Study on COAST Therapy for Advanced Solid Tumors and Prostate Cancer

Sponsor: Medical University of South Carolina

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05036226

Provider View

This clinical trial is testing the safety and effectiveness of a combination of up to five oral medications for treating advanced solid tumors and prostate cancer. The medications include hydroxychloroquine, metformin, sirolimus, dasatinib, and nelfinavir.

Patient Parameters

Program Overview

The study aims to find out if a combination of up to five drugs can safely and effectively treat advanced solid tumors and prostate cancer. The drugs are taken by mouth and include hydroxychloroquine, metformin, sirolimus, dasatinib, and nelfinavir. The trial is divided into two phases: Phase I focuses on safety, while Phase II evaluates how well the treatment works, especially in prostate cancer patients.

Description

This clinical trial is exploring a new treatment called COAST therapy for patients with advanced cancers who have no other satisfactory treatment options. The study is divided into two phases:

  • Phase I: This phase involves 18-30 patients with advanced cancer. The goal is to test the safety of different combinations of the COAST therapy drugs. The initial combination includes hydroxychloroquine, sirolimus, and metformin. If this combination is safe, additional combinations with dasatinib or nelfinavir will be tested. The study will determine the safest and most effective combination of these drugs.

  • Phase II: This phase focuses on patients with advanced prostate cancer. It will test the effectiveness of the COAST therapy combination that was found to be safe in Phase I. The main goal is to see if the treatment can stop the progression of prostate cancer for at least 16 weeks. Up to 29 patients will participate, and the study will continue if the treatment shows promise in the initial group of patients.

Patients will continue treatment unless they experience severe side effects, start a new cancer treatment, withdraw consent, or if the treatment is no longer in their best interest according to their doctor. The study will also stop if the cancer progresses within 16 weeks of starting COAST therapy.

Eligibility Criteria

Inclusion Criteria

  • Have advanced solid tumor cancer (Phase I) or advanced prostate cancer (Phase II) with a PSA level of at least 0.1 ng/mL.
  • Have a confirmed cancer diagnosis through a pathology report or clinic note.
  • Have measurable or evaluable tumors using specific medical criteria.
  • Provide signed consent to participate in the study.
  • Show disease progression after one or more standard treatments.
  • Be 18 years or older.
  • Have a performance status score of 0-2, indicating good overall health.
  • Have specific blood test results within normal limits, including bilirubin, AST/ALT, creatinine, neutrophil count, platelet count, hemoglobin, and glucose levels.
  • Have no significant abnormalities in urinalysis.
  • Have controlled blood pressure.
  • Agree to use effective contraception if there is a potential to produce children.
  • Be on stable doses of pain medication if needed.
  • Discontinue statin use 48 hours before starting treatment if taking nelfinavir.

Exclusion Criteria

  • Have severe heart disease or recent heart attack.
  • Have a psychiatric disorder requiring hospitalization in the last two years.
  • Have a significant neurological disorder like Parkinson's disease or dementia.
  • Have an active, uncontrolled infection requiring treatment.
  • Have received recent radiation, surgery, or investigational therapy within 28 days.
  • Be unable or unwilling to follow study procedures.
  • Have a serious non-cancerous disease that could affect the study.
  • Be taking certain blood thinners like coumadin or rivaroxaban.
  • Be participating in another clinical trial.
  • Have a mental condition that prevents study participation.
  • Be a prisoner or involuntarily detained for treatment.

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