Clinical Trials
Clinical trials are studies that are performed to try to demonstrate the effectiveness of new therapies compared to existing standard treatments. While the terms "investigational" or "experimental" may be used, these studies have been selected because of potential benefit with reasonable side effects, have been extensively researched in pre-clinical or limited clinical trials, have been reviewed by the Emory University Institutional Review Board for informed consent, will be carefully monitored for safety and response, and will provide the foundation for future treatment of urologic conditions, whether benign or malignant. For urinary tract tumors, the Emory Urology team works with colleagues in Medical Oncology and Radiation Oncology in the Winship Cancer Institute of Emory University for comprehensive oncologic care. Clinical trials are constantly being closed (completed) and opened (started), so periodic discussions with your urologist will keep you updated about the latest studies that might be appropriate for you.
Participating in a clinical trial begins with a discussion between the patient and physician. If there is further interest, additional discussions are started with the research coordinator and a screening is completed to qualify the patient. Once qualified, the patient is asked to sign an informed consent and discuss the study with family members or primary physician. Clinical trial patients have direct access to the research staff to answer any questions before, during or after a study.
Participation is voluntary and will not affect the quality of care you receive at Emory Urology.
The following studies are open for enrollment at this time:
The research staff at Emory Urology has a key role in providing proper care and communication throughout the study period. Please feel free to contact us at anytime if you have questions regarding participation.
Michelle Faurot, BS
Clinical Research Co-ordinator
404-778-4162
ELIGIBILITY:
• Males having radical prostatectomy
EXCLUSION CRITERIA:
• Refusal to sign informed consent.
****At the time of surgery, the following must be sent with the specimen to pathology:
• Sterile urine specimen
• 3 green top blood tubes
• 2 red top blood tubes
SPONSOR: None
PI: Andrew Young, MD PhD; Viraj Master, MD PhD, 8-3859 PIC #10253
COLLABORATORS: Hunter T. Hardy, MD; John A. Petros, MD
CONTACT: Michelle Faurot, 404-778-4162
FACBC PET Study for Detection and Staging of Recurrent Prostate Cancer
ELIGIBILITY:
• Suspected recurrent prostate carcinoma after presumed definitive therapy for organ confined disease as defined by:
1) ASTRO criteria of
a) 3 consecutive rises of PSA or earlier if clinically appropriate, and/or
b) Nadir + 2.0 after radiotherapy or cryo, and/or
2) > 0.3 after prostatectomy.
• > 1 yr post- prostatectomy or cryotherapy; > 2 yr post- brachytherapy or XRT (PSA bump)
• Bone scan negative for metastases
• Ability to lie still for 1 hour for PET scanning
EXCLUSION CRITERIA:
• Not a surgical or biopsy candidate
TREATMENT:
After routine imaging studies (bone scan, CT pelvis, Prostascint scan), FACBC PET scan will be performed. Then, active sites within prostate bed or extraprostatic will be biopsied.
SPONSOR: NIH
PI: David Schuster, MD, 8-5236; Peter Nieh, MD, 8-5754 PIC #10152; Viraj Master, MD, PhD 8-5881 PIC #10253
CONTACT: Michelle Faurot, 404-778-4162
RTOG 0712 A Phase II Randomized Study For Patients With Muscle-Invasive Bladder Cancer Evaluating Transurethral Surgery And Concomitant Chemoradiation By Either BID XRT Plus 5-FU & Cisplatin Or QD XRT Plus Gemcitabine Followed By Selective Bladder Preservation And Gemcitabine/Cisplatin Adjuvant Chemotherapy
ELIGIBILITY:
• Operable patients with muscularis propria invasion carcinoma of the bladder, all histologies
• AJCC Stages T2-T4a, NX or N0, M0
• No histologic evidence of tumor invasion into the stroma of the prostate
• No tumor-related hydronephrosis
TREATMENT:
After TURB, randomized to BID XRT + 5FU/cis-platinum chemo (2.5 wks) vs QD XRT + gemcitabine (4 wks); repeat cysto - if response, complete same chemoradiation x 2 wks, then gem-cis for 4 mo. If no response, then radical cystectomy in 1-5 wks, followed by gem-cis for 4 mo.
SPONSOR: RTOG
PI: Peter Rossi, MD
COLLABORATORS: Asesh Jani, MD; Viraj Master, MD; Peter Nieh, MD
CONTACT: Peter Rossi, MD 8-3658
ELIGIBILITY:
• Any solid renal neoplasm including oncocytoma, papillary renal cell carcinoma and transitional cell carcinoma of the kidney (renal pelvis/calyx, etc.)
• Biopsy specimens are ok also as long as no additional biopsies are taken just for research.
EXCLUSION CRITERIA:
-Refusal to sign the consent form.
****At the time of surgery, the following must be sent with the specimen to pathology:
• Sterile urine specimen
• 3 green top blood tubes
• 2 red top blood tubes
SPONSOR: To be determined
PI: Andrew Young, MD PhD
COLLABORATORS: Fray F. Marshall, MD; John A. Petros, MD; Hunter Hardy, MD
CONTACT: Michelle Faurot, 404-778-4162
Adjuvant cG250 - Adjuvant RCC
G250 MoAb - A Randomized Double Blind Phase III Study to Evaluate Adjuvant cG250 Treatment Versus Placebo in Patients with Clear Cell RCC and High Risk of Recurrence
ELIGIBILITY:
• Clear cell ca
• Regional lymphadenectomy
• pT3b, pT3c, or pT4 N0M0
• Any T with N+
• pT1b or T2 with microscopic vascular invasion and Fuhrman > 3, or T3a and Fuhrman > 3.
