Gene Therapy and Radioactive Iodine in Treating Patients With Locally Recurrent Prostate Cancer That Did Not Respond to External-Beam Radiation Therapy
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|ClinicalTrials.gov Identifier: NCT00788307|
Recruitment Status : Active, not recruiting
First Posted : November 10, 2008
Last Update Posted : February 9, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Biological: Ad5-CMV-NIS Drug: liothyronine sodium Genetic: reverse transcriptase-polymerase chain reaction Other: laboratory biomarker analysis Radiation: iodine I 131||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||July 2009|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
|Experimental: Experimental Arm||Biological: Ad5-CMV-NIS Drug: liothyronine sodium Genetic: reverse transcriptase-polymerase chain reaction Other: laboratory biomarker analysis Radiation: iodine I 131|
- Number of toxicity incidents by NCI CTCAE v3.0 criteria [ Time Frame: 3 years ]
- Time to PSA progression [ Time Frame: 3 years ]
- Survival [ Time Frame: 3 years ]
- Incidence and duration of PSA response [ Time Frame: 3 years ]
- Duration of PSA control [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00788307
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Brian J. Davis, M.D.||Mayo Clinic|