Study Summary
This trial is testing how well active surveillance, bleomycin, etoposide, carboplatin or cisplatin work in treating pediatric and adult patients with germ cell tumors.
Eligible Conditions
- Germ Cell Tumors
- Stage I Ovarian Teratoma
- Extragonadal Embryonal Carcinoma
- Malignant Germ Cell Tumor
- Stage I Ovarian Choriocarcinoma
- Stage I Ovarian Embryonal Carcinoma
- Stage II Ovarian Yolk Sac Tumor
- Stage III Ovarian Choriocarcinoma
- Stage II Ovarian Embryonal Carcinoma
- Stage II Testicular Embryonal Carcinoma
- Stage III Ovarian Embryonal Carcinoma
- Stage I Testicular Yolk Sac Tumor
- Stage II Testicular Choriocarcinoma
- Stage III Testicular Choriocarcinoma
- Stage III Testicular Yolk Sac Tumor
- Stage IV Ovarian Embryonal Carcinoma
- Testicular Mixed Choriocarcinoma and Embryonal Carcinoma
- Testicular Mixed Germ Cell Tumor
- Childhood Extracranial Germ Cell Tumor
- Stage II Testicular Yolk Sac Tumor
- Stage III Ovarian Yolk Sac Tumor
- Stage II Ovarian Choriocarcinoma
- Stage IV Ovarian Choriocarcinoma
- Stage IV Ovarian Yolk Sac Tumor
- Malignant Ovarian Teratoma
- Stage I Testicular Choriocarcinoma
- Stage I Testicular Seminoma
- Stage III Testicular Embryonal Carcinoma
- Stage I Ovarian Yolk Sac Tumor
- Stage I Testicular Embryonal Carcinoma
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
2 Primary · 2 Secondary · Reporting Duration: Two years post enrollment
Week 8
Proportion of participants with hearing loss
Baseline
Number of participants by understanding score category in the Adolescents and Young Adults-Hearing Screen
Percentage of participants with hearing loss
Two years post enrollment
Event-free survival
Overall survival
Up to 12 months
Mean self-reported peripheral neuropathy score
Percentage of participants with self-reported peripheral neuropathy
Up to 2 years
Event-free survival (EFS) for participants with and without tumor marker decline
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
Gemcitabine Plus Cisplatin (GC)
51%Neutropenia
47%Leukopenia
46%Nausea
43%Vomiting
35%Anaemia
31%Decreased appetite
26%Haemoglobin decreased
26%Fatigue
25%Constipation
25%White blood cell count decreased
24%Neutrophil count decreased
19%Alanine aminotransferase increased
13%Platelet count decreased
12%Rash
10%Thrombocytopenia
10%Aspartate aminotransferase increased
9%Blood sodium decreased
8%Hypokalaemia
7%Pyrexia
7%Insomnia
6%Hyponatraemia
6%Cough
6%Blood creatinine increased
6%Lymphopenia
6%Diarrhoea
6%Dyspepsia
6%Red blood cell count decreased
4%Dizziness
2%Bone marrow failure
1%Cerebral infarction
1%Superior vena cava syndrome
1%Embolism venous
1%Pulmonary embolism
1%Dyspnoea
1%Ischaemic stroke
Trial Design
5 Treatment Groups
Arm IV (bleomycin, etoposide, cisplatin)
1 of 5
Arm II (bleomycin, etoposide, cisplatin)
1 of 5
Arm I (bleomycin, carboplatin, etoposide)
1 of 5
Arm III (bleomycin, etoposide, carboplatin)
1 of 5
Low-Risk (observation)
1 of 5
Experimental Treatment
2059 Total Participants · 5 Treatment Groups
Primary Treatment: Cisplatin · No Placebo Group · Phase 3
Arm IV (bleomycin, etoposide, cisplatin)Experimental Group · 14 Interventions: Pulmonary Function Test, Computed Tomography, Pharmacogenomic Study, Quality-of-Life Assessment, Biopsy, Magnetic Resonance Imaging, Cisplatin, Biospecimen Collection, Bleomycin, Bleomycin Sulfate, Etoposide Phosphate, Etoposide, Laboratory Biomarker Analysis, Questionnaire Administration · Intervention Types: Procedure, Procedure, Other, Other, Procedure, Procedure, Drug, Procedure, Drug, Biological, Drug, Drug, Other, Other
Arm II (bleomycin, etoposide, cisplatin)Experimental Group · 14 Interventions: Pulmonary Function Test, Computed Tomography, Pharmacogenomic Study, Quality-of-Life Assessment, Biopsy, Magnetic Resonance Imaging, Cisplatin, Biospecimen Collection, Bleomycin, Bleomycin Sulfate, Etoposide Phosphate, Etoposide, Laboratory Biomarker Analysis, Questionnaire Administration · Intervention Types: Procedure, Procedure, Other, Other, Procedure, Procedure, Drug, Procedure, Drug, Biological, Drug, Drug, Other, Other
Arm I (bleomycin, carboplatin, etoposide)Experimental Group · 14 Interventions: Pulmonary Function Test, Computed Tomography, Pharmacogenomic Study, Quality-of-Life Assessment, Carboplatin, Biopsy, Magnetic Resonance Imaging, Biospecimen Collection, Bleomycin, Bleomycin Sulfate, Etoposide Phosphate, Etoposide, Laboratory Biomarker Analysis, Questionnaire Administration · Intervention Types: Procedure, Procedure, Other, Other, Drug, Procedure, Procedure, Procedure, Drug, Biological, Drug, Drug, Other, Other
