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Chemotherapy for Cancer

Phase 3
Recruiting
Led By A. L Frazier
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Standard risk 2: Patients must be >= 11 and < 25 years of age at enrollment
Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor
Must not have
Patients must have had no prior systemic therapy for the current cancer diagnosis
Patients with significant, pre-existing co-morbid respiratory disease that contraindicate the use of bleomycin are ineligible for the standard risk arms of the trial
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years post enrollment
Awards & highlights

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.

Who is the study for?
This trial is for pediatric and adult patients with various types of germ cell tumors, including those in the ovaries or testes. It's open to all ages for certain low-risk conditions but has specific age criteria for standard risk groups. Participants must have adequate organ function and no prior treatments for their current cancer diagnosis.Check my eligibility
What is being tested?
The study monitors low-risk germ cell tumor recurrence post-surgery and compares chemotherapy drugs (bleomycin, carboplatin, etoposide, cisplatin) in treating metastatic standard risk tumors. It includes imaging tests like MRI and CT scans, pulmonary tests, quality-of-life assessments, biopsies, and genetic studies.See study design
What are the potential side effects?
Chemotherapy may cause side effects such as nausea, vomiting, hair loss, fatigue, increased infection risk due to lowered blood counts; bleomycin can affect lungs causing breathing issues; kidney function might be impacted by cisplatin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 11 and 25 years old.
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I have had chemotherapy with cisplatin or carboplatin for cancer.
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I have been newly diagnosed with a stage I germ cell tumor.
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I am younger than 11 years old.
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I am aged 11-24 with a specific type of advanced testicular cancer and certain tumor markers.
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I am aged 11-24 with a specific type of cancer not originating in the gonads.
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I can care for myself but may not be able to do active work or play.
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My bilirubin levels are within the normal range for my age.
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I have a low-risk, stage I ovarian immature teratoma with specific tumor markers.
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I have a low-risk stage I germ cell tumor in the ovary, testicle, or another area.
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I am under 11 with a specific type of ovarian, testicular, or extragonadal cancer.
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I am aged 11-24 with a specific type of ovarian cancer at a certain stage.
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I am between 11 and 24 years old.
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My liver tests are within normal limits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not received any systemic therapy for my current cancer.
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I do not have severe lung problems that prevent me from taking bleomycin.
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My cancer diagnosis is not listed among the specific types or stages mentioned.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event-free survival
Overall survival
Secondary outcome measures
Number of participants by understanding score category in the Adolescents and Young Adults-Hearing Screen
Proportion of participants with hearing loss
Other outcome measures
Event-free survival (EFS) for participants with and without tumor marker decline
Mean self-reported peripheral neuropathy score

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680
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%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Cerebral infarction
1%
Dyspnoea
1%
Ischaemic stroke
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)

Trial Design

5Treatment groups
Experimental Treatment
Group I: Low-Risk (observation)Experimental Treatment8 Interventions
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.
Group II: Arm IV (bleomycin, etoposide, cisplatin)Experimental Treatment11 Interventions
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.
Group III: Arm III (bleomycin, etoposide, carboplatin)Experimental Treatment11 Interventions
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.
Group IV: Arm II (bleomycin, etoposide, cisplatin)Experimental Treatment11 Interventions
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.
Group V: Arm I (bleomycin, carboplatin, etoposide)Experimental Treatment11 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bleomycin Sulfate
2010
Completed Phase 3
~1960
Cisplatin
2013
Completed Phase 3
~1940
Computed Tomography
2017
Completed Phase 2
~2720
Etoposide
2010
Completed Phase 3
~2440
Pulmonary Function Test
2023
Completed Early Phase 1
~600
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Carboplatin
2014
Completed Phase 3
~6670
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1720

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
456 Previous Clinical Trials
237,690 Total Patients Enrolled
3 Trials studying Germ Cell Tumors
1,864 Patients Enrolled for Germ Cell Tumors
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,957,304 Total Patients Enrolled
6 Trials studying Germ Cell Tumors
1,743 Patients Enrolled for Germ Cell Tumors
A. L FrazierPrincipal InvestigatorChildren's Oncology Group

Media Library

Active Surveillance Clinical Trial Eligibility Overview. Trial Name: NCT03067181 — Phase 3
Germ Cell Tumors Research Study Groups: Low-Risk (observation), Arm IV (bleomycin, etoposide, cisplatin), Arm III (bleomycin, etoposide, carboplatin), Arm I (bleomycin, carboplatin, etoposide), Arm II (bleomycin, etoposide, cisplatin)
Germ Cell Tumors Clinical Trial 2023: Active Surveillance Highlights & Side Effects. Trial Name: NCT03067181 — Phase 3
Active Surveillance 2023 Treatment Timeline for Medical Study. Trial Name: NCT03067181 — Phase 3
~607 spots leftby Jun 2027
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