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
Hide Study Locations| United States, Alabama | |
| Children's Hospital of Alabama at University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Joseph G. Pressey 205-939-9285 | |
| United States, California | |
| Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | Recruiting |
| Long Beach, California, United States, 90801 | |
| Contact: Amanda M. Termuhlen 562-933-8605 | |
| Childrens Hospital Los Angeles | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Leo Mascarenhas 323-361-2529 | |
| Children's Hospital of Orange County | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Violet Shen 714-532-8636 | |
| Lucile Packard Children's Hospital at Stanford University Medical Center | Recruiting |
| Palo Alto, California, United States, 95798 | |
| Contact: Neyssa M. Marina 650-723-5535 | |
| UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |
| United States, Connecticut | |
| Connecticut Children's Medical Center | Recruiting |
| Hartford, Connecticut, United States, 06106 | |
| Contact: Clinical Trials Office - Connecticut Children's Medical Center 860-545-9967 | |
| United States, District of Columbia | |
| Children's National Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20010-2970 | |
| Contact: Clinical Trials Office - Children's National Medical Center 202-884-2549 | |
| United States, Florida | |
| Lee Cancer Care of Lee Memorial Health System | Recruiting |
| Fort Myers, Florida, United States, 33901 | |
| Contact: Clinical Trials Office - Lee Cancer Care of Lee Memorial Healt 877-680-0008 | |
| All Children's Hospital | Recruiting |
| Saint Petersburg, Florida, United States, 33701 | |
| Contact: Gregory A. Hale 727-767-4176 | |
| United States, Georgia | |
| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Todd M. Cooper 404-785-1838 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | Recruiting |
| Honolulu, Hawaii, United States, 96813 | |
| Contact: Clinical Trials Office - Cancer Research Center of Hawaii 808-586-2979 | |
| United States, Illinois | |
| University of Illinois Cancer Center | Recruiting |
| Chicago, Illinois, United States, 60612-7243 | |
| Contact: Clinical Trial Office - University of Illinois Cancer Center 312-355-3046 | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Recruiting |
| Maywood, Illinois, United States, 60153 | |
| Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center 708-226-4357 | |
| United States, Indiana | |
| Riley's Children Cancer Center at Riley Hospital for Children | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: James M. Croop 317-944-8784 | |
| St. Vincent Indianapolis Hospital | Recruiting |
| Indianapolis, Indiana, United States, 46260 | |
| Contact: Clinical Trials Office - St. Vincent Indianapolis Hospital 317-338-2194 | |
| United States, Iowa | |
| Blank Children's Hospital | Recruiting |
| Des Moines, Iowa, United States, 50309 | |
| Contact: Clinical Trials Office - Blank Children's Hospital 515-241-6729 | |
| United States, Kentucky | |
| Lucille P. Markey Cancer Center at University of Kentucky | Recruiting |
| Lexington, Kentucky, United States, 40536-0093 | |
| Contact: Clinical Trials Office - Markey Cancer Center at University of 859-257-3379 | |
| Kosair Children's Hospital | Recruiting |
| Louisville, Kentucky, United States, 40232 | |
| Contact: Clinical Trials Office - Kosair Children's Hospital 502-629-5500 CancerResource@nortonhealthcare.org | |
| United States, Louisiana | |
| Children's Hospital of New Orleans | Recruiting |
| New Orleans, Louisiana, United States, 70118 | |
| Contact: Clinical Trials Office - Children's Hospital of New Orleans 504-894-5377 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
| Baltimore, Maryland, United States, 21231-2410 | |
| Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu | |
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 2115 | |
| Contact: Carlos Rodriguez-Galindo 617-632-4580 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | Recruiting |
| Detroit, Michigan, United States, 48201-1379 | |
| Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363 | |
| Helen DeVos Children's Hospital at Spectrum Health | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Clinical Trials Office - Helen DeVos Children's Hospital 616-391-3050 | |
| United States, Minnesota | |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Recruiting |
| Minneapolis, Minnesota, United States, 55404 | |
