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

Ovarian Cancer Clinical Trial

Official title:

Phase II Study of Intensive Chemotherapy With Autologous Peripheral Blood Stem Cell Support in Patients With Cisplatin Resistant Germ Cell Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00003852
• Other study ID #: CDR0000067015
• Secondary ID: FRE-FNCLCC-GETUG
• Status: Terminated
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: June 22, 2016
• Start date: March 1998
• Est. completion date: March 2000

Study information

• Verified date: June 2016
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: March 2000
• Est. primary completion date: March 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 120 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Childhood Germ Cell Tumor
• Extragonadal Germ Cell Tumor
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Ovarian Cancer
• Testicular Germ Cell Tumor
• Testicular Neoplasms

Intervention

Biological:
• filgrastim

Drug:
• carboplatin

• cyclophosphamide

• epirubicin hydrochloride

• etoposide

• ifosfamide

• paclitaxel

• thiotepa

Procedure:
• bone marrow ablation with stem cell support

• peripheral blood stem cell transplantation

Locations

Country	Name	City	State
France	Centre Paul Papin	Angers
France	CHR de Besancon - Hopital Jean Minjoz	Besancon
France	Institut Bergonie	Bordeaux
France	Centre Regional Francois Baclesse	Caen
France	Centre Jean Perrin	Clermont-Ferrand
France	Centre de Lute Contre le Cancer,Georges-Francois Leclerc	Dijon
France	CHR de Grenoble - La Tronche	Grenoble
France	Clinique Saint Michel	La Rochelle
France	Centre Leon Berard	Lyon
France	Institut J. Paoli and I. Calmettes	Marseille
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier
France	Centre Antoine Lacassagne	Nice
France	Hopital d'Instruction des Armees du Val de Grace	Paris
France	Institut Jean Godinot	Reims
France	Centre Henri Becquerel	Rouen
France	Centre Rene Huguenin	Saint Cloud
France	Hopitaux Universitaire de Strasbourg	Strasbourg
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France,