Overview

This trial is active, not recruiting.

Conditions childhood embryonal tumor, childhood extracranial germ cell tumor, childhood extragonadal germ cell tumor, childhood malignant ovarian germ cell tumor, childhood malignant testicular germ cell tumor, childhood teratoma, ovarian embryonal carcinoma, ovarian yolk sac tumor, stage ii malignant testicular germ cell tumor, stage iia ovarian germ cell tumor, stage iib ovarian germ cell tumor, stage iic ovarian germ cell tumor, stage iii malignant testicular germ cell tumor, stage iiia ovarian germ cell tumor, stage iiib ovarian germ cell tumor, stage iiic ovarian germ cell tumor, testicular choriocarcinoma and yolk sac tumor, testicular embryonal carcinoma
Treatments conventional surgery, cisplatin, etoposide, bleomycin sulfate, laboratory biomarker analysis
Phase phase 3
Sponsor Children's Oncology Group
Collaborator National Cancer Institute (NCI)
Start date November 2003
End date October 2013
Trial size 302 participants
Trial identifier NCT00053352, AGCT0132, CDR0000269433, COG-AGCT0132, NCI-2009-00373, U10CA098543

Summary

This phase III trial is studying surgery followed by combination chemotherapy to see how well it works in treating children with germ cell tumors that are not located in the head. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them after surgery, may kill any remaining tumor cells following surgery. It is not yet known whether combination chemotherapy is effective in decreasing the recurrence of childhood germ cell tumors.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients receive cisplatin IV over 90 minutes and etoposide IV over 90 minutes on days 1-3 and bleomycin sulfate IV over ≥ 10 minutes on day 1. Treatment repeats every 3 weeks for 3 courses (weeks 0,3, & 6). After completion of compressed induction chemotherapy, patients who have no change in disease status or disease progression are removed from study. Patients with no evidence of disease receive no further therapy. Patients with a partial response or who have abnormal tumor markers proceed to conventional surgery (second-look) and/or 3 more courses of compressed consolidation chemotherapy. Patients undergo surgical resection of residual tumor. After surgery, patients who are in pathologic complete response and have normal tumor markers receive no further therapy. Patients who remain with a partial response after surgery receive compressed consolidation chemotherapy. Patients receive cisplatin, etoposide, and bleomycin as in induction chemotherapy in weeks 10,13, & 16.
conventional surgery surgery, conventional
cisplatin CACP
Given IV
etoposide EPEG
Given IV
bleomycin sulfate Blenoxane
Given IV
laboratory biomarker analysis
Correlative studies

Primary Outcomes

Measure
Event-free survival (EFS) of at least 92% (for intermediate-risk tumors only) defined as the first occurrence of relapse, progressive disease, second malignancy, or death after the start of protocol-specified chemotherapy
time frame: Assessed up to 3 years
Overall survival (OS) of at least 95% (both low-risk and intermediate-risk tumors)
time frame: Assessed up to 4 years
Days of hospitalization and number of doctor visits
time frame: During treatment
Toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
time frame: During and after completion of study treatment

Eligibility Criteria

Male or female participants up to 21 years old.

