Status:
COMPLETED
Sirolimus or Vorinostat and Hydroxychloroquine in Advanced Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Advanced Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The goal of this clinical research study is to find the highest tolerable dose of sirolimus or vorinostat that can be given in combination with hydroxychloroquine to patients with advanced cancer. The...
Detailed Description
Study Drug Dose Level: If you are found to be eligible to take part in this study, you will be assigned to a dose level of hydroxychloroquine and either sirolimus or vorinostat, based on when you joi...
Eligibility Criteria
Inclusion
- 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.
- Patients must be \>/= 18 years.
- 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).
- ECOG performance status \</= 2
- 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).
- 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.
- Patients must be able to understand and be willing to sign a written informed consent document.
Exclusion
- Uncontrolled intercurrent illness, including, but not limited to, uncontrolled infection, uncontrolled asthma, need for hemodialysis, need for ventilatory support.
- Pregnant or lactating women.
- History of hypersensitivity to sirolimus.
- History of hypersensitivity to vorinostat
- History of hypersensitivity to hydroxychloroquine
- History of hypersensitivity to any component of the formulation.
- Patients unwilling or unable to sign informed consent document.
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
- Patients with known glucose-6-phosphate dehydrogenase deficiency.
- Patients with porphyria cutanea tarda.
- Patients with psoriasis.
- Patients with pre-existing maculopathy or retinopathy of the eye.
- Patients who have a pre-existing myopathy.
Key Trial Info
Start Date :
April 28 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2021
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT01266057
Start Date
April 28 2011
End Date
February 11 2021
Last Update
March 4 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030