Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors

This study is currently recruiting participants.
Verified November 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01602666
First received: May 18, 2012
Last updated: November 15, 2012
Last verified: November 2012
  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)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602666

  Show 50 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
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