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

Conditions

• 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 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 Seminoma 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

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Best Practice — OTHER
  Undergo observation
• Biopsy Procedure — PROCEDURE
  Undergo a tumor biopsy
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Bleomycin Sulfate — BIOLOGICAL
  Given IV
• Carboplatin — DRUG
  Given IV
• Cisplatin — DRUG
  Given IV
• Computed Tomography — PROCEDURE
  Undergo a CT scan
• Etoposide — DRUG
  Given IV
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Pulmonary Function Test — PROCEDURE
  Undergo a pulmonary function test
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Chemotherapy drugs, 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. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors.

Key Dates

Start date

May 25, 2017

Status verified

Apr 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

1,780 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
• 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. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
• 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. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
• 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. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial. Patients undergo a pulmonary function test on study.
• Experimental: Low-Risk (observation)
  Patients with low-risk stage I grade 2, 3 ovarian immature teratoma or stage I non-seminoma or seminoma MGCTs undergo observation and can transfer to standard risk arm when eligibility criteria are met. Patients with stage I seminoma testicular MGCT undergo observation, and those with residual/recurrent disease are treated at the discretion of their physician. Patients undergo CT, MRI, and/or chest x-ray as well as blood sample collection throughout the trial. Patients may also undergo a tumor biopsy throughout the trial.

Primary Outcome Measure

Overall survival [ Time Frame: Two years post enrollment ]

Locations (566)

Find similar trials in Birmingham, AL

Related Studies

• Germ Cell Tumor and Testicular Tumor DNA Registry
  Recruiting · Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey
• Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours
  PHASE3 · Recruiting · University of Sydney · New York, New York
• Study of B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma/Diffuse Midline Glioma and Recurrent or Refractory Pediatric Central Nervous System Tumors
  PHASE1 · Recruiting · Seattle Children's Hospital · Seattle, Washington
• Vorinostat in Combination With Chemotherapy in Relapsed/Refractory Solid Tumors and CNS Malignancies
  PHASE1 · Recruiting · New York Medical College · Valhalla, New York