Arm III (bleomycin, etoposide, carboplatin)Experimental Group · 14 Interventions: Pulmonary Function Test, Computed Tomography, Pharmacogenomic Study, Quality-of-Life Assessment, Carboplatin, Biopsy, Magnetic Resonance Imaging, Biospecimen Collection, Bleomycin, Bleomycin Sulfate, Etoposide Phosphate, Etoposide, Laboratory Biomarker Analysis, Questionnaire Administration · Intervention Types: Procedure, Procedure, Other, Other, Drug, Procedure, Procedure, Procedure, Drug, Biological, Drug, Drug, Other, Other
Low-Risk (observation)Experimental Group · 9 Interventions: Computed Tomography, Pharmacogenomic Study, Quality-of-Life Assessment, Biopsy, Magnetic Resonance Imaging, Biospecimen Collection, Laboratory Biomarker Analysis, Questionnaire Administration, Best Practice · Intervention Types: Procedure, Other, Other, Procedure, Procedure, Procedure, Other, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pulmonary Function Test
2014
Completed Early Phase 1
~570
Computed Tomography
2017
Completed Phase 2
~3410
Carboplatin
FDA approved
Biopsy
2014
Completed Phase 4
~1120
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Platinum
Not yet FDA approved
Biospecimen Collection
2004
Completed Phase 1
~670
Bleomycin
FDA approved
Bleomycin
FDA approved
Etoposide
FDA approved
Beta-D-Glucose
Not yet FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: two years post enrollment
Who is running the clinical trial?
Children's Oncology GroupLead Sponsor
451 Previous Clinical Trials
235,012 Total Patients Enrolled
3 Trials studying Germ Cell Tumors
1,864 Patients Enrolled for Germ Cell Tumors
National Cancer Institute (NCI)NIH
13,161 Previous Clinical Trials
41,165,324 Total Patients Enrolled
6 Trials studying Germ Cell Tumors
1,759 Patients Enrolled for Germ Cell Tumors
A. L FrazierPrincipal InvestigatorChildren's Oncology Group
Eligibility Criteria
Age Any Age · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The patient has a moderate level of risk for the condition being studied (SR2).
There is no age limit for patients with stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT (all sites) considered to be at low risk.
You have a low-risk stage I non-seminoma germ cell tumor that is located in the ovary, testicle, or other parts of the body. The tumor must contain at least one of the following types of cells: yolk sac tumor, embryonal carcinoma, or choriocarcinoma. There are no age restrictions.
You have a certain type of cancer (ovarian, testicular, or extragonadal) that is in a certain stage and contains at least one of the following types of cells: yolk sac tumor, embryonal carcinoma, or choriocarcinoma. You are also younger than 11 years old.
Who else is applying?
What state do they live in?
| Florida | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Saint Joseph's Hospital/Children's Hospital-Tampa | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
Frequently Asked Questions
What is the mortality rate for patients who take Cisplatin?
"Cisplatin has undergone multiple rounds of testing, so it is considered safe and received a score of 3." - Anonymous Online Contributor
Unverified Answer
Are there other ongoing investigations that use Cisplatin?
"City of Hope Comprehensive Cancer Center first began studying cisplatin in 1997. In the intervening years, there have been 2751 completed studies and 1377 active ones. Henderson, Texas is a hotspot for this sort of research." - Anonymous Online Contributor
Unverified Answer
Are there other hospitals or research centers participating in this trial in Canada?
"Currently, this study is looking for participants at 100 clinical sites. Some of these locations are in Henderson, Houston, and Hartford. If you enroll in the study, the research team will try to place you at a site close to your home to reduce travel." - Anonymous Online Contributor
Unverified Answer
For what purpose is Cisplatin most often prescribed?
"Cisplatin is often the go-to medication for treating malignant pleural mesothelioma. That being said, Cisplatin has also shown clinical efficacy when treating other conditions such as advanced head and neck cancer, advance directives, and sarcoma." - Anonymous Online Contributor
Unverified Answer
To date, how many research subjects have enrolled in this experiment?
"That is correct, this research is currently looking for participants. The study was originally published on May 8th, 2017 and was last edited on October 19th, 2022. They are aiming to enroll 2059 patients from 100 different locations." - Anonymous Online Contributor
Unverified Answer