Observation and/or Combination Chemotherapy After Surgery or Biopsy in Treating Young Patients With Extracranial Germ Cell Tumors

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Brief Title

Observation and/or Combination Chemotherapy After Surgery or Biopsy in Treating Young Patients With Extracranial Germ Cell Tumors

Official Title

Protocol for the Treatment of Extracranial Germ Cell Tumours in Children and Adolescents (GC III)

Brief Summary

      RATIONALE: Sometimes, after surgery, the tumor may not need additional treatment until it
      progresses. In this case, observation may be sufficient. Drugs used in chemotherapy work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor
      cells. Giving combination chemotherapy after surgery may kill any remaining tumor cells.

      PURPOSE: This phase III trial is studying how well observation and/or combination
      chemotherapy works after surgery or biopsy in treating young patients with extracranial germ
      cell tumors.
    

Detailed Description

      OBJECTIVES:

        -  Stratify and reduce treatment for pediatric patients with extracranial germ cell tumors
           while maintaining event-free survival.

        -  Treat newly diagnosed patients with extracranial germ cell tumors requiring chemotherapy
           with a carboplatin-based strategy.

        -  Develop a common strategy for the treatment of patients with recurrent or progressive
           extracranial germ cell tumors.

        -  Register all cases of mature and immature teratoma.

        -  Develop a common strategy for the management of immature and mature teratoma, including
           follow-up strategies to permit early detection of yolk sac recurrence.

      OUTLINE: This is a multicenter study.

      Patients who have not had prior biopsy or surgical resection undergo biopsy (if feasible) or
      surgical resection. Patients with mature or immature teratoma undergo observation. These
      patients who relapse (i.e., tumor regrowth) may undergo further surgical resection unless
      tumor markers are significantly elevated. If the tumor markers are significantly elevated,
      these patients proceed to JEB chemotherapy according to risk group. Patients with all other
      malignant germ cell tumors are assigned to 1 of 3 treatment groups according to risk.

        -  Low-risk group: Patients with normal tumor markers undergo observation. Patients with
           rising tumor markers only AND no imageable tumor proceed to treatment as in the
           intermediate-risk group. Patients with rising tumor markers AND/OR imageable tumor are
           considered to have relapsed and proceed to treatment as in the intermediate- or
           high-risk group.

        -  Intermediate-risk group: Patients receive JEB chemotherapy comprising etoposide IV over
           4 hours on days 1-3, carboplatin IV over 1 hour on day 2, and bleomycin IV over 30
           minutes on day 3. Treatment repeats every 21 days for 4 courses. Patients with residual
           tumors after completion of chemotherapy may undergo second-look surgery.

        -  High-risk group: Patients receive JEB chemotherapy as in the intermediate-risk group for
           6 courses. Patients with residual tumors after completion of chemotherapy may undergo
           second-look surgery.

        -  Relapse therapy: Patients in the intermediate- or high-risk group who relapse after
           completion of JEB chemotherapy receive vinblastine IV on days 1 and 2, ifosfamide IV
           over 1 hour on days 1-5, and cisplatin IV on days 1-5. Treatment repeats every 21 days
           for 6 courses.

      PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Event-free survival


Condition

Childhood Germ Cell Tumor

Intervention

bleomycin sulfate


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

105

Start Date

May 2005


Primary Completion Date

May 2010

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically* proven extracranial malignant germ cell tumor (GCT), including
             mature/immature teratoma, with or without elevated alpha-fetoprotein (AFP) or human
             chorionic gonadotropin (HCG) levels

               -  Newly diagnosed disease

               -  Patients with relapsed or progressive extracranial malignant GCT allowed if
                  previously treated with carboplatin, etoposide, and bleomycin (JEB) chemotherapy

                    -  Patients relapsing following JEB are eligible for the study relapse strategy
                       NOTE: *Patients with unequivocally raised AFP/HCG whose risk of biopsy is
                       felt to be high can be diagnosed by clinical grounds, imaging, and markers

          -  No intracranial GCTs

        PATIENT CHARACTERISTICS:

          -  Neutrophil count ≥ 1,000/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Bilirubin ≤ 2 times upper limit of normal (ULN)

          -  ALT ≤ 3 times ULN

          -  Not pregnant or nursing

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior chemotherapy other than JEB
      

Gender

All

Ages

N/A - 17 Years

Accepts Healthy Volunteers

No

Contacts

Juliet Hale, MD, , 

Location Countries

Ireland

Location Countries

Ireland

Administrative Informations


NCT ID

NCT00274950

Organization ID

CDR0000454553

Secondary IDs

CCLG-GC-2005-04


Study Sponsor

Children's Cancer and Leukaemia Group


Study Sponsor

Juliet Hale, MD, Principal Investigator, Sir James Spence Institute of Child Health at Royal Victoria Infirmary


Verification Date

June 2009