Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors
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Purpose
RATIONALE: Drugs used as chemotherapy, such as carboplatin, etoposide, and ifosfamide work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x rays to kill tumor cells. Giving chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial studies how well chemotherapy and radiation therapy work in treating younger patients with newly diagnosed central nervous system germ cell tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: carboplatin Drug: etoposide Drug: ifosfamide Procedure: therapeutic conventional surgery Radiation: 3-dimensional conformal radiation therapy Radiation: intensity-modulated radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 2 Trial of Response-Based Radiation Therapy for Patients With Localized Central Nervous System Germ Cell Tumors (CNS GCT) |
- 3-year PFS rate with NGGCT [ Designated as safety issue: No ]
- PFS distribution of localized CNS germinoma at 3 years [ Designated as safety issue: No ]
- Neurocognitive function from baseline to up to 5 years using the ALTE07C1 protocol [ Designated as safety issue: No ]
- Estimation of the PFS distribution of patients with NGGCT treated with IFR assessed up to 5 years [ Designated as safety issue: No ]
- Estimation of the OS distribution of patients with NGGCT treated with IFR assessed up to 5 years [ Designated as safety issue: No ]
- Estimation of the PFS distribution of patients with localized germinoma patients and CSF serum hCGβ ≤ 50 mIU/mL or CSF serum hCGβ > 50 mIU/mL and ≤ 100 mIU/mL assessed up to 5 years [ Designated as safety issue: No ]
- Estimation of the OS distribution of patients with localized germinoma patients and CSF serum hCGβ ≤ 50 mIU/mL or CSF serum hCGβ > 50 mIU/mL and ≤ 100 mIU/mL assessed up to 5 years [ Designated as safety issue: No ]
| Estimated Enrollment: | 168 |
| Study Start Date: | May 2012 |
| Estimated Primary Completion Date: | January 2024 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 3 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Patients must be newly diagnosed with localized primary CNS nongerminomatous germ cell tumor (NGGCT) (Stratum 1) or localized primary CNS germinoma (Stratum 2); germ cell tumors (GCTs) located in the suprasellar, pineal, bifocal (pineal + suprasellar), and ventricles are eligible; tumors present in the above mentioned locations and with unifocal parenchymal extension are eligible
Stratum 1( NGGCT): Patients must have one of the following criteria:
- Patients with serum and/or CSF hCGβ > 100 mIU/mL or any elevation of serum and CSF alpha-fetoprotein (AFP) > 10 ng/mL or greater than the institutional normal are eligible, irrespective of biopsy results
- Patients with any of the following elements on biopsy/resection are eligible, irrespective of serum and/or CSF hCGβ and AFP levels: endodermal sinus tumor (yolk sac), embryonal carcinoma, choriocarcinoma, malignant/immature teratoma, and mixed GCT with malignant GCT elements
Stratum 2 (Germinoma): Patients must have one of the following criteria:
- Patients with institutional normal AFP AND hCGβ 5 to ≤ 50 mIU/mL in serum and/or CSF are eligible; no histologic confirmation required
- Patients with bifocal (pineal + suprasellar) involvement or pineal lesion with diabetes insipidus AND hCGβ ≤ 100 mIU/mL and institutional normal AFP in serum and/or CSF are eligible; no histologic confirmation required
- Patients with histologically confirmed germinoma or germinoma mixed with mature teratoma and hCGβ ≤ 100 mIU/mL and institutional normal AFP in serum and/or CSF are eligible
- Patients must have negative lumbar CSF cytology; lumbar CSF must be obtained unless medically contraindicated
- Patients must be enrolled on ALTE07C1 prior to enrollment on ACNS1123
- Patients with mature teratoma with normal tumor markers are not eligible
- Patients with tumors located outside the ventricles (basal ganglia, thalamus) are not eligible
- Patients with metastatic disease by either MRI evaluation or lumbar CSF cytology are not eligible
PATIENT CHARACTERISTICS:
- Peripheral absolute neutrophil count (ANC) ≥ 1,000/μL
- Platelet count ≥ 100,000/μL (transfusion independent)
- Hemoglobin ≥ 8.0 g/dL (may receive red blood cell [RBC] transfusions)
Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m² OR serum creatinine based on age/gender as follows:
- 0.4 mg/dL ( 1 month to < 6 months of age)
- 0.5 mg/dL (6 months to < 1 year of age)
- 0.6 mg/dL (1 to < 2 years of age)
- 0.8 mg/dL (2 to < 6 years of age)
- 1.0 mg/dL (6 to < 10 years of age)
- 1.2 mg/dL (10 to < 13 years of age)
- 1.5 mg/dL (male) and 1.4 mg/dL (female) (13 to < 16 years of age)
- 1.7 mg/dL (male) and 1.4 mg/dL (female) (≥ 16 years of age)
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 times ULN
- Patients with seizure disorder may be enrolled if well controlled
- Patients must not be in status, coma, or assisted ventilation prior to study enrollment
- Female patients who are pregnant are ineligible
- Lactating females are not eligible unless they have agreed not to breastfeed their infants
- Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
- Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
PRIOR CONCURRENT THERAPY:
- Patients who had more than 1 prior surgery/biopsy are eligible
- Patients must not have received any prior tumor-directed therapy other than surgical intervention and corticosteroids
Contacts and Locations
Show 50 Study Locations| Principal Investigator: | Ute K. Bartels, MD | The Hospital for Sick Children |
More Information
Additional Information:
No publications provided
| Responsible Party: | Peter C. Adamson, Children's Oncology Group - Group Chair Office |
| ClinicalTrials.gov Identifier: | NCT01602666 History of Changes |
| Other Study ID Numbers: | CDR0000734032, COG-ACNS1123 |
| Study First Received: | May 18, 2012 |
| Last Updated: | November 15, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
childhood central nervous system choriocarcinoma childhood central nervous system embryonal tumor childhood central nervous system germ cell tumor childhood central nervous system germinoma |
childhood central nervous system mixed germ cell tumor childhood central nervous system teratoma childhood central nervous system yolk sac tumor childhood pineal parenchymal tumor |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms, Germ Cell and Embryonal Neoplasms by Site Neoplasms Nervous System Diseases Neoplasms by Histologic Type Etoposide Isophosphamide mustard |
Ifosfamide Carboplatin Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013