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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Active Surveillance, Bleomycin, Carboplatin, Etoposide, or Cisplatin in Treating Pediatric and Adult Patients with Germ Cell Tumors

This phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Germ Cell (Pediatrics), Gynecologic, Ovarian
Phase III
Children
Chemotherapy - cytotoxic, Mol. targeted/Immunotherapy/Biologics
Bleomycin, Carboplatin, Cisplatin, Etoposide, Filgrastim (GCSF), Pegfilgrastim
Borinstein, Scott
National
Vanderbilt University
03-23-2018
Treatment
COGAGCT1531
NCT03067181

Eligibility

0 Years
BOTH
NO
Inclusion Criteria:

Low risk stratum (stage I ovarian immature teratoma and stage I malignant GCT [all sites]): Patients must be
Standard risk 1: Patient must be
Standard risk 2: Patients must be >= 11 and
Newly diagnosed patients must have histologic verification of a primary extracranial germ cell tumor in any of the categories outlined; elevation of serum tumor markers without histologic confirmation is not sufficient for entry on the trial * NOTE: for low risk patients, materials for rapid surgical central review must be sent within 7 days of study 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 =
Low risk stage I MCGT; 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); age (years)
Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC, FIGO stage II-IV; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); age (years)
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 (pure or mixed); age (years) >= 11 and = 11 and = 11 and
Notes: * IGCCC criteria only apply to SR2 patients with a testicular primary tumor * Use post-op tumor marker levels to determine IGCCC risk group * For the low risk stage I 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 (i.e. > 5%)

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 =
Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients)

Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2

A serum creatinine based on age/gender as follows: (mg/dL) * 1 month to = 16 years male: 1.7 female: 1.4

Total bilirubin =
Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT])
No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% if there is clinical indication or determination; pulmonary function tests (PFTs) are not required

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
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: * 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

Has experienced prior or ongoing hearing impairment due to chemotherapy or radiotherapy as defined by one of the following: * Society of Pediatric Oncology (SIOP) grade 1 hearing loss * Subjective (patient-reported) hearing difficulties * Subjective (patient-reported) tinnitus



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 and pure seminoma * 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

Patients must have had no prior systemic therapy

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 respiratory compromise due to either abdominal tumor limiting diaphragmatic excursion or pulmonary metastases should not receive bleomycin and are ineligible for 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])

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