EXCLUSION CRITERIA:
• Non clear cell
TREATMENT:
Randomized to receive weekly cG250 or placebo for 24 weeks.
SPONSOR: Wilex
PI: Peter Nieh, MD PIC # 10152; Wayne Harris, MD 8-1900 PIC #10571
CONTACT: No longer enrolling
A Randomized Double Blind Phase III Study To Evaluate Adjuvant Sunitinib vs Sorafenib vs Placebo In Patients With Clear Cell RCC And High Risk Of Recurrence
ELIGIBILITY:
• Clear cell and non-clear cell (except collecting duct or medullary)
• Pre-op: >cT1b N0 (or fully resectable N1-2 nodes) M0
• Post-op: pT1b G3-4, pT2-4 (any G) N0 or >pT1b (any G) N(any G, fully resected) M0
EXCLUSION CRITERIA:
• Collecting duct or medullary
• Distant metastases
• Significant cardiovascular disease (severe HT, MI, unstable angina, CHF, cardiac arrhythmia, or peripheral vascular disease)
• HIV
SPONSOR: ECOG
PI: Wayne Harris, MD, 8-1900, PIC #10571
CONTACT: Susan McKoy RN, 8-3448, PIC #18966
A Randomized Double Blind Phase III Study To Evaluate Adjuvant Sunitinib vs Placebo In Patients With Clear Cell RCC And High Risk Of Recurrence
ELIGIBILITY:
• Clear cell and non-clear cell (except collecting duct or medullary)
• Pre-op: >cT1b N0 (or fully resectable N1-2 nodes) M0
• Post-op: pT1b G3-4, pT2-4 (any G) N0 or >pT1b (any G) N(any G, fully resected) M0
EXCLUSION CRITERIA:
• Collecting duct or medullary
• Distant metastases
• Significant cardiovascular disease (severe HT, MI, unstable angina, CHF, cardiac arrhythmia, or peripheral vascular disease)
• HIV
SPONSOR: Pfizer
PI: Viraj Master, MD, PhD, 8-5881, PIC #10253
CONTACT: Michelle Faurot, 404-778-4162
ELIGIBILITY:
• Newly diagnosed advanced RCC pre- or post-nephrectomy
Any T, any N, M1
Any T, N2 with indicator nodal metastasis, M0
Clear cell predominantly
• Planned nephrectomy within 1 mo (synchronous metastasis) OR Lesion accessible for excisional biopsy/metastasectomy (synchronous or metachronous metastasis) within 1 mo AND stable (progression/recurrence free) for > 3 mo after nephrectomy
• Measurable lesion > 1.0 cm remains after nephrectomy (bone excluded) as indicator lesion
• ECOG 0,1
• No brain mets on MRI
• Prior systemic therapy OK if stable for 3 mo after nephrectomy AND stable off systemic therapy >6 wks
EXCLUSION CRITERIA:
• Non-clear cell histology
• Bilateral nephrectomy
• Serious medical condition
• DM type I (insulin for type II OK)
• Active autoimmune disorders (e.g. RA, inflammatory bowel disease, SLE, MS)
• Planned excision/treatment of indicator lesion during study
TREATMENT:
Tumor (nephrectomy or metastasectomy) and leukaphersis collections followed by dendritic cell vaccine production. Induction period (24 weeks): vaccine q2 weeks x 5, q4 weeks x 4. Booster period: vaccine q 3 mo until confirmed progression.
SPONSOR: Argos Therapeutics
PI: Viraj Master, MD, PhD, 8-5881, PIC #10253
CONTACT: Michelle Faurot, 404-778-4162
TREATMENT: Adjustible device for female patients suffering from incontinence
INCLUSION: Female over age of 18 diagnosed with urinary incontinence with or without urethral hypermobility, candidates for surgical intervention for stress incontinence, normal cystourethroscopy, have failed at least 6 months of previous treatment
EXCLUSION:Pregnant, insulin dependent diabetic, auto-immune disease, bladder cancer, bladder stones, urethral stricture
SPONSOR: Uromedica
PI: Niall Galloway, MD
Collaborators: Fray Marshall, MD
CONTACT: Michelle Faurot, 404-778-4162
No longer enrolling 4/10
DESCRIPTION: Patients collect pads for a 24 hour period and fill out questionnaire. Working to find correlation between quality of life and incontinence in men.
INCLUSION: Male 6 months out from prostatectomy experiencing incontinence
EXCLUSION: inability to fill out questionnaire, inability to collect pads for 24 hour period and bring them to clinic
SPONSOR: NYU
PI: Nedra Hood, MD
Collaborators: Niall Galloway, MD; Ken Ogan, MD; Viraj Master, MD; John Pattaras, MD; Hark Chang, MD; Peter Nieh, MD; Jeff Carney, MD; Chad Ritenour, MD
CONTACT: Michelle Faurot, 404-778-4162
TREATMENT: Use ask, advise, refer methodology to get surgery patients to quit smoking
INCLUSION: Patients that smoke and are having surgery for cancer
EXCLUSION: Inability or reluctance to sign consent form
SPONSOR: None
PI: Ken Ogan, MD
Collaborators: Viraj Master, MD; John Pattaras, MD; Peter Nieh, MD; Fray Marshall, MD
CONTACT: Michelle Faurot, 404-778-4162
