofibromin 1 [NF1]) and ependymomas are excluded
History of hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to murine protein-containing products
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
Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with p28

Where it is running

Children's Hospital Los Angeles — Los Angeles, California, United States
Lucile Packard Children's Hospital Stanford University — Palo Alto, California, United States
Children's National Medical Center — Washington D.C., District of Columbia, United States
Lurie Children's Hospital-Chicago — Chicago, Illinois, United States
National Cancer Institute Pediatric Oncology Branch — Bethesda, Maryland, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
Duke University Medical Center — Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
St. Jude Children's Research Hospital — Memphis, Tennessee, United States
Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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