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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pediatric Brain Tumor Consortium
• Collaborator: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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