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

NCT00788307 | Terminated Phase 1 DMC

• 3 other identifiers: MC0252P50CA09195606-009392
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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 definitive radiation therapy.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer; stage I prostate cancer; stage II prostate cancer

Outcome Measures

Primary Outcomes (1)

• Number of toxicity incidents by NCI CTCAE v3.0 criteria

  3 years

Secondary Outcomes (4)

• Time to PSA progression

  3 years

• Survival

  3 years

• Incidence and duration of PSA response

  3 years

• Duration of PSA control

  3 years

Study Arms (1)

Treatment (in situ gene therapy)

EXPERIMENTAL

Patients receive intraprostatic Ad5CMV-NIS via transperineal injection on day 1. Patients also receive iodine I 123 PO QD on day 4. Patients with sufficient prostatic iodine I-123 uptake receive a single therapeutic oral dose of iodine I-131 on day 6 ±1 day. Patients with intact thyroid glands receive liothyronine sodium PO TID for 10 days prior and for 15 days following administration of iodine I-123.

Biological: Ad5-CMV-NIS; Drug: Liothyronine Sodium; Genetic: Reverse Transcriptase Polymerase Chain Reaction; Other: laboratory biomarker analysis; Radiation: Iodine I 131; Radiation: Iodine I 123

Interventions

Reverse Transcriptase Polymerase Chain Reaction GENETIC

Peripheral blood cells (20 ml of plasma collected in two CPT tubules) will be evaluated for evidence of virus DNA

Also known as: RT-PCR, reverse transcriptase-polymerase chain reaction

Treatment (in situ gene therapy)

Ad5-CMV-NIS BIOLOGICAL

Given intraprostatically

Also known as: recombinant type 5 adenovirus carrying the human NIS gene linked to the CMV promotor

Treatment (in situ gene therapy)

Liothyronine Sodium DRUG

Given PO

Also known as: Cytomel, Triostat

Treatment (in situ gene therapy)

laboratory biomarker analysis OTHER

Correlative study

Treatment (in situ gene therapy)

Iodine I 131 RADIATION

Given PO

Also known as: 131I, iodine 131, I-131, Sodium Iodide I-131

Treatment (in situ gene therapy)

Iodine I 123 RADIATION

Given PO

Also known as: I-123, iodine 123, 123I, Sodium Iodide I-123

Treatment (in situ gene therapy)

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed recurrent adenocarcinoma of the prostate within the past year * No transitional cell, small cell, or squamous cell carcinoma of the prostate * Local recurrence * Disease recurred ≥ 18 months after completion of prior external beam radiotherapy or brachytherapy for stage T1-T3, N0/X, M0 disease * Biochemical failure as defined by the Phoenix definition (rise in PSA by 2 ng/mL or more above the nadir PSA) * PSA ≥ 0.3 ng/mL to \< 20 ng/mL measured within the past 30 days * Pre-treatment PSA \< 50 ng/mL * Prior locally recurrent hormone-refractory disease allowed * American Urologic Association Obstructive Symptom Index Score ≤ 24 * No known standard therapy that is potentially curative or definitely capable of extending life expectancy * No evidence of or history of metastatic adenocarcinoma of the prostate * Negative radiographic metastatic work-up including whole-body radionuclide bone scan, CT and/or MR scan of the pelvis and abdomen, and chest x-ray * Patients with suspicious areas on conventional imaging studies are eligible provided they are biopsy negative * No known CNS metastases * No prostate size \> 140 cc PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 12 weeks * ANC ≥ 1,500/μL * Platelet count ≥ 100,000/μL * Hemoglobin ≥ 8.5 g/dL * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) * INR ≤ 1.4 times ULN * Creatinine ≤ 1.5 times ULN * Thyroid-stimulating hormone 0.3-5.0 μIU/mL and free thyroxine 0.8-1.87 ng/dL * Willing to provide biologic specimens and participate in imaging studies as required * Willing to maintain a low-iodine diet for 12 days * Starting 7 days prior to study virus injection continuing until study day 5 * No more than 1 of the following renal/genitourinary toxicities: * Bladder spasms * Dysuria (painful urination) * Genitourinary fistula * Hemoglobinuria * Incontinence * Operative injury to bladder and/or ureter * Proteinuria * Renal failure * Uretal obstruction * Urinary frequency/urgency * Urinary retention * Urine color change (not related to other dietary or physiologic cause \[e.g., bilirubin, concentrated urine, or hematuria\]) * Other renal/genitourinary toxicities * No urinary tract infection within 72 hours prior to registration * No pubic arch interference study demonstrating unacceptable prostate access by the transperineal approach * No absence of rectum or other anatomic features that would preclude transperineal needle insertion into the prostate * No coagulopathy that contraindicates transperineal and intraprostatic needle insertion * No other cancer within the past 2 years, except for squamous cell and basal cell skin cancers * No uncontrolled infection or fever \> 100°F * No known cardiac disease * No seizure disorder * No documented history of HIV positivity or other acquired immunodeficiency disorder or congenital immunodeficiency disorder PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from acute, reversible effects of prior chemotherapy * Androgen-deprivation therapy (if applicable) initiated more than 3 months prior to registration * Patients who have undergone bilateral orchiectomy are eligible if they meet all other criteria * At least 6 weeks since prior bicalutamide, nilutamide, or oral or intravenous iodinated contrast * At least 4 weeks since prior chemotherapy (6 weeks for mitomycin C or nitrosoureas), immunotherapy, biologic therapy, or other experimental drugs * At least 4 weeks since prior and no concurrent anti-androgens (e.g., flutamide, estrogens, ketoconazole, PC-SPES, finasteride, or megestrol acetate) * At least 2 weeks since prior and no concurrent exogenous corticosteroids * Patients clinically proven to require maintenance steroids allowed provided there has been no change in their dose within the past 6 weeks * No antibiotic therapy within the past 72 hours * No prior organ transplantation * No prior salvage prostatectomy * No other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational * No concurrent prophylactic use of colony-stimulating factors * No concurrent enrollment in any other study involving a pharmacologic agent (drugs, biologics, immunotherapy approaches, gene therapy) whether for symptom control or therapeutic intent

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Triiodothyronine; Reverse Transcriptase Polymerase Chain Reaction; Iodine-131; Iodine-123

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Thyronines; Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Thyroxine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques

Study Officials

• Brian J. Davis, M.D.

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2008
• First Posted: November 10, 2008
• Study Start: November 3, 2008
• Primary Completion: February 7, 2018
• Study Completion: February 7, 2018
• Last Updated: July 22, 2026

Record last verified: 2026-07

Locations

US (1)