Protocol Summary

Protocol No.: OCR16042

Sponsor Protocol No.: AGCT1531

Study 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

Principal Investigator(s)
Slayton, William

Objective
This partially randomized 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.

Description
Patients with low-risk stage I grade 2, 3 ovarian immature teratoma or stage I malignant germ cell tumors undergo observation and can transfer to standard risk arm when eligibility criteria are met.
Patients with standard risk 1 are randomized into 1 of 2 arms.

After completion of study treatment, patients are followed up monthly to 12 months, every 2 months to 24 months, every 6 months for years 3-5, and then annually for up to 10 years.

Phase: Phase III (Cancer Control)

Age Group: Both

Scope: National

Treatment
Arm I (bleomycin, carboplatin, etoposide)
Patients receive bleomycin and carboplatin on day 1. Patients also receive etoposide on days 1-5. Treatment repeats every 21 days for up to 4 courses.

Arm II (bleomycin, etoposide, cisplatin)
Patients receive bleomycin on day 1. Patients also receive etoposide and cisplatin on days 1-5. Treatment repeats every 21 days for up to 4 courses.

Arm III (bleomycin, etoposide, carboplatin)
Patients receive bleomycin on days 1, 8, and 15, etoposide on days 1-5, and carboplatin on day 1. Treatment repeats every 21 days for up to 3 courses.

Arm IV (bleomycin, etoposide, cisplatin)
Patients receive bleomycin on days 1, 8, and 15, etoposide on days 1-5, and cisplatin on days 1-5. Treatment repeats every 21 days for up to 3 courses.

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.

Detailed Eligibility
INCLUSION CRITERIA:
1. Up to 49 years old
2. Low risk stratum (stage I ovarian immature teratoma and stage I malignant GCT [all sites]): Patients must be 3. Standard risk 1: Patient must be 4. Standard risk 2: Patients must be >= 11 and 5. 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
6. 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, mixed immature and mature teratoma, (no pathological evidence of mediastinal germ cell tumor [MGCT]); tumor markers: alpha-FP =7. 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 and IB; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); age (years) 8. 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) 9. 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 - 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: for IGCCC good risk: alpha-FP = 11 and - 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 10. Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =11. Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) 11. 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
12. Eligibility criteria to participate in group 1 of the pilot study of the AYA-Hears instrument Note: participants in group 1 will not receive protocol-directed therapy
>= 11 and 13. Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor

** Contact study team for complete eligibility details

Applicable Disease Sites
Pediatric (Childhood) Cancer

Participating Institutions
UF Gainesville : Ashley Bayne

Contact
Ashley Bayne, RN
Phone: +1 352-294-8745

Email: abayne@ufl.edu

More Information:
View study listing on ClinicialTrials.gov
http://www.clinicaltrials.gov/ct2/show/
NCT03067181