Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors

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Brief Title

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors

Official Title

Phase II Study of Intensive Chemotherapy With Autologous Peripheral Blood Stem Cell Support in Patients With Cisplatin Resistant 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 chemotherapy with peripheral stem cell transplantation
      may allow patients to tolerate higher doses of chemotherapy and kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and peripheral
      stem cell transplantation in treating patients who have germ cell tumors that have not
      responded to previous chemotherapy.
    

Detailed Description

      OBJECTIVES: I. Determine the complete response rate (chemotherapy complete response,
      pathological complete response, or surgical complete response) to intensive chemotherapy with
      autologous peripheral blood stem cell support in patients with cisplatin resistant germ cell
      tumors. II. Determine duration of complete response and survival of these patients after this
      therapy. III. Determine the toxic effects of this regimen in these patients. IV. Determine
      the pharmacokinetics of this regimen and the relationship between these pharmacokinetics,
      nature and duration of response to treatment, and the toxic effects in these patients.

      OUTLINE: This is an open label, multicenter study. Patients receive epirubicin IV over 15
      minutes and paclitaxel IV over 3 hours on day 1, then filgrastim (G-CSF) subcutaneously (SQ)
      on days 5-14. Peripheral blood stem cells (PBSC) are collected on days 13 and 14. This course
      is repeated beginning on day 15. Patients then undergo a three part intensification regimen.
      Part I: Patients receive cyclophosphamide IV and thiotepa IV by continuous infusion on days
      34 and 35. PBSC are reinfused on day 38, and G-CSF SQ is administered from day 39 until blood
      cell counts recover. Part II: Patients receive etoposide IV over 2 hours, ifosfamide IV over
      4 hours, and carboplatin IV over 6 hours on days 62-66. PBSC are reinfused on day 70, and
      eventually G-CSF begins on day 71. Part III: Patients receive etoposide, ifosfamide, and
      carboplatin on days 90-94 as in part II. PBSC are reinfused on day 98 and eventually G-CSF
      begins on day 99. Patients are followed every month for the first year, every 2 months for
      the second year, every 6 months for the third and fourth years, then annually thereafter.

      PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 2 years.
    

Study Phase

Phase 2

Study Type

Interventional




Condition

Childhood Germ Cell Tumor

Intervention

filgrastim


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

45

Start Date

March 1998

Completion Date

March 2000

Primary Completion Date

March 2000

Eligibility Criteria

        DISEASE CHARACTERISTICS: Histologically or cytologically proven germ cell tumor Seminoma or
        nondysgerminoma origin Gonadal (testicular or ovarian) OR Extragonadal OR Retroperitoneal
        OR Primitive mediastinal AFP elevated and/or HCG greater than 200 mIU/mL No growing
        teratoma Refractory disease to any treatment line Refractory disease is defined by the
        elevation of AFP and/or HCG during the chemotherapy Refractory to treatment line consisting
        of one conventional dose of cisplatin (dose intensity greater than 33 mg/m2/week) OR at
        least 1 month since last course of chemotherapy with or without increase in the size of
        measurable lesions OR Received 2 regimens of conventional chemotherapy, typically the
        following: Bleomycin, etoposide, and cisplatin: 3-4 courses* OR Etoposide and cisplatin: 4
        courses* AND Vinblastine, etoposide, ifosfamide, cisplatin: 4 courses of 3 week regimen (as
        standard salvage chemotherapy)* * Unless patients could be treated with a first line
        conventional treatment OR a first salvage conventional treatment especially patients who
        could be treated with T93 good prognosis protocol or T93 bad prognosis protocol or IT94
        protocol Bidimensionally measurable disease OR Significant elevation of tumor markers: HCG,
        free beta-HCG, AFP OR Evaluable disease plus increase in tumor markers No germ cell CNS
        tumors or clinically significant CNS metastases

        PATIENT CHARACTERISTICS: Age: Over 15 Performance status: ECOG 0-2 Life expectancy: Greater
        than 3 months Hematopoietic: WBC greater than 3,000/mm3 AND Platelet count greater than
        150,000/mm3 Hepatic: Bilirubin less than 1.5 times normal SGOT/SGPT less than 2 times upper
        limit of normal (ULN) Alkaline phosphatase less than 2 times ULN Gamma glutamyl transferase
        less than 2 times ULN Renal: Creatinine less than 1.4 mg/dL Creatine clearance greater than
        60 mL/min Cardiovascular: No cardiac insufficiency LVEF at least 50% Other: HIV negative No
        other malignancy except basal cell skin cancer

        PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
        Characteristics No prior intensive chemotherapy with stem cell support Endocrine therapy:
        Not specified Radiotherapy: Prior prophylactic anterior irradiation of the diaphragm for
        stage I seminoma allowed Surgery: Not specified
      

Gender

All

Ages

15 Years - 120 Years

Accepts Healthy Volunteers

No

Contacts

Pierre Biron, MD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT00003852

Organization ID

CDR0000067015

Secondary IDs

FRE-FNCLCC-GETUG-04


Study Sponsor

UNICANCER


Study Sponsor

Pierre Biron, MD, Study Chair, Centre Leon Berard


Verification Date

June 2016