Clinical trial NCT01466231: Everolimus in Refractory Testicular Germ Cell Cancer
Official title: Phase II Study of Everolimus in Refractory Testicular Germ Cell Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Germ Cell Tumor
Keywords: refractory germ cell cancer
everolimus
Lead sponsor: National Cancer Institute, Slovakia
Sponsor class: OTHER_GOV
First posted: 2011-11-06
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Everolimus in refractory testicular germ cell cancer. Everolimus 10 mg /day/ is administered to the patient until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements. Feasibility of surgical resection will be assessed after every 2 cycles of the treatment in patients with partial response.

Detailed description: Treatment Schedule: Everolimus will be administered at a dose of 10mg/day orally once a day. One cycle of therapy consists of 28 days.

Estimated duration of treatment: Until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.

Feasibility of surgical resection will be assessed after every 2 cycles of the treatment in patients with partial response.

Eligibility criteria: Inclusion Criteria:

1. Signed written informed consent
2. Men aged 18 years or older
3. ECOG performance status: 0-2,
4. Histological confirmed extracranial primary germ cell cancer, seminoma, or nonseminoma
5. Rising serum markers (i.e., alpha-fetoprotein and human chorionic gonadotropin) on sequential measurement or biopsy-proven unresectable germ cell cancer
6. Refractory GCTs e.g. patients relapsing after high-dose chemotherapy or for patients non fit enough for high-dose chemotherapy
7. Primary mediastinal GCTs in first relapse
8. Patient's disease must not be amenable to cure with either surgery or chemotherapy in the opinion of investigator,
9. Measurable disease radiological
10. Adequate hematologic function defined by WBC \> 4000/mm3, platelet count \> 100 000/mm3 and hemoglobin level \> 9g/dl.
11. Adequate liver function defined by a total bilirubin level \< 1.5 ULN, and ALT, AST \< 2,5 ULN and adequate renal function defined by serum creatinine ≤ 1.5 x ULN.
12. At least 2 weeks must have elapsed since the last radiotherapy and/or chemotherapy before study entry,
13. At least 4 weeks must have elapsed since the last major surgery
14. Complete recovery from prior surgery, and/or reduction of all adverse events from previous systemic therapy or radiotherapy to grade 1,
15. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, -

Exclusion Criteria:

1. Patients who do not fit inclusion criteria,
2. Other prior malignancy except successfully treated non melanoma skin cancer
3. Prior treatment with mTOR inhibitor
4. No other concurrent approved or investigational anticancer treatment, including surgery, radiotherapy, chemotherapy, biologic-response modifiers, hormone therapy, or immunotherapy
5. Female patients,
6. Patients infected by the Human Immunodeficiency Virus (HIV),
7. Patients with other severe acute or chronic medical condition, or laboratory abnormality that would impair, in the judgment of investigator, excess risk associated with study treatment, or which, in judgment of the investigator, would make the patient inappropriate for entry into this study,
8. Inability of oral intake, or drug absorption (e.g. malabsorption syndrome)
9. Hypersensitivity to any compound of the drug,
10. Sexually active men not using effective birth control if their partners are women of child-bearing potential.
11. Patients with active CNS metastasis

Primary outcomes:
measure: Response rate
timeFrame: 36 month
Secondary outcomes:
measure: Favorable response rate
timeFrame: 36 month
measure: Clinical benefit rate
timeFrame: 36 month
measure: Progression-free survival
timeFrame: 36 month
measure: Toxicity
timeFrame: 36 month
measure: Frequency of grade III and IV adverse events
timeFrame: 36 month
measure: Association between clinical outcome and biomarkers
timeFrame: 36 month
measure: Serum tumor markers response
timeFrame: 36 month
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: National Cancer Institute
Study officials:
affiliation: National Cancer Institute (NCI)
name: Jozef Mardiak, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, Slovakia
name: Michal Mego, Ass.prof.
role: STUDY_CHAIR
References: