Combination Chemotherapy in Treating Children With Newly Diagnosed Malignant Germ Cell Tumors

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Brief Title

Combination Chemotherapy in Treating Children With Newly Diagnosed Malignant Germ Cell Tumors

Official Title

Pilot Study of Cisplatin, Etoposide, Bleomycin and Escalating Dose Cyclophosphamide Therapy for Children With High Risk Malignant Germ Cell Tumors

Brief Summary

      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase I trial to study the effect on the body of combining cyclophosphamide with
      cisplatin, etoposide, and bleomycin in treating children who have newly diagnosed malignant
      germ cell tumors that are not in the brain and gonads.
    

Detailed Description

      OBJECTIVES:

        -  Determine the maximum tolerated dose and toxicity profile of cyclophosphamide in
           combination with bleomycin, etoposide, and cisplatin in pediatric patients with newly
           diagnosed high-risk extracranial, extragonadal malignant germ cell tumors.

        -  Determine the response rate in patients treated with this regimen.

      OUTLINE: This is a pilot, multicenter, dose-escalation study of cyclophosphamide.

        -  Induction therapy: Patients receive bleomycin IV over 10-20 minutes on day 1, etoposide
           IV over 1 hour and cisplatin IV over 4 hours on days 1-5, and cyclophosphamide IV over 1
           hour on day 1. Patients also receive filgrastim (G-CSF) subcutaneously once daily
           beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21
           days for 4 courses in the absence of disease progression or unacceptable toxicity.

      Cohorts of 6 patients receive escalating doses of cyclophosphamide until the maximum
      tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
      of 6 patients experience dose-limiting toxicity.

      Patients are evaluated after 4 courses of therapy. Patients with partial response or stable
      disease undergo second-look surgery, receive 2 more courses of induction therapy, and are
      then re-evaluated. Patients who do not achieve complete response (CR) after a total of 6
      courses may undergo a third surgery. Patients who still have tumor that cannot be removed are
      removed from study therapy. Patients who achieve a CR at anytime are followed.

      Patients are followed monthly for 1 year, every 6 months for 1 year, and then annually for 3
      years.

      PROJECTED ACCRUAL: A total of 6-18 patients will be accrued for this study within 1.3 years.
    


Study Type

Interventional


Primary Outcome

Feasibility of adding cyclophosphamide to a PEB backbone

Secondary Outcome

 Maximum tolerated dose

Condition

Childhood Germ Cell Tumor

Intervention

bleomycin sulfate

Study Arms / Comparison Groups

 combination chemotherapy
Description:  Induction therapy: bleomycin sulfate IV over 10-20 minutes on day 1, etoposide IV over 1 hour and cisplatin IV over 4 hours on days 1-5, and cyclophosphamide IV over 1 hour on day 1. MESNA & Filgrastim (G-CSF) subcutaneously once daily beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. 6 patients receive escalating doses of cyclophosphamide until the maximum tolerated dose (MTD) is determined.
Evaluated after 4 courses of therapy. Partial response or stable disease undergo second-look conventional surgery & receive 2 more courses of induction therapy then re-evaluated. Those who do not achieve complete response (CR) after a total of 6 courses may undergo a third conventional surgery. Tumor that cannot be removed are removed from study therapy. Achievement of a CR at anytime are followed monthly for 1 year, every 6 months for 1 year, and then annually for 3 years.

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

19

Start Date

July 2004


Primary Completion Date

April 2007

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed newly diagnosed extracranial germ cell tumors, including 1 of
             the following types:

               -  Yolk sac carcinoma (endodermal sinus tumor)

               -  Embryonal carcinoma

               -  Choriocarcinoma

               -  Teratoma with mixed malignant elements (malignant teratoma)

          -  High-risk disease, defined as stage III or IV extragonadal germ cell tumors

          -  Must be enrolled on study within 21 days of diagnostic surgical procedure

        PATIENT CHARACTERISTICS:

        Age

          -  21 and under (at original diagnosis)

        Performance status

          -  ECOG 0-2

               -  Karnofsky 50-100% (in patients over 16 years of age)

               -  Lansky 50-100% (in patients 16 years of age and under)

        Life expectancy

          -  At least 2 months

        Hematopoietic

          -  Absolute neutrophil count at least 1,000/mm^3

          -  Platelet count at least 100,000/mm^3 (transfusion independent)

          -  Hemoglobin at least 10.0 g/dL (transfusion allowed)

        Hepatic

          -  Not specified

        Renal

          -  Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min OR

          -  Creatinine based on age as follows:

               -  No greater than 0.8 mg/dL (5 years and under)

               -  No greater than 1.0 mg/dL (6-10 years)

               -  No greater than 1.2 mg/dL (11-15 years)

               -  No greater than 1.5 mg/dL (over 15 years)

        Pulmonary

          -  FEV_1/FVC greater than 60% OR

          -  Children who are uncooperative must meet all of the following criteria:

               -  No dyspnea at rest

               -  No exercise intolerance

               -  Pulse oximetry greater than 94%

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

        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 - 21 Years

Accepts Healthy Volunteers

No

Contacts

Marcio A. Malogolowkin, MD, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT00066482

Organization ID

AGCT01P1

Secondary IDs

CDR0000316244

Responsible Party

Sponsor

Study Sponsor

Children's Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Marcio A. Malogolowkin, MD, Study Chair, Children's Hospital Los Angeles


Verification Date

October 2013