Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
Launched by CHILDREN'S ONCOLOGY GROUP · Feb 23, 2017
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating how well doctors can monitor patients with low-risk germ cell tumors after surgery, to see if the tumors come back. It also looks at whether two chemotherapy drugs, carboplatin and cisplatin, are more effective for treating patients whose tumors have spread. The trial is open to both children and adults with specific types of germ cell tumors, including certain stages of ovarian and testicular cancers.
To be eligible, patients must be newly diagnosed with either low-risk or standard-risk germ cell tumors based on certain criteria, such as age and tumor characteristics. Participants can expect to be monitored closely, and those in the standard-risk group may receive chemotherapy. It’s important for potential participants to know that there are specific health criteria they must meet to join, and women who are pregnant or breastfeeding cannot participate. Overall, this trial aims to improve treatment and monitoring strategies for germ cell tumors in patients of all ages.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT \[all sites\])
- • Standard risk 1: Patients must be \< 11 years of age at enrollment
- • Standard risk 2: Patients must be \>= 11 and \< 25 years of age at enrollment
- • Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with metastatic germ cell tumor (stage II or higher); histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment except for those who were initially diagnosed with stage I non-seminoma malignant GCT and later recur during observation post surgery off study; for these patients, if elevated tumor markers rise to \> 5 x upper limit of normal (ULN) on at least 2 measurements taken at least 1 week apart, a diagnostic biopsy is not required for enrollment
- • Low risk stage I immature teratoma (IT); site: ovarian; stage: Children's Oncology Group (COG) stage I, Federation of Gynecology and Obstetrics (FIGO) stage IA and IB; grade: 2 or 3; histology: pure immature teratoma (may contain microscopic foci of yolk sac tumor), mixed immature and mature teratoma, (no pathological evidence of MGCT); tumor markers: alpha-FP =\< 1,000 ng/mL, beta-HCG institutional normal; all ages
- • Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA, IB and IS; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages
- • Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCC testicular stage IA IB, and IS; histology: may contain immature/mature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages
- • Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC, FIGO stage II-IV (International Germ Cell Consensus Classification \[IGCCC\] criteria DO NOT apply); histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) \< 11
- • Standard risk 2 (SR2)
- • Site: ovarian; stage: COG stage II and III, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) \>= 11 and \< 25
- • Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; tumor markers: must be IGCCC good risk; post op: alpha-FP \< 1,000 ng/mL, beta-HCG \< 5,000 IU/mL and lactate dehydrogenase (LDH) \< 3.0 x normal; age (years) \>= 11 and \< 25
- • Site: extragonadal; stage: COG stage II; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) \>= 11 and \< 25
- * Notes:
- • IGCCC criteria only apply to SR2 patients with a testicular primary tumor
- • Use post-op tumor marker levels to determine IGCCC risk group
- • Stage 1 seminoma patients are not eligible for the standard risk arms of the study
- • For the low risk stage I non-seminoma MGCT and the standard risk arms, components of yolk sac tumor, embryonal carcinoma, or choriocarcinoma can be mixed with other forms of GCT, such as seminoma or mature or immature teratoma; if yolk sac tumor is the only malignant component present, then it must be deemed by the pathologist to be greater than a "microscopic component" of yolk sac tumor
- • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age
- • Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients)
- * Adequate renal function defined as:
- • Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 (within 7 days prior to enrollment) OR
- • A serum creatinine based on age/gender as follows (within 7 days prior to enrollment): (mg/dL)
- • 1 month to \< 6 months male: 0.4 female: 0.4
- • 6 months to \< 1 year male: 0.5 female: 0.5
- • 1 to \< 2 years male: 0.6 female: 0.6
- • 2 to \< 6 years male: 0.8 female: 0.8
- • 6 to \< 10 years male: 1 female: 1
- • 10 to \< 13 years male: 1.2 female: 1.2
- • 13 to \< 16 years: male: 1.5 female: 1.4
- • \>= 16 years male: 1.7 female: 1.4
- • Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
- • Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 2.5 x upper limit of normal (ULN) for age (for the purpose of this study, the ULN for SGPT is 45 U/L) (within 7 days prior to enrollment)
- • Peripheral absolute neutrophil count (ANC) \>= 1,000/mm\^3 (within 7 days prior to enrollment) AND
- • Platelet count \>= 100,000/mm\^3 (within 7 days prior to enrollment)
- • Patients enrolling on the standard risk arms must be medically fit to receive protocol treatment and with no contraindications to protocol treatment
- • Eligibility criteria to participate in the pilot study of the AYA-Hears instrument (patient reported outcomes \[PROs\] of ototoxicity) Note: participants in group 1 will not receive AGCT1531 protocol-directed therapy; all other AYA-HEARS patients must be enrolled on the AGCT1531 SR2 arm in order to participate
- • \>= 11 and \< 25 years old at enrollment
- • Able to fluently speak and read English
- • Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor
- * Followed for cancer or survivorship care at one of the following institutions:
- • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
- • Dana Farber/Harvard Cancer Center
