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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

No Placebo-Only Group

Pivotal Trial

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event-free survival

Overall survival

Secondary study objectives

Number of participants by understanding score category in the Adolescents and Young Adults-Hearing Screen

Proportion of participants with hearing loss

Other study objectives

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

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Dyspnoea

Cerebral infarction

Ischaemic stroke

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Cisplatin

2013

Completed Phase 3

~3120

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160