Etoposide, Carboplatin, and Bleomycin in Treating Young Patients Undergoing Surgery For Malignant Germ Cell Tumors

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Brief Title

Etoposide, Carboplatin, and Bleomycin in Treating Young Patients Undergoing Surgery For Malignant Germ Cell Tumors

Official Title

Germ Cell Tumour Study II

Brief Summary

      RATIONALE: Drugs used in chemotherapy, such as etoposide, carboplatin, and bleomycin, 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 chemotherapy drugs before surgery may make the tumor smaller and reduce the
      amount of normal tissue that needs to be removed. Giving combination chemotherapy after
      surgery may kill any tumor cells that remain.

      PURPOSE: This clinical trial is studying how well giving etoposide, carboplatin, and
      bleomycin works in treating young patients undergoing surgery for malignant germ cell tumors.
    

Detailed Description

      OBJECTIVES:

        -  Determine the toxic effects of etoposide, carboplatin, and bleomycin in young patients
           with malignant germ cell tumors.

      OUTLINE: Patients are assigned to one of two treatment arms based on their tumor type
      (testicular vs ovarian, uterine, vaginal, sacrococcygeal, retroperitoneal, or thoracic).

        -  Group 1 (testicular tumors): Patients undergo radical orchiectomy. Patients with stage I
           tumors and alpha-fetoprotein (AFP) decreasing at the expected rate receive no further
           treatment unless there is a subsequent rise in the AFP or a clinical recurrence.
           Patients with stage II-IV tumors receive etoposide IV over 1 hour on days 1-3,
           carboplatin IV over 1 hour on day 2, and bleomycin IV over 15 minutes on day 3.
           Treatment repeats every 21- 28 days for at least 4 courses in the absence of disease
           progression or unacceptable toxicity. Residual teratoma may be removed, if indicated,
           after completion of chemotherapy.

        -  Group 2 (ovarian, uterine, vaginal, sacrococcygeal, retroperitoneal, or thoracic germ
           cell tumors): Patients undergo surgical removal or biopsy of the tumor. Patients then
           receive etoposide, carboplatin, and bleomycin as above. Patients may then undergo
           further surgery at the discretion of the principal investigator.

      After completion of study treatment, patients are followed periodically.

      PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
    


Study Type

Interventional




Condition

Brain and Central Nervous System Tumors

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

100

Start Date

April 1989



Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically proven malignant germ cell tumors at all stages

               -  Testicular tumors

                    -  Stage I - Confined to testes

                    -  Stage II - Confined to testes and retroperitoneal/abdominal lymph nodes

                    -  Stage III - Supradiaphragmatic nodal disease (mediastinal and/or
                       supraclavicular)

                    -  Stage IV - Extralymphatic spread (liver, lung, bone, brain, skin, etc.)

               -  Ovarian, uterine, vaginal, and sacrococcygeal tumors

                    -  Stage I - Confined to ovary/uterus/vagina/pre- and postsacral area

                    -  Stage II - Spread limited to the pelvis

                    -  Stage III - Spread limited to the abdomen (excluding liver)

                    -  Stage IV - Spread to liver or beyond the abdominal cavity

               -  Abdominal, retroperitoneal, and thoracic primary tumors

                    -  Stage I - Confined to site of origin and resectable

                    -  Stage II - Local spread

                    -  Stage III - Extensive spread confined to one side of the diaphragm
                       (excluding the liver)

                    -  Stage IV - Tumor spread to the liver, to both sides of the diaphragm, and/or
                       to bones, bone marrow, brain, etc.

               -  Intracranial germ cell tumor cases allowed even if an alternative protocol is
                  being followed

        PATIENT CHARACTERISTICS:

          -  Not specified

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy
      

Gender

All

Ages

N/A - 15 Years

Accepts Healthy Volunteers

No

Contacts

A. Oakhill, MD, , 

Location Countries

Ireland

Location Countries

Ireland

Administrative Informations


NCT ID

NCT00276718

Organization ID

CDR0000454749

Secondary IDs

CCLG-GC-1989-01


Study Sponsor

Children's Cancer and Leukaemia Group


Study Sponsor

A. Oakhill, MD, Study Chair, Bristol Royal Hospital for Children


Verification Date

February 2006