Phase II Study of Intensive Chemotherapy With Autologous Peripheral Blood Stem Cell Support in Patients With Cisplatin Resistant Germ Cell Tumors
15 Years
N/A
Both
Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Ovarian Cancer, Testicular Germ Cell Tumor
Trial Information
Phase II Study of Intensive Chemotherapy With Autologous Peripheral Blood Stem Cell Support in Patients With Cisplatin Resistant Germ Cell Tumors
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Pierre Biron, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Leon Berard
Authority:
United States: Federal Government
Study ID:
CDR0000067015
NCT ID:
NCT00003852
Start Date:
March 1998
Completion Date:
Related Keywords:
- Childhood Germ Cell Tumor
- Extragonadal Germ Cell Tumor
- Ovarian Cancer
- Testicular Germ Cell Tumor
- recurrent malignant testicular germ cell tumor
- childhood germ cell tumor
- recurrent ovarian germ cell tumor
- extragonadal germ cell tumor
- Ovarian Neoplasms
- Neoplasms, Germ Cell and Embryonal
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