Ongoing Clinical Protocols at Ochsner

Breast Cancer

Sponsor: National Surgical Adjuvant Breast and Bowel Project

Contact: Carl G. Kardinal, MD 504 842-3708

Kate Roger, RN 504 842-3708

Title: NSABP B-31: A randomized trial comparing the safety and efficacy of adriamycin and cyclophosphamide followed by taxol (T+h) to that of adriamycin and cyclophosphamide followed by taxol plus herceptin (T+H) in node-positive breast cancer patients who have tumors that over-express HER2.

Study Design: This study, involving 2700