Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors

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Brief Title

Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors

Official Title

High-Dose Cisplatin, Etoposide and Bleomycin (HD-PEB) Combined With Amifostine in Children With High-Risk Malignant Germ Cell Tumors - A POG Pilot Study

Brief Summary

      RATIONALE: Chemotherapy drugs use different ways to stop tumor cells from dividing so they
      stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from
      the side effects of chemotherapy.

      PURPOSE: Phase I trial to study the effectiveness of high-dose cisplatin, etoposide, and
      bleomycin plus amifostine in treating children who have malignant germ cell tumors.
    

Detailed Description

      OBJECTIVES: I. Evaluate the early efficacy and toxicity profile of high-dose cisplatin,
      etoposide, bleomycin, and amifostine in children with newly diagnosed, high-risk malignant,
      extragonadal germ cell tumors. II. Determine whether the use of amifostine can reduce the
      hematologic and nonhematologic toxic effects of this combination chemotherapy in these
      patients when compared to similar patients treated on POG-9049/CCG-8881 with the same
      combination chemotherapy. III. Determine the response rate of patients treated with this
      regimen.

      OUTLINE: Patients undergo surgical biopsy or resection. Patients then receive bleomycin IV
      over 10 minutes on day 1 and etoposide IV over 1 hour, amifostine IV over 15 minutes, and
      cisplatin IV over 1 hour on days 1-5. Treatment repeats every 3-4 weeks for 4 courses in the
      absence of unacceptable toxicity or disease progression. Patients who have no disease after 4
      courses of chemotherapy receive no further treatment. Patients who have residual disease
      undergo second-look surgery. After surgery, patients who still have active tumor receive 2
      additional courses of chemotherapy. Those patients who still have tumor after the 2
      additional courses may have a third surgery. Patients are followed every month for 6 months,
      every 2 months for 6 months, every 6 months for 1 year, and then annually thereafter until
      death.

      PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 1.39 years.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Feasibility from Efficacy Standpoint

Secondary Outcome

 Assessment of Reduction in Toxicity

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

27

Start Date

April 2000

Completion Date

September 2007

Primary Completion Date

October 2004

Eligibility Criteria

        DISEASE CHARACTERISTICS: Histologically confirmed, newly diagnosed, high-risk, extracranial
        germ cell tumors including the following: Yolk sac carcinoma (endodermal sinus tumor)
        Embryonal carcinoma Choriocarcinoma Teratoma with mixed malignant elements (malignant
        teratoma) OR Malignant recurrence (stage III or IV) of previously resected stage I
        extracranial, extragonadal tumor High-risk disease defined as stage III or IV extragonadal
        tumors Measurable disease by diagnostic imaging

        PATIENT CHARACTERISTICS: Age: Under 15 at time of diagnosis Performance status: Not
        specified Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater
        than 750/mm3 Platelet count greater than 75,000/mm3 Hepatic: Not specified Renal:
        Creatinine normal OR Glomerular filtration rate at least 50% of normal

        PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
        chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery:
        See Disease Characteristics
      

Gender

All

Ages

N/A - 14 Years

Accepts Healthy Volunteers

No

Contacts

Neyssa M. Marina, MD, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT00003811

Organization ID

9749

Secondary IDs

POG-9749

Responsible Party

Sponsor

Study Sponsor

Children's Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Neyssa M. Marina, MD, Study Chair, Stanford University


Verification Date

July 2013