Combination therapy for advanced solid tumors and prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I/II study evaluates the safety and effectiveness of a combination of five oral drugs—hydroxychloroquine, metformin, sirolimus, dasatinib, and nelfinavir—in patients with advanced solid tumors and prostate cancer. The study employs a traditional 3+3 dose escalation design, starting with a base combination of three drugs and progressively adding the other two based on safety assessments. The initial cohort will consist of 18-30 patients, and the study aims to identify safe dosage levels for these combinations. If successful, this could lead to new treatment options for patients with limited alternatives.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient must have advanced solid tumor cancer of any type (Phase I) or advanced prostate cancer (Phase II). Prostate cancer patients must have a PSA of at least 0.1 ng/mL.
2. Tissue diagnosis documented by pathology report, or clinic note attesting to same.
3. Measurable / evaluable tumor by RECIST, quantitative blood biomarker, or radionuclide imaging
4. Voluntary, signed and dated, Institutional Review Board (IRB) approved consent form in accordance with regulatory and institutional guidelines.
5. Documented progression of disease during treatment with one or more standard systemic regimens. Single or multiple regimens of chemotherapy, hormone suppression therapy, radiation therapy, surgery, immunotherapy, or adoptive cell therapy are allowed.
6. 18 years of age or older.
7. ECOG performance status of 0-2.
8. Bilirubin ≤ 1.5 times upper limit of normal (ULN) and AST / ALT ≤ 3 times ULN. Subjects with Gilbert's syndrome may be included if the total bilirubin is \< 3 times ULN and the direct bilirubin is within normal limits.
9. Serum creatinine ≤ 1.5 times ULN.
10. Absolute neutrophil count (ANC) ≥ 1,000 cells / mm3
11. Platelet count ≥ 75,000 cells / mm3
12. Hemoglobin ≥ 9 g/ dL.
13. Fasting glucose ≤ 160 mg/dL or non-fasting glucose ≤ 200 mg/dL.
14. Urinalysis with no clinically significant abnormalities.
15. Adequately controlled blood pressure as determined by the treating investigator.
16. Subjects with the potential to produce children must agree to effective contraceptive method use during study participation.
17. Patients requiring narcotic analgesics must be on stable doses for at least 2 weeks prior to study entry.
18. Patients being considered for a dose level containing nelfinavir mesylate must discontinue any statin use within 48 hours of beginning study treatment.

Exclusion Criteria:

1. New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or history of ischemia on ECG.
2. Underlying psychiatric disorder requiring hospitalization within the last two years.
3. Clinically significant neurological disorder (Parkinson's disease, dementia, multiple sclerosis), as determined by the enrolling investigator.
4. Active, uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy.
5. Treatment with local or systemic radiation therapy, surgery, or investigational therapy within 28 days prior to registration.
6. Unwillingness or inability to comply with procedures required in this protocol.
7. Serious nonmalignant disease that could compromise protocol objectives in the opinion of the Investigator.
8. Patients who are receiving, coumadin, apixaban, argatroban or rivaroxaban.
9. Patients who are currently participating in any other clinical trial of an investigational product.
10. Any other mental incapacitation or psychiatric illness that would preclude study participation, as determined by the enrolling investigator.
11. Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.

Where it's running

• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting

Study contacts

• Study coordinator: HCC Clinical Trials Office
• Email: hcc-clinical-trials@musc.edu
• Phone: 843-792-9321

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.