Phase
Condition
Brain Cancer
Brain Tumor
Gliomas
Treatment
Specialized Tumor Board Treatment Plan
Combinations
Clinical Study ID
Ages 12-39 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants must have recurrent medulloblastoma or recurrent ependymoma previouslyhistologically confirmed. Participants must be experiencing their first or secondrelapse to be eligible.
Participants must have surgically accessible disease.
Prior Therapy:
The participant must have received at least one prior therapy at the time ofinitial diagnosis.
Relapsed medulloblastoma or relapsed ependymoma are eligible.
Participants must have fully recovered from the acute toxic effects of allprior chemotherapy, immunotherapy, or radiotherapy prior to entering this studyand would be eligible for surgical resection per institutional guidelines
- Participants must have received last chemotherapy or biologic agent atleast 7 days prior to registration.
- Monoclonal antibody treatment: > 21 days prior to registration.
- Bevacizumab participants must have received last dose > 21 days prior tostudy registration
Participant must be a candidate for surgical resection or biopsy with anticipatedability to obtain the minimum tissue requirements for study.
Radiation - Participants must have:
Had their last fraction of local irradiation to primary tumor >= 12 weeks priorto registration.
Had their last fraction of craniospinal irradiation or total body irradiation >= 12 weeks prior to registration
At least 14 days after local palliative radiation (small-port)
Age >=12 months to <= 39 years of age.
Karnofsky >= 50 for participants > 16 years of age and Lansky >= 50 for participants <= 16 years of age. Participants who are unable to walk because of paralysis, butwho are up in a wheelchair, will be considered ambulatory for the purpose ofassessing the performance score.
Corticosteroids: Participants who are receiving dexamethasone or equivalent must beon a stable or decreasing dose for at least 1 week prior to registration.
Organ Function Requirements (within 7 days prior to study registration)
Adequate Bone Marrow Function Defined as:
- Peripheral absolute neutrophil count (ANC) >= 750/mm^3
- Platelet count >= 75,000/mm^3 (transfusion independent, defined as notreceiving platelet transfusions for at least 7 days prior to enrollment).
- Hemoglobin >= 8 g/dl.
- Adequate Renal Function Defined as:
- Creatinine clearance or radioisotope GFR >= 70 milliliter/minute (mL/min) /1.73 m^2 or
- A serum creatinine based on age/sex as follows:Age / Maximum Serum Creatinine (mg/dL) Male / Maximum Serum Creatinine (mg/dL)Female.
- 1 to < 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.
- >= 16 years / 1.7 / 1.4.
- The threshold creatinine values in this table were derived from theSchwartz formula for estimating Glomerular filtration rate (GFR)utilizing child length and stature data published by the Center forDisease Control (CDC) (Schwartz GJ and Gauthier B 1985).
- Adequate Liver Function Defined as:
- Total Bilirubin <= 1.5 x upper limit of normal (ULN) for age; in presenceof Gilbert's syndrome, total bilirubin < 3 x ULN or direct bilirubin < 1.5x ULN.
- Alanine aminotransferase (ALT) <= 3x ULN.
- Aspartate aminotransferase (AST) <= 3x ULN.
The effects of the agents used in this study on the developing human fetus areunknown. For this reason, women of child-bearing potential and men must agree to useadequate contraception (hormonal or barrier method of birth control; abstinence)prior to study entry, for the duration of study participation and 4 months aftercompletion of therapy administration. Should a woman become pregnant or suspectpregnancy while participating in this study, the treating physician should beinformed immediately.
Adequate neurologic function defined as participants with seizure disorder may beenrolled if seizures are well controlled. Participants on non-enzyme inducinganticonvulsants may be excluded pending interaction(s) with study drug.
Participants must enroll on the Protocol for Children and Young Adults Diagnosedwith a Central Nervous System (CNS) Tumor to Assess Cognitive, Quality of Life (QOL), and Comprehensive Effects of Therapies (PNOC COMP) study if PNOC COMP is opento accrual at the enrolling institution
A legal parent/guardian or participant must be able to understand, and willing tosign, a written informed consent and assent document, as appropriate.
Exclusion
Exclusion Criteria:
Participants who have had chemotherapy or radiotherapy within 3 weeks (6 weeks fornitrosoureas or mitomycin C) prior to entering the study or those who have notrecovered from adverse events due to agents administered more than 4 weeks earlier.
Participants who are receiving any other investigational agents.
Participants must be at least 7 days since the completion of therapy with a biologicor small molecule agent. For any agent with known adverse events that can occurbeyond 7 days after administration, the period prior to enrollment must be beyondthe time during which adverse events are known to occur. Such participants shouldalso be discussed with study chairs.
Participants who are currently taking any anti-cancer direct therapy. Steroids arenot considered anti-cancer therapy.
Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection.
Women of childbearing potential must not be pregnant or breast-feeding. A negativeserum or urine pregnancy test is required prior to start of therapy.
Participants must not receive any tumor-directed therapy after enrollment, exceptfor surgical resection/ biopsy.
Important note: The eligibility criteria listed above are interpreted literally and cannot be waived.
Study Design
Study Description
Connect with a study center
Children's Hospital of Los Angeles
Los Angeles, California 90027
United StatesActive - Recruiting
Rady Children's Hospital
San Diego, California 92123
United StatesActive - Recruiting
University of California, San Francisco
San Francisco, California 94143
United StatesActive - Recruiting
Children's National Hospital
Washington, District of Columbia 20010
United StatesActive - Recruiting
St. Louis Children's Hospital
Saint Louis, Missouri 63130
United StatesActive - Recruiting
St. Louis Children's Hospital / Washington University in St. Louis
Saint Louis, Missouri 63130
United StatesActive - Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
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