Gene Therapy and Radioactive Iodine in Treating Patients with Locally Recurrent Prostate Cancer that Did Not Respond to External-Beam Radiation Therapy
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: I What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 06-009392
NCT ID: NCT00788307
Sponsor Protocol Number: MC0252
About this study
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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
- 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
- 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
- Operative injury to bladder and/or ureter
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Brian Davis, M.D., Ph.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office