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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03067181
Recruitment Status : Recruiting
First Posted : March 1, 2017
Last Update Posted : November 18, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Childhood Extracranial Germ Cell Tumor Extragonadal Embryonal Carcinoma Germ Cell Tumor Malignant Germ Cell Tumor Malignant Ovarian Teratoma Stage I Ovarian Choriocarcinoma Stage I Ovarian Embryonal Carcinoma AJCC v6 and v7 Stage I Ovarian Teratoma AJCC v6 and v7 Stage I Ovarian Yolk Sac Tumor AJCC v6 and v7 Stage I Testicular Choriocarcinoma AJCC v6 and v7 Stage I Testicular Embryonal Carcinoma AJCC v6 and v7 Stage I Testicular Yolk Sac Tumor AJCC v6 and v7 Stage II Ovarian Choriocarcinoma Stage II Ovarian Embryonal Carcinoma AJCC v6 and v7 Stage II Ovarian Yolk Sac Tumor AJCC v6 and v7 Stage II Testicular Choriocarcinoma AJCC v6 and v7 Stage II Testicular Embryonal Carcinoma AJCC v6 and v7 Stage II Testicular Yolk Sac Tumor AJCC v6 and v7 Stage III Ovarian Choriocarcinoma Stage III Ovarian Embryonal Carcinoma AJCC v6 and v7 Stage III Ovarian Yolk Sac Tumor AJCC v6 and v7 Stage III Testicular Choriocarcinoma AJCC v6 and v7 Stage III Testicular Embryonal Carcinoma AJCC v6 and v7 Stage III Testicular Yolk Sac Tumor AJCC v6 and v7 Stage IV Ovarian Choriocarcinoma Stage IV Ovarian Embryonal Carcinoma AJCC v6 and v7 Stage IV Ovarian Yolk Sac Tumor AJCC v6 and v7 Testicular Mixed Choriocarcinoma and Embryonal Carcinoma Testicular Mixed Choriocarcinoma and Teratoma Testicular Mixed Choriocarcinoma and Yolk Sac Tumor Other: Best Practice Drug: Bleomycin Biological: Bleomycin Sulfate Drug: Carboplatin Drug: Cisplatin Drug: Etoposide Drug: Etoposide Phosphate Other: Laboratory Biomarker Analysis Other: Pharmacogenomic Study Other: Quality-of-Life Assessment Other: Questionnaire Administration Phase 3

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients With Germ Cell Tumors
Actual Study Start Date : May 8, 2017
Estimated Primary Completion Date : June 30, 2027
Estimated Study Completion Date : June 30, 2027


Arm Intervention/treatment
Experimental: Arm I (bleomycin, carboplatin, etoposide)
Patients receive bleomycin IV over 10 minutes and carboplatin IV over 1 hour on day 1. Patients also receive etoposide IV over 1-2 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Drug: Bleomycin
Given IV
Other Names:
  • BLEO
  • BLM

Biological: Bleomycin Sulfate
Given IV
Other Names:
  • Blanoxan
  • BleMomycine
  • Blenoxane
  • Bleo-cell
  • Bleo-S
  • Bleocin
  • Bleolem
  • Bleomycin Sulfas
  • Bleomycin Sulphate
  • Bleomycini Sulfas
  • Blexane
  • Oil Bleo

Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carboplatinum
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo

Drug: Etoposide
Given IV
Other Names:
  • Demethyl Epipodophyllotoxin Ethylidine Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16
  • VP 16-213
  • VP-16
  • VP-16-213
  • VP16

Drug: Etoposide Phosphate
Given IV
Other Name: Etopophos

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Pharmacogenomic Study
Correlative studies
Other Name: PHARMACOGENOMIC

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Experimental: Arm II (bleomycin, etoposide, cisplatin)
Patients receive bleomycin IV over 10 minutes on day 1. Patients also receive etoposide IV over 1-2 hours and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
Drug: Bleomycin
Given IV
Other Names:
  • BLEO
  • BLM

Biological: Bleomycin Sulfate
Given IV
Other Names:
  • Blanoxan
  • BleMomycine
  • Blenoxane
  • Bleo-cell
  • Bleo-S
  • Bleocin
  • Bleolem
  • Bleomycin Sulfas
  • Bleomycin Sulphate
  • Bleomycini Sulfas
  • Blexane
  • Oil Bleo

Drug: Cisplatin
Given IV
Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone''s Chloride
  • Peyrone''s Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin

Drug: Etoposide
Given IV
Other Names:
  • Demethyl Epipodophyllotoxin Ethylidine Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16
  • VP 16-213
  • VP-16
  • VP-16-213
  • VP16

Drug: Etoposide Phosphate
Given IV
Other Name: Etopophos

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Pharmacogenomic Study
Correlative studies
Other Name: PHARMACOGENOMIC

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Experimental: Arm III (bleomycin, etoposide, carboplatin)
Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Drug: Bleomycin
Given IV
Other Names:
  • BLEO
  • BLM

Biological: Bleomycin Sulfate
Given IV
Other Names:
  • Blanoxan
  • BleMomycine
  • Blenoxane
  • Bleo-cell
  • Bleo-S
  • Bleocin
  • Bleolem
  • Bleomycin Sulfas
  • Bleomycin Sulphate
  • Bleomycini Sulfas
  • Blexane
  • Oil Bleo

Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carboplatinum
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo

Drug: Etoposide
Given IV
Other Names:
  • Demethyl Epipodophyllotoxin Ethylidine Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16
  • VP 16-213
  • VP-16
  • VP-16-213
  • VP16

Drug: Etoposide Phosphate
Given IV
Other Name: Etopophos

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Pharmacogenomic Study
Correlative studies
Other Name: PHARMACOGENOMIC

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Experimental: Arm IV (bleomycin, etoposide, cisplatin)
Patients receive bleomycin IV over 10 minutes on days 1, 8, and 15, etoposide IV over 1-2 hours on days 1-5, and cisplatin IV over 1-3 hours on days 1-5. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
Drug: Bleomycin
Given IV
Other Names:
  • BLEO
  • BLM

Biological: Bleomycin Sulfate
Given IV
Other Names:
  • Blanoxan
  • BleMomycine
  • Blenoxane
  • Bleo-cell
  • Bleo-S
  • Bleocin
  • Bleolem
  • Bleomycin Sulfas
  • Bleomycin Sulphate
  • Bleomycini Sulfas
  • Blexane
  • Oil Bleo

Drug: Cisplatin
Given IV
Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone''s Chloride
  • Peyrone''s Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin

Drug: Etoposide
Given IV
Other Names:
  • Demethyl Epipodophyllotoxin Ethylidine Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16
  • VP 16-213
  • VP-16
  • VP-16-213
  • VP16

Drug: Etoposide Phosphate
Given IV
Other Name: Etopophos

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Pharmacogenomic Study
Correlative studies
Other Name: PHARMACOGENOMIC

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Experimental: Low-Risk (observation)
Patients with stage I grade 2, 3 ovarian immature teratoma or low-risk stage I malignant germ cell tumors undergo observation and can transfer to standard risk arm when eligibility criteria are met.
Other: Best Practice
Undergo observation
Other Names:
  • standard of care
  • standard therapy

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Pharmacogenomic Study
Correlative studies
Other Name: PHARMACOGENOMIC

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Overall survival [ Time Frame: Two years post enrollment ]
    The time from study entry to the date of death, or date of last contact and ascertained as alive, whichever comes first.

  2. Event-free survival [ Time Frame: Two years post enrollment ]
    The time from study entry to the date of death, date of disease progression or recurrence, date of second malignant neoplasm or date of last contact and ascertained as alive, whichever comes first.


Secondary Outcome Measures :
  1. Percentage of participants with hearing loss [ Time Frame: 4 weeks after the last dose of platin therapy ]
    The hearing loss is evaluated according to the International Society of Pediatric Oncology criteria.

  2. Number of participants by understanding score category in the Adolescents and Young Adults-Hearing Screen [ Time Frame: Baseline ]
    Understanding score will be rated on a 5-point Likert scale ranging from 0 = completely incorrect to 4 = completely correct.


Other Outcome Measures:
  1. Event-free survival (EFS) for participants with and without tumor marker decline [ Time Frame: Up to 2 years ]
    Tumor marker decline is coded as yes vs no. EFS for participants with and without tumor marker decline will be reported separately.

  2. Percentage of participants with self-reported peripheral neuropathy [ Time Frame: Up to 12 months ]
    Percentage of participants with self-reported peripheral neuropathy will be reported for carboplatin group and cisplatin group separately.

  3. Percentage of participants with hearing loss [ Time Frame: Baseline ]
    Hearing loss is measured by audiometry and on the AYA-HEARS instrument.



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   up to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Low risk stratum (stage I ovarian immature teratoma and stage I malignant GCT [all sites]): Patients must be < 50 years of age at enrollment
  • Standard risk 1: Patient must be < 11 years of age at enrollment
  • Standard risk 2: Patients must be >= 11 and < 25 years of age at enrollment
  • 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 72 hours 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 =< 5% of microscopic yolk sac tumor), mixed immature and mature teratoma, (no pathological evidence of mediastinal germ cell tumor [MGCT]); tumor markers: alpha-FP =< 1,000 ng/mL, beta-HCG institutional normal; age (years) < 50
  • 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) < 50
  • 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) < 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 (pure or mixed); age (years) >= 11 and < 25
    • Site: testicular; stage: COG stage II-IV, AJCC stage II, III, International Germ Cell Consensus Classification (IGCCC) good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); 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 (pure or mixed) 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
    • 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 =< 16 years of age
  • 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 < 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
  • 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)
  • 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 < 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 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 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 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])

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03067181


  Show 488 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: A. L Frazier Children's Oncology Group

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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT03067181     History of Changes
Other Study ID Numbers: AGCT1531
NCI-2017-00178 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AGCT1531
AGCT1531 ( Other Identifier: Childrens Oncology Group )
AGCT1531 ( Other Identifier: CTEP )
U10CA180886 ( U.S. NIH Grant/Contract )
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Neoplasms, Germ Cell and Embryonal
Teratoma
Carcinoma, Embryonal
Endodermal Sinus Tumor
Choriocarcinoma
Ovarian Neoplasms
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Mesonephroma
Trophoblastic Neoplasms
Adenocarcinoma
Pregnancy Complications, Neoplastic
Pregnancy Complications
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Cisplatin
Carboplatin
Etoposide
Etoposide phosphate
Bleomycin
Antineoplastic Agents