Gene Therapy and Radioactive Iodine in Treating Patients With Locally Recurrent Prostate Cancer That Did Not Respond to External-Beam Radiation Therapy

Phase 1

Terminated

• Conditions: Prostate Cancer
• Interventions: Biological: Ad5-CMV-NIS; Drug: liothyronine sodium; Genetic: reverse transcriptase-polymerase chain reaction; Other: laboratory biomarker analysis; Radiation: iodine I 131

• Registration Number: NCT00788307
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

* 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.

Secondary

* 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-11-03
• Study First Submitted: 2008-11-07
• Study First Submitted QC: 2008-11-07
• Study First Posted: 2008-11-10
• Primary Completion: 2018-02-07
• Study Completion: 2018-02-07
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Arm	iodine I 131	-
Experimental Arm	Ad5-CMV-NIS	-
Experimental Arm	liothyronine sodium	-
Experimental Arm	reverse transcriptase-polymerase chain reaction	-
Experimental Arm	laboratory biomarker analysis	-

Primary Outcome Measures

Name	Time	Method
Number of toxicity incidents by NCI CTCAE v3.0 criteria	3 years

Secondary Outcome Measures

Name	Time	Method
Time to PSA progression	3 years
Duration of PSA control	3 years
Survival	3 years
Incidence and duration of PSA response	3 years

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States