Status:
TERMINATED
Gene Therapy and Radioactive Iodine in Treating Patients With Locally Recurrent Prostate Cancer That Did Not Respond to External-Beam Radiation Therapy
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18-120 years
Phase:
PHASE1
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 ...
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 p...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 3 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2018
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00788307
Start Date
November 3 2008
End Date
February 7 2018
Last Update
April 18 2023
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905