Everolimus in Refractory Testicular Germ Cell Cancer

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Brief Title

Everolimus in Refractory Testicular Germ Cell Cancer

Official Title

Phase II Study of Everolimus in Refractory Testicular Germ Cell Cancer.

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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Response rate

Secondary Outcome

 Favorable response rate

Condition

Germ Cell Tumor

Intervention

Everolimus

Study Arms / Comparison Groups

 everolimus 10 mg po daily
Description:  everolimus 10 mg po daily

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

Drug

Estimated Enrollment

15

Start Date

November 2011

Completion Date

June 2015

Primary Completion Date

June 2015

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
      

Gender

Male

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jozef Mardiak, Prof, , 

Location Countries

Slovakia

Location Countries

Slovakia

Administrative Informations


NCT ID

NCT01466231

Organization ID

GCTSK002


Responsible Party

Sponsor

Study Sponsor

National Cancer Institute, Slovakia


Study Sponsor

Jozef Mardiak, Prof, Principal Investigator, National Cancer Institute (NCI)


Verification Date

January 2016