Inclusion Criteria: - Extracranial germ cell tumor that contains 1 of the following malignant histologies: NOTE: Mixed germ cell tumors that include mature/immature teratoma are eligible provided 1 of the 3 histologies listed above is also present in the tumor. - Yolk sac tumor - Embryonal carcinoma - Choriocarcinoma - Low-risk disease (closed to accrual as of 01/20/10) - Stage I gonadal tumors (ovarian and testicular) - Must have undergone complete surgical and radiologic staging to exclude the possibility of > stage I disease - Intermediate-risk disease - Stage II, III, or IV malignant testicular GCT - Stage II or III malignant ovarian GCT - Stage I or II malignant extragonadal GCT - Previously stage I gonadal patients who have relapsed on the low-risk (observation) stratum of this study(closed to accrual as of 01/20/10) - Patients with immature teratoma or mature teratoma who relapse with a malignant component - No patients with any of the following diagnoses: - Stage IV ovarian and stage III-IV extragonadal GCT - Intracranial GCT - Pure mature or immature teratoma, pure dysgerminoma, or seminoma - Patients with a non-germ cell component in their GCT (e.g., primitive neuroectodermal tumors or rhabdomyosarcoma) - Alpha-fetoprotein and beta human chorionic gonadotropin tumor markers known - If > 5 days have elapsed from the time of obtaining original markers, tumor markers must be repeated before enrollment of low-risk patients and before initiating therapy in intermediate-risk patients (the results of the repeated tumor markers do not have to be known at the time of study enrollment) - Must be enrolled within 6 weeks of original diagnostic surgery - Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR a serum creatinine based on age/gender as follows: - ≤ 0.4 mg/dL (for patients 1 to 5 months of age) - ≤ 0.5 mg/dL (for patients 6 to 11 months of age) - ≤ 0.6 mg/dL (for patients 1 year of age) - ≤ 0.8 mg/dL (for patients 2 to 5 years of age) - ≤ 1.0 mg/dL (for patients 6 to 9 years of age) - ≤ 1.2 mg/dL (for patients 10 to 12 years of age) - ≤ 1.4 mg/dL (for female patients ≥ 13 years of age) - ≤ 1.5 mg/dL (for male patients 13 to 15 years of age) - ≤ 1.7 mg/dL (for male patients ≥ 16 years of age) - No prior chemotherapy - No prior radiotherapy

Additional Information

Official title A Phase III Study Of Reduced Therapy In The Treatment Of Children With Low And Intermediate Risk Extracranial Germ Cell Tumors
Principal investigator Anne Frazier, MD
Description OBJECTIVES: I. Determine whether children with newly diagnosed low- or intermediate-risk extracranial germ cell tumors (GCTs) can maintain a 3-year event-free survival of at least 92% (for intermediate-risk tumors only) and overall survival of at least 95% (both low-risk and intermediate-risk tumors) after treatment with surgery followed by compressed cisplatin, etoposide, and bleomycin (low-risk disease closed to accrual as of 01/20/10). II. Determine the percentage of patients with stage I ovarian or stage I testicular GCTs for whom chemotherapy can be eliminated. III. Determine the percentage of intermediate-risk patients who require only 3 courses of therapy. IV. Determine the acute toxic effects of compressed therapy in these patients. V. Determine the long-term sequelae in patients treated with this regimen. VI. Determine the number of hospital days and total drug doses required for patients treated with compressed therapy. VII. Compare the number of protocol-directed treatment days used in CCG-8882 vs the number of treatment days used in this study. VIII. Determine the cytogenetic and molecular genetic features in patients treated with this regimen. OUTLINE: Patients are stratified according to disease risk (low vs intermediate). SURGERY: Patients undergo surgical resection. Low-risk disease: Patients with gonadal primaries and no evidence of disease after surgery undergo monitoring for disease progression. Patients who remain disease free receive no further treatment. Patients who have disease progression after surgery receive compressed induction chemotherapy. (closed to accrual as of 01/20/2010) Intermediate-risk disease: After surgery, patients proceed to compressed induction chemotherapy. COMPRESSED INDUCTION CHEMOTHERAPY: Patients receive cisplatin IV over 90 minutes and etoposide IV over 90 minutes on days 1-3 and bleomycin IV over ≥ 10 minutes on day 1. Treatment repeats every 3 weeks for 3 courses (weeks 0, 3, and 6). After completion of compressed induction chemotherapy, patients who have no change in disease status or disease progression are removed from study. Patients with no evidence of disease receive no further therapy. Patients with a partial response or who have abnormal tumor markers proceed to second-look surgery and/or 3 more courses of compressed consolidation chemotherapy. SECOND-LOOK SURGERY: Patients undergo surgical resection of residual tumor. After surgery, patients who are in pathologic complete response and have normal tumor markers receive no further therapy. Patients who remain with a partial response after surgery receive compressed consolidation chemotherapy. COMPRESSED CONSOLIDATION CHEMOTHERAPY: Patients receive cisplatin, etoposide, and bleomycin as in induction chemotherapy in weeks 10, 13, and 16. Patients are followed up monthly for 6 months, every 3 months for 18 months, and then annually for up to 10 years.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Children's Oncology Group.