| Contact: Clinical Trials Office - Children's Hospitals and Clinics of M 612-813-5193 | |
| United States, Missouri | |
| Children's Mercy Hospital | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: Maxine L. Hetherington 816-234-3265 | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Robert J. Hayashi 314-454-2041 | |
| United States, New Jersey | |
| Carol G. Simon Cancer Center at Morristown Memorial Hospital | Recruiting |
| Summit, New Jersey, United States, 07901 | |
| Contact: Steven L. Halpern 973-971-6720 | |
| United States, New Mexico | |
| University of New Mexico Cancer Center | Recruiting |
| Albuquerque, New Mexico, United States, 87131-5636 | |
| Contact: Clinical Trials Office - University of New Mexico Cancer Cente 505-272-6972 | |
| United States, New York | |
| NYU Cancer Institute at New York University Medical Center | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Linda Granowetter 212-263-8400 | |
| SUNY Upstate Medical University Hospital | Recruiting |
| Syracuse, New York, United States, 13210 | |
| Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi 315-464-5476 | |
| United States, North Carolina | |
| Blumenthal Cancer Center at Carolinas Medical Center | Recruiting |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas 704-355-2884 | |
| Presbyterian Cancer Center at Presbyterian Hospital | Recruiting |
| Charlotte, North Carolina, United States, 28233-3549 | |
| Contact: Clinical Trials Office - Presbyterian Cancer Center at Presbyt 704-384-5369 | |
| United States, Ohio | |
| Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205-2696 | |
| Contact: Laura T. Martin 614-722-3582 | |
| Dayton Children's - Dayton | Recruiting |
| Dayton, Ohio, United States, 45404-1815 | |
| Contact: Emmett H. Broxson 937-641-3111 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Rene Y. McNall-Knapp 405-271-5311 | |
| United States, Oregon | |
| Knight Cancer Institute at Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239-3098 | |
| Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea 503-494-1080 trials@ohsu.edu | |
| Legacy Emanuel Children's Hospital | Recruiting |
| Portland, Oregon, United States, 97227 | |
| Contact: Clinical Trials Office - Legacy Emanuel Children's Hospital 503-413-2560 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Elizabeth Fox 267-425-3010 | |
| United States, South Carolina | |
| Palmetto Health South Carolina Cancer Center | Recruiting |
| Columbia, South Carolina, United States, 29203 | |
| Contact: Clinical Trials Office - Palmetto Health South Carolina Cancer 803-434-3680 | |
| BI-LO Charities Children's Cancer Center | Recruiting |
| Greenville, South Carolina, United States, 29605 | |
| Contact: Nichole L. Bryant 864-455-8898 | |
| United States, South Dakota | |
| Sanford Cancer Center at Sanford USD Medical Center | Recruiting |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| Contact: Clinical Trials Office - Sanford Cancer Center 605-328-1367 | |
| United States, Tennessee | |
| St. Jude Children's Research Hospital | Recruiting |
| Memphis, Tennessee, United States, 38105 | |
| Contact: Clinical Trials Office - St. Jude Children's Research Hospital 901-595-4644 | |
| Vanderbilt-Ingram Cancer Center | Recruiting |
| Nashville, Tennessee, United States, 37232-6838 | |
| Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 | |
| United States, Texas | |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097 | |
| Cook Children's Medical Center - Fort Worth | Recruiting |
| Fort Worth, Texas, United States, 76104 | |
| Contact: Clinical Trials Office - Cook's Children's Medical Center 682-885-2103 | |
| United States, Utah | |
| Primary Children's Medical Center | Recruiting |
| Salt Lake City, Utah, United States, 84113-1100 | |
| Contact: Phillip E. Barnette 801-662-4700 | |
| United States, Wisconsin | |
| Midwest Children's Cancer Center at Children's Hospital of Wisconsin | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Michael E. Kelly 414-456-4170 | |
| Australia, Western Australia | |
| Princess Margaret Hospital for Children | Recruiting |
| Perth, Western Australia, Australia, 6001 | |
| Contact: Catherine H. Cole 011-6189340-8238 | |
| Canada, Ontario | |
| McMaster Children's Hospital at Hamilton Health Sciences | Recruiting |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Contact: Carol Portwine 905-521-2100x73464 | |
| 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 16, 2013