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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00053352
First received: January 27, 2003
Last updated: February 28, 2014
Last verified: February 2014
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    A piecewise exponential failure rate model for the theoretical EFS time for both the low and intermediate risk patients will be used.

  • Overall survival (OS) of at least 95% (both low-risk and intermediate-risk tumors) [ Time Frame: Assessed up to 4 years ] [ Designated as safety issue: No ]
    The model for OS will also be derived from a piecewise exponential failure rate model. The distribution of the complementary log-log transformation of the Kaplan-Meier estimate of the four-year survival will be used to calculate a 95% confidence interval for the true death rate.

  • Days of hospitalization and number of doctor visits [ Time Frame: During treatment ] [ Designated as safety issue: No ]
    Calculated to quantify the treatment cost associated with this regimen.

  • Toxicity as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: During and after completion of study treatment ] [ Designated as safety issue: No ]
    The descriptions and grading scales found in the revised National Cancer Institute CTCAE v 4 will be used.


Enrollment: 302
Study Start Date: November 2003
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I

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.

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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053352

  Show 126 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Anne Frazier, MD Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00053352     History of Changes
Other Study ID Numbers: AGCT0132, NCI-2009-00373, CDR0000269433, COG-AGCT0132, U10CA098543
Study First Received: January 27, 2003
Last Updated: February 28, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Choriocarcinoma
Endodermal Sinus Tumor
Neoplasms, Germ Cell and Embryonal
Teratoma
Testicular Neoplasms
Carcinoma, Embryonal
Germinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Trophoblastic Neoplasms
Gestational Trophoblastic Disease
Adenocarcinoma
Pregnancy Complications, Neoplastic
Pregnancy Complications
Mesonephroma
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female

ClinicalTrials.gov processed this record on August 20, 2014