Gene Therapy and Radioactive Iodine in Treating Patients With Locally Recurrent Prostate Cancer That Did Not Respond to External-Beam Radiation Therapy
RATIONALE: Radioactive drugs, such as radioactive iodine, may carry radiation directly to tumor cells and not harm normal cells. Placing a gene called Ad5CMV-NIS in prostate cancer cells may help the prostate cells take in more radioactive iodine and thus kill the cancer cells. Drugs, such as liothyronine sodium, may protect the thyroid from the side effects of radioactive iodine.
PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy given together with radioactive iodine in treating patients with locally recurrent prostate cancer that did not respond to external-beam radiation therapy.
Drug: liothyronine sodium
Genetic: reverse transcriptase-polymerase chain reaction
Other: laboratory biomarker analysis
Radiation: iodine I 131
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of In Situ Gene Therapy for Locally Recurrent Prostate Cancer Following Radiation Therapy Failure Using Sodium/Iodide Symporter and Radioiodine|
- Number of toxicity incidents by NCI CTCAE v3.0 criteria [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Time to PSA progression [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Incidence and duration of PSA response [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Duration of PSA control [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
|Experimental: Experimental Arm||Biological: Ad5-CMV-NIS Drug: liothyronine sodium Genetic: reverse transcriptase-polymerase chain reaction Other: laboratory biomarker analysis Radiation: iodine I 131|
- To determine the safety and tolerance of Ad5CMV-NIS administered intraprostatically followed by radioiodine treatment in patients with locally recurrent adenocarcinoma of the prostate following external beam radiotherapy.
- To determine the maximum tolerated dose of Ad5CMV-NIS in these patients.
- To evaluate the PSA response rates, duration, and time to PSA progression in these patients.
- To evaluate the immune response to Ad5CMV-NIS.
OUTLINE: This is a dose-escalation study of Ad5CMV-NIS.
Patients receive intraprostate Ad5CMV-NIS, via transperineal injection under anesthesia, on day 1. They receive dosimetry oral iodine I 123 on day 4 and undergo image studies periodically for the next 24 hours for measurement of radioiodine uptake. Patients receive therapeutic oral iodine I 131 on day 5.
All patients with intact thyroid glands (i.e., not previously surgically removed or ablated) receive TSH suppressive doses of oral liothyronine sodium 3 times daily for 10 days prior and for 15 days post administration of iodine I 123.
Blood samples are collected periodically for measurement of PSA, fT4, and TSH; and peripheral blood cells are monitored for evidence of virus DNA via quantitative reverse-transcriptase-PCR.
After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 8 years. A transrectal tumor biopsy is to be performed at 3 months and 1 year post-treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00788307
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Clinical Trials Referral Office 855-776-0015|
|Principal Investigator: Brian J. Davis, M.D.|
|Study Chair:||Brian J. Davis, M.D.||Mayo Clinic|