- • Hospital for Sick Children
- • Children's Hospital of Eastern Ontario
- • Oregon Health and Science University
- • Seattle Children's Hospital
- • Yale University
- Exclusion Criteria:
- * Patients with any diagnoses not listed including:
- • Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection)
- • Pure dysgerminoma
- • Pure mature teratoma
- • Pure immature teratoma COG stage I, grade I
- • Pure immature teratoma COG stage I, grade 2,3 with alpha-fetoprotein (AFP) \>= 1000 ng/mL
- • Pure immature teratoma COG stage II - IV or FIGO stage IC to IV
- • "Poor risk" GCT (age \>= 11 years old and COG stage IV ovarian, COG stage III or IV EG, or IGCCC intermediate or poor risk testicular), or
- • Primary central nervous system (CNS) germ cell tumor
- • Germ cell tumor with somatic malignant transformation
- • Spermatocytic seminoma
- • Patients must have had no prior systemic therapy for the current cancer diagnosis
- • Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain metastases; (this exception only applies to SR1 patients; any patients over age 11 with distant metastases to brain \[stage IV disease\] would be considered poor risk and therefore not eligible for this trial)
- • Patients with significant, pre-existing co-morbid respiratory disease that contraindicate the use of bleomycin are ineligible for the standard risk arms of the trial
- • 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; (this criteria applies ONLY to patients who will receive chemotherapy \[SR1 and SR2 patients\])
- • Lactating females who plan to breastfeed their infants; (this criteria applies ONLY to patients who will receive chemotherapy \[SR1 and SR2 patients\])
- • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation; (this criteria applies ONLY to patients who will receive chemotherapy \[SR1 and SR2 patients\])
About Children's Oncology Group
The Children's Oncology Group (COG) is a leading national organization dedicated to improving the care and outcomes of children with cancer through collaborative research and clinical trials. Comprising a network of pediatric oncology experts, COG focuses on developing innovative treatment protocols, advancing scientific knowledge, and enhancing the quality of life for young patients. By fostering interdisciplinary collaboration and utilizing a comprehensive approach to childhood cancer, COG aims to translate research findings into effective therapies, ultimately striving for a cure for all children diagnosed with cancer.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New Haven, Connecticut, United States
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Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
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Dixon, Illinois, United States
Washington, Illinois, United States
Farmington, Missouri, United States
Henderson, Nevada, United States
Henderson, Nevada, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Santa Rosa, California, United States
Colorado Springs, Colorado, United States
Fort Collins, Colorado, United States
Greeley, Colorado, United States
Salisbury, North Carolina, United States
West Yorkshire, England, United Kingdom
Carmichael, California, United States
Dublin, Ohio, United States
Glasgow, Scotland, United Kingdom
Spartanburg, South Carolina, United States
Spartanburg, South Carolina, United States
Lone Tree, Colorado, United States
Little Rock, Arkansas, United States
East Lansing, Michigan, United States
Napa, California, United States
Boston, Massachusetts, United States
Providence, Rhode Island, United States
Niigata, Chuo Ku, Japan
Higashi Ku, Fukuoka, Japan
Chuo Ku, Saitama, Japan
Kyoto, , Japan
Nishinomiya, Hyogo, , Japan
Osaka City, , Japan
Tokyo, , Japan
Nampa, Idaho, United States
Springfield, Illinois, United States
Grand Island, Nebraska, United States
Perrysburg, Ohio, United States
Toledo, Ohio, United States
Lexington, Kentucky, United States
Aurora, Colorado, United States
Pekin, Illinois, United States
Mineola, New York, United States
Macon, Georgia, United States
Indianapolis, Indiana, United States
Des Moines, Iowa, United States
Edinburgh, Scotland, United Kingdom
London, England, United Kingdom
Mount Sterling, Kentucky, United States
Lebanon, New Hampshire, United States
Wyoming, Michigan, United States
Grand Rapids, Michigan, United States
Muskegon, Michigan, United States
Danville, Illinois, United States
West Palm Beach, Florida, United States
Los Angeles, California, United States
Osage Beach, Missouri, United States
Quebec, , Canada
Ankeny, Iowa, United States
Sunset Hills, Missouri, United States
Marysville, Ohio, United States
Niles, Michigan, United States
Reed City, Michigan, United States
Saint Joseph, Michigan, United States
O'fallon, Illinois, United States
Clive, Iowa, United States
Carmichael, California, United States
Grand Rapids, Michigan, United States
Escanaba, Michigan, United States
Saint Joseph, Michigan, United States
Jefferson City, Missouri, United States
Madison, Wisconsin, United States
Wilmington, Ohio, United States
Silverdale, Washington, United States
Grand Rapids, Michigan, United States
Johnson Creek, Wisconsin, United States
Johnson Creek, Wisconsin, United States
Royal Oak, Michigan, United States
Chiba Sgi, Chiba, Japan
Pickerington, Ohio, United States
Westerville, Ohio, United States
Broomhall, England, United Kingdom
Manchester, England, United Kingdom
West Yorkshire, , United Kingdom
Atlanta, Georgia, United States
Detroit, Michigan, United States
Kalamazoo, Michigan, United States
Kearney, Nebraska, United States
Ankeny, Iowa, United States
Clive, Iowa, United States
Des Moines, Iowa, United States
Denver, Colorado, United States
Patients applied
Trial Officials
A. L Frazier
Principal Investigator
Children's Oncology Group
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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