Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Theodore Laetsch
Age
1–50
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients must be greater than 12 months and less than 50 years of age at the time of study enrollment.
Patients must have had histologic verification of an extracranial germ cell tumor that is not a pure mature teratoma.
Patients must have sufficient tumor tissue available to allow assessment of EGFR and mTOR pathway activation (see Section 5.2.3 for sample requirements)
Patients must have relapsed or refractory disease following at least two prior cisplatin containing chemotherapy regimens.
Patients must have measurable disease, documented according to RECIST criteria, or evaluable disease with a standard tumor marker (AFP and/or HCG) greater than 10 times the upper limit of normal.
Patients must have a Lansky or Karnofsky performance status score of ≥ 50. Use Karnofsky for patients \> 16 years of age and Lansky for patients ≤ 16 years of age.
Patients must have a life expectancy of greater than 8 weeks.
Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy.
* Patients must not have received myelosuppressive chemotherapy within 3 weeks of enrollment.
* Patients must be \> 7 days since treatment with hematopoetic growth factors (\>14 days for Neulasta).
* Patients must be \>7 days since therapy with a biologic agent and beyond the period for which adverse events of the biologic agent are known to occur if longer.
* Patients must be \>3 half-lives since therapy with a monoclonal antibody.
* Patients must be \>42 days since completion of any immunotherapy (i.e. tumor vaccines).
* Patients must be greater than 2 weeks since most recent palliative XRT and greater than 6 weeks since substantial bone marrow irradiation.
* Patients must be greater than 8 weeks since prior stem cell transplant or infusion and without evidence of active graft vs. host disease.
Adequate bone marrow function defined as:
* Peripheral absolute neutrophil count (ANC) of at least 1,000/ L
* Platelet count of at least 100,000/ L (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to enrollment)
* Creatinine clearance or radioisotope GFR 70 mL/min/1.73 m2 or
* Maximum serum creatinine (mg/dL) based on age/gender
Adequate liver function defined as:
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age
* SGPT (ALT) ≤ 2.5 x ULN (for the purpose of this study, the ULN for SGPT is 45 U/L)
* Serum albumin ≥ 2 g/dL.
Adequate central nervous system function defined as:
o Patients with seizure disorder may be enrolled if receiving non-enzyme inducing anticonvulsants and well controlled.
Serum cholesterol levels must be less than Grade 2 (\< 300 mg/dL), and serum triglyceride levels must be less than Grade 2 (\< 2.5 x ULN).
You may not be if
Patients who are pregnant or breast feeding will not be entered into the study as erlotinib is teratogenic. Pregnancy tests must be obtained in females who are post-menarchal. Post-menarchal females with HCG secreting tumors will be excluded as pregnancy can't be excluded. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of the study.
Concomitant medications
* Anticoagulants: Use of warfarin is not allowed while on study. Patients already on warfarin should use alternative anticoagulants while on this study. Warfarin must not have been administered within 7 days of enrollment.
* Smoking: Smoking induces CYP3A4/5 enzymes and decreases exposure to sirolimus and erlotinib. Thus, patients must not smoke for 10 days prior to enrollment and for the duration of therapy.
Drug interactions: Sirolimus and erlotinib are primarily metabolized by the CYP3A4/5 enzymes. Drug exposure is substantially effected by CYP inhibitors (increased exposure) and inducers (decreased exposure). Thus, concomitant administration of strong CYP3A4/5 inhibitors or inducers is prohibited while on therapy. See Appendix 1 for a list of these medications. Patients must not have received these medications for a minimum of 10 days prior to enrollment.
Prior treatment with mTOR or TORC1/2 inhibitors (eg, rapamycin, temsirolimus, everolimus, sirolimus) is NOT allowed.
