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New treatment option for Basal Ganglia Germinoma
Official title A Study of Lower Radiotherapy Dose to Treat Children With CNS Germinoma
ClinicalTrials.gov ID: NCT06368817
What this study is testing
What is Carboplatin?
Carboplatin is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for basal ganglia germinoma.
Also referred to as Blastocarb, Carboplat.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial studies how well lower dose radiotherapy after chemotherapy (Carboplatin \& Etoposide) works in treating children with central nervous system (CNS) germinomas. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 120 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 29
You may be able to join if
- Patients must be ≥ 3 years and \< 30 years at the time of study enrollment
- Patients must be newly-diagnosed primary localized germinoma of the suprasellar and/or pineal region by pathology and/or serum and/or CSF hCGbeta...
- Patients with EITHER (A) bifocal (pineal + suprasellar) involvement OR (B) pineal lesion with diabetes insipidus (DI) AND hCGbeta ≤ 100 mIU/mL in...
- Patients with hCGbeta 51-100 mIU/mL in serum and/or CSF and institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists) in both serum...
- Patients with germinoma of the basal ganglia and or/thalamic primary sites are eligible
You likely can't join if
- Patients with any of the following malignant pathological elements are not eligible:
- Endodermal sinus (yolk sac)
- Embryonal carcinoma, choriocarcinoma
- Malignant/immature teratoma and mixed germ cell tumor (GCT) (i.e., may include some germinoma)
- Patients with only mature teratoma upon tumor sampling at diagnosis and negative tumor markers are not eligible
- Patients who have received any prior tumor-directed therapy for their diagnosis of germinoma other than surgical intervention and corticosteroids are...
See the full eligibility criteria
Who can join
- Patients must be ≥ 3 years and \< 30 years at the time of study enrollment
- Patients must be newly-diagnosed primary localized germinoma of the suprasellar and/or pineal region by pathology and/or serum and/or CSF hCGbeta 5-50 mIU/mL AND institutional normal AFP (or ≤ 10 ng/mL if no...
- Patients with EITHER (A) bifocal (pineal + suprasellar) involvement OR (B) pineal lesion with diabetes insipidus (DI) AND hCGbeta ≤ 100 mIU/mL in serum and/or CSF AND institutional normal AFP (or ≤ 10 ng/mL if no...
- Patients with hCGbeta 51-100 mIU/mL in serum and/or CSF and institutional normal AFP (or ≤ 10 ng/mL if no institutional normal exists) in both serum and CSF. Histologic confirmation of germinoma IS required
- Patients with germinoma of the basal ganglia and or/thalamic primary sites are eligible
- Patients with metastatic germinoma including non-contiguous disease or distant disease in the brain, ventricles, or spine are eligible
- Patients with germinoma admixed with mature teratoma are eligible
- Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients ≤ 16 years of age
- Patients must have eligibility confirmed by Rapid Central Imaging Review performed on APEC14B1-CNS
- Imaging studies must be obtained within 31 days prior to study enrollment and start of protocol therapy. (Note: for patients that have had surgery and post-operative imaging performed, it is the post-operative MRI that...
- Patients must have a cranial magnetic resonance imaging (MRI) with and without gadolinium at diagnosis/prior to enrollment. If surgical resection is performed, patients must have pre-operative and post-operative brain...
- Patients must have a spine MRI with gadolinium obtained at diagnosis/prior to enrollment
- Patients must be enrolled, and protocol therapy must begin, no later than 31 days after definitive surgery or clinical diagnosis, whichever is later
- Patients must have eligibility confirmed by Rapid Central Tumor Marker Review performed on APEC14B1-CNS
- Lumbar CSF must be obtained prior to study enrollment unless medically contraindicated. If a patient undergoes surgery and lumbar CSF cytology cannot be obtained at the time of surgery, then it should be performed at...
- Patients must have CSF tumor markers obtained prior to study enrollment unless medically contraindicated. Ventricular CSF obtained at the time of CSF diversion procedure (if performed) is acceptable for tumor markers...
- For patients with solid tumors: Peripheral absolute neutrophil count (ANC) \>= 1000/uL (Must be performed within 7 days prior to enrollment unless otherwise indicated)
- For patients with solid tumors: Platelet count \>= 100,000/uL (transfusion independent) (Must be performed within 7 days prior to enrollment unless otherwise indicated)
- For patients with solid tumors: Hemoglobin \>= 8.0 g/dL (may receive red blood cell [RBC] transfusions) (Must be performed within 7 days prior to enrollment unless otherwise indicated)
- For pediatric patients (age 3-17 years): A serum creatinine based on age/sex as follows (Must be performed within 7 days prior to enrollment unless otherwise indicated):
- Age: 3 to \< 6 years; maximum serum creatinine (mg/dL): 0.8 (male); 0.8 (female)
- Age: 6 to \< 10 years; maximum serum creatinine (mg/dL): 1 (male); 1 (female)
- Age: 10 to \< 13 years; maximum serum creatinine (mg/dL): 1.2 (male); 1.2 (female)
- Age: 13 to \< 16 years; maximum serum creatinine (mg/dL): 1.5 (male); 1.4 (female)
- Age: ≥ 17 years; maximum serum creatinine (mg/dL): 1.7 (male); 1.4 (female) OR a 24-hour urine creatinine clearance ≥ 70 mL/min/1.73 m\^2 OR a glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m\^2. GFR must be...
- Note: Estimated GFR (eGFR) from serum or plasma creatinine, cystatin C or other estimates are not acceptable for determining eligibility.
- For adult patients (age 18 years or older) (Must be performed within 7 days prior to enrollment unless otherwise indicated):
- Creatinine clearance ≥ 70 mL/min, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection. The creatinine value used in the calculation must have been obtained within 28 days prior to registration...
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age (Must be performed within 7 days prior to enrollment unless otherwise indicated)
- Serum glutamic-pyruvic transaminase (SGPT) (alanine transaminase [ALT]) ≤ 135 U/L (Must be performed within 7 days prior to enrollment unless otherwise indicated)
- Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
- No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \> 94% if there is clinical indication for determination
- Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
- CNS toxicity =\< grade 2
- Patients must not be in status epilepticus, coma or assisted ventilation prior to study enrollment
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load are eligible for this study
What rules you out
- Patients with any of the following malignant pathological elements are not eligible:
- Endodermal sinus (yolk sac)
- Embryonal carcinoma, choriocarcinoma
- Malignant/immature teratoma and mixed germ cell tumor (GCT) (i.e., may include some germinoma)
- Patients with only mature teratoma upon tumor sampling at diagnosis and negative tumor markers are not eligible
- Patients who have received any prior tumor-directed therapy for their diagnosis of germinoma other than surgical intervention and corticosteroids are not eligible
- Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
- Note: Serum and urine pregnancy tests may be falsely positive due to HCGbeta-secreting germ cell tumors. Ensure the patient is not pregnant by institutional standards
- Lactating females who plan to breastfeed their infants
- Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
The study team makes the final eligibility decision.
Where it's taking place
- Mobile, Alabama, United States
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Loma Linda, California, United States
- Los Angeles, California, United States
- Oakland, California, United States
- Orange, California, United States
- Palo Alto, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Hartford, Connecticut, United States
- New Haven, Connecticut, United States
- Wilmington, Delaware, United States
- Washington D.C., District of Columbia, United States
- Hollywood, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Pensacola, Florida, United States
+ 75 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 120 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 29 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mobile, Alabama, United States; Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Loma Linda, California, United States; Los Angeles, California, United States; Oakland, California, United States and 89 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.