Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2025-12-24 @ 7:01 PM
NCT ID:
NCT01266057
Eligibility Criteria:
Inclusion Criteria:
1. Patients with advanced or metastatic cancers that are refractory to standard therapy, relapsed after standard therapy, or who have no standard therapy available that improves survival by at least three months.
2. Patients must be \>/= 18 years.
3. Patients must be \>/= 3 weeks beyond treatment with a cytotoxic chemotherapy regimen, or therapeutic radiation, or major surgery. Patients may have received palliative localized radiation immediately before or during treatment provided that radiation is not delivered to the only site of disease being treated under this protocol. For biologic/targeted agents patients must be \>/= 5 half-lives or \>/= 3 weeks form the last dose (whichever comes first).
4. ECOG performance status \</= 2
5. Patients must have adequate organ and marrow function defined as: absolute neutrophil count \>/= 1,000/mL;platelets \>/=50,000/mL; creatinine \</= 2 X ULN; total bilirubin \</= 2.0 (exceptions may apply to benign non-malignant indirect hyperbilirubinemia such as Gilbert syndrome); ALT(SGPT) \</= 5 X ULN; Exception for patients with liver metastasis: total bilirubin \</= 3 x ULN; ALT(SGPT) \</= 8 X ULN;cholesterol \</= 350 mg/dL; triglycerides \</= 400 mg/dL (sirolimus and hydroxychloroquine only).
6. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose.
7. Patients must be able to understand and be willing to sign a written informed consent document.
Exclusion Criteria:
1. Uncontrolled intercurrent illness, including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support.
2. Pregnant or lactating women.
3. History of hypersensitivity to sirolimus.
4. History of hypersensitivity to vorinostat
5. History of hypersensitivity to hydroxychloroquine
6. History of hypersensitivity to any component of the formulation.
7. Patients unwilling or unable to sign informed consent document.
8. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
9. Patients with known glucose-6-phosphate dehydrogenase deficiency.
10. Patients with porphyria cutanea tarda.
11. Patients with psoriasis.
12. Patients with pre-existing maculopathy or retinopathy of the eye.
13. Patients who have a pre-existing myopathy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01266057
Study Brief:
Protocol Section:
NCT01266057