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Surgery and Combination Chemotherapy in Treating Children With Extracranial Germ Cell Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00053352
Recruitment Status : Completed
First Posted : January 28, 2003
Results First Posted : December 8, 2017
Last Update Posted : July 13, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
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 Procedure: conventional surgery Drug: cisplatin Drug: etoposide Biological: bleomycin sulfate Other: laboratory biomarker analysis Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Study Of Reduced Therapy In The Treatment Of Children With Low And Intermediate Risk Extracranial Germ Cell Tumors
Actual Study Start Date : November 3, 2003
Actual Primary Completion Date : October 1, 2013
Actual Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I

Patients enrolled with gonadal tumors of stage II or greater or extragonadal tumors of any stage receive cisplatin IV over 90 minutes & etoposide IV over 90 minutes days 1-3 and bleomycin sulfate IV over ≥ 10 minutes day 1. Treatment repeats every 3 weeks, 3 courses (weeks 0,3 & 6).

After completion of compressed induction chemotherapy, patients with 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 abnormal tumor markers proceed to conventional surgery (second-look) and/or 3 more courses of compressed consolidation chemotherapy.

After surgery, patients with 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 induction chemotherapy in weeks 10,13, & 16.

 Procedure: conventional surgery
Other Name: surgery, conventional

Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP

Drug: etoposide
Given IV
Other Names:
  • EPEG
  • VP-16
  • VP-16-213

Biological: bleomycin sulfate
Given IV
Other Names:
  • Blenoxane
  • BLEO
  • BLM

Other: laboratory biomarker analysis
Correlative studies
No Intervention: Arm 2

Patients who are enrolled with stage I gonadal tumors receive no further anticancer therapy until evidence of tumor recurrence or the diagnosis of a second malignant neoplasm.

Observation only for recurrence or development of an SMN


Outcome Measures
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Primary Outcome Measures :
  1. Event-Free Survival (EFS) [ Time Frame: 3 Years after enrollment ]
    Proportion of patients event free at 3 years following enrollment. Event-free survival is not a primary outcome measure for Arm 2 patients.

  2. Overall Survival (OS) [ Time Frame: 3 Years after enrollment ]
    Percentage probability of being alive at 3 years following enrollment.


Secondary Outcome Measures :
  1. Days Hospitalized for Patients Who Receive Chemotherapy [ Time Frame: Up to 126 days after the start of chemotherapy ]
    Calculated to quantify the treatment cost associated with this regimen.

  2. Toxicity Associated With Chemotherapy: Grade 3 or Higher. Toxicity as Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Up to 126 days after the start of chemotherapy ]
    The number of patients assigned to receive chemotherapy that experience CTC Version 4 grade 3 or higher at any time during protocol therapy


Eligibility Criteria
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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00053352


Locations
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Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Anne Frazier, MD Children's Oncology Group
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00053352    
Other Study ID Numbers: AGCT0132
NCI-2009-00373 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000269433 ( Other Identifier: Clinical Trials.gov )
COG-AGCT0132 ( Other Identifier: Children's Oncology Group )
U10CA098543 ( U.S. NIH Grant/Contract )
First Posted: January 28, 2003    Key Record Dates
Results First Posted: December 8, 2017
Last Update Posted: July 13, 2021
Last Verified: July 2021
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Neoplasms, Germ Cell and Embryonal
Germinoma
Ovarian Neoplasms
Teratoma
Testicular Neoplasms
Carcinoma, Embryonal
Endodermal Sinus Tumor
Choriocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
 Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Genital Neoplasms, Male
Genital Diseases, Male
Male Urogenital Diseases
Testicular Diseases
Mesonephroma