Phase
Condition
Neoplasms
Testicular Cancer
Oligodendroglioma
Treatment
N/AClinical Study ID
Ages 3-21 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients must have histologically confirmed primary progressive, recurrent orrefractory 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 nototherwise specified (NOS), anaplastic oligodendroglioma, or choroid plexus carcinoma;or diffuse intrinsic pontine glioma; the requirements for histological verificationare 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 studyregistration
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 forfocal irradiation for symptomatic metastatic sites
Karnofsky performance scale (KPS) (for > 16 years [yrs] of age) or Lansky performancescore (LPS) (for =< 16 years of age) >= 50 assessed within two weeks prior toregistration
Patients with neurological deficits should have deficits that are stable for a minimumof 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]) =< 3.0times 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 mustbe 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^2or 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 urinepregnancy test
Patients of childbearing or child fathering potential must be willing to use amedically acceptable form of birth control, which includes abstinence, while beingtreated 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 awritten informed consent document
Exclusion
Exclusion Criteria:
Patients who are receiving any other investigational agents
Patients with known inability to return for follow-up visits or obtain follow-upstudies required to assess toxicity to therapy
Only tumor types listed above are allowed; low grade gliomas (with and withoutneurofibromin 1 [NF1]) and ependymomas are excluded
History of hypersensitivity reactions attributed to compounds of similar chemical orbiologic composition to murine protein-containing products
Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliance withstudy requirements
Pregnant women are excluded from this study; breastfeeding should be discontinued ifthe mother is treated with p28
Study Design
Study Description
Connect with a study center
Children's Hospital Los Angeles
Los Angeles, California 90027
United StatesSite Not Available
Lucile Packard Children's Hospital Stanford University
Palo Alto, California 94304
United StatesSite Not Available
Children's National Medical Center
Washington, District of Columbia 20010
United StatesSite Not Available
Children's National Medical Center
Washington, D.C., District of Columbia 20010
United StatesSite Not Available
Lurie Children's Hospital-Chicago
Chicago, Illinois 60614
United StatesSite Not Available
National Cancer Institute Pediatric Oncology Branch
Bethesda, Maryland 20892
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27710
United StatesSite Not Available
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesSite Not Available
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania 15224
United StatesSite Not Available
St. Jude Children's Research Hospital
Memphis, Tennessee 38105
United StatesSite Not Available
Baylor College of Medicine
Houston, Texas 77030
United StatesSite Not Available

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