Study on HSV-tk and Valacyclovir Therapy with Brachytherapy for Recurrent Prostate Cancer

Sponsor: The Methodist Hospital Research Institute

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01913106

Provider View

This clinical trial is exploring a new treatment approach that combines gene therapy with brachytherapy to treat prostate cancer that has returned after initial radiation treatment. The study aims to see if this combination can help control the cancer and prevent it from spreading.

Patient Parameters

Program Overview

The study is testing a new treatment for prostate cancer that has come back after radiation therapy. It combines a gene therapy called HSV-tk with a medication called Valacyclovir and a type of radiation treatment known as brachytherapy. The goal is to see if this combination can effectively treat the cancer and stop it from spreading. The gene therapy works by introducing a special gene into cancer cells, which makes them sensitive to a drug that can kill them. This approach targets rapidly growing cancer cells while sparing normal cells.

Description

This study is investigating a new treatment for prostate cancer that has returned after radiation therapy. The treatment combines a gene therapy called HSV-tk with Valacyclovir and brachytherapy, a type of radiation treatment. The gene therapy involves using a virus to deliver a gene into cancer cells, making them sensitive to a drug that can kill them. This method aims to target cancer cells while leaving normal cells unharmed. The study will assess the safety and effectiveness of this treatment in patients who have limited treatment options. Participants will undergo evaluations to ensure they meet the study criteria and will receive the combination therapy to see if it can help control their cancer.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed return of prostate cancer without spread to other parts of the body, at least two years after completing radiation therapy.
  • Be in good general health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate blood cell counts and organ function as determined by specific blood tests.
  • Have a prostate volume less than 50 cc and a PSA level greater than 10 ng/ml within the past three months.
  • Not be on any other experimental cancer treatments.
  • Have no active infections or major medical or psychiatric illnesses.
  • Have an International Prostate Symptom Score (IPSS) less than 15.
  • Agree to sign a study-specific consent form before participating.

Exclusion Criteria

  • Have symptoms of cancer spread to other parts of the body.
  • Have a life expectancy of less than 10 years.
  • Be taking corticosteroids or other immunosuppressive drugs.
  • Be HIV positive.
  • Have acute infections requiring treatment.
  • Have liver cirrhosis or collagen vascular diseases.
  • Have an International Prostate Symptom Score (IPSS) greater than 15.
  • Have a prostate volume greater than 50 cc.
  • Have another active cancer, except for certain skin cancers.
  • Have allergies to valacyclovir, acyclovir, or cannot take oral pills.

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