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

Inclusion Criteria:

• There is no age limit for the low risk stratum (stage I ovarian immature teratomaand 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 stageI germ cell tumor; for the standard risk arms, patients must be newly diagnosed withmetastatic germ cell tumor (stage II or higher); histologic confirmation of aprimary extracranial germ cell tumor in any of the categories outlined below isrequired of all patients at enrollment except for those who were initially diagnosedwith stage I non-seminoma malignant GCT and later recur during observation postsurgery off study; for these patients, if elevated tumor markers rise to > 5 x upperlimit of normal (ULN) on at least 2 measurements taken at least 1 week apart, adiagnostic biopsy is not required for enrollment

• Low risk stage I immature teratoma (IT); site: ovarian; stage: Children's OncologyGroup (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 ofyolk sac tumor), mixed immature and mature teratoma, (no pathological evidence ofMGCT); tumor markers: alpha-FP =< 1,000 ng/mL, beta-HCG institutional normal; allages

• 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 thefollowing: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed);all ages

• Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCCtesticular stage IA IB, and IS; histology: may contain immature/mature teratoma; mayNOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages

• Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stageII-IV, FIGO stage IC, FIGO stage II-IV (International Germ Cell ConsensusClassification [IGCCC] criteria DO NOT apply); histology: must contain at least oneof 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 goodrisk; post op: alpha-FP < 1,000 ng/mL, beta-HCG < 5,000 IU/mL and lactatedehydrogenase (LDH) < 3.0 x normal; age (years) >= 11 and < 25

• Site: extragonadal; stage: COG stage II; histology: must contain at least oneof 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 thestudy

• For the low risk stage I non-seminoma MGCT and the standard risk arms,components of yolk sac tumor, embryonal carcinoma, or choriocarcinoma can bemixed 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 bedeemed by the pathologist to be greater than a "microscopic component" of yolksac tumor

• Patients must have a performance status corresponding to Eastern CooperativeOncology Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients > 16 yearsof 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) >= 70mL/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 toenrollment): (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 toenrollment)

• Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) orserum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5x upper limit of normal (ULN) for age (for the purpose of this study, the ULN forSGPT is 45 U/L) (within 7 days prior to enrollment)

• Peripheral absolute neutrophil count (ANC) >= 1,000/mm^3 (within 7 days prior toenrollment) 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 receiveprotocol 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 willnot receive AGCT1531 protocol-directed therapy; all other AYA-HEARS patients must beenrolled 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 formalignancy 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 orIV 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 CNSirradiation of brain metastases; (this exception only applies to SR1 patients; anypatients over age 11 with distant metastases to brain [stage IV disease] would beconsidered poor risk and therefore not eligible for this trial)

• Patients with significant, pre-existing co-morbid respiratory disease thatcontraindicate the use of bleomycin are ineligible for the standard risk arms of thetrial

• Female patients who are pregnant since fetal toxicities and teratogenic effects havebeen noted for several of the study drugs; a pregnancy test is required for femalepatients of childbearing potential; (this criteria applies ONLY to patients who willreceive chemotherapy [SR1 and SR2 patients])

• Lactating females who plan to breastfeed their infants; (this criteria applies ONLYto patients who will receive chemotherapy [SR1 and SR2 patients])

• Sexually active patients of reproductive potential who have not agreed to use aneffective contraceptive method for the duration of their study participation; (thiscriteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2patients])