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

NCT00788307 | Terminated Phase 1 DMC

• 4 other identifiers: MC0252P30CA01508306-009392NCI-2009-01195
• 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 external-beam 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)

Experimental Arm

EXPERIMENTAL

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

Interventions

Ad5-CMV-NIS BIOLOGICAL

Experimental Arm

liothyronine sodium DRUG

Experimental Arm

reverse transcriptase-polymerase chain reaction GENETIC

Experimental Arm

laboratory biomarker analysis OTHER

Experimental Arm

iodine I 131 RADIATION

Experimental Arm

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 (EBRT) for stage T1-T2b, 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-EBRT 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 uIU/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 after the iodine I 131 radioiodine therapy on 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 or brachytherapy * 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

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: April 18, 2023

Record last verified: 2023-04

Locations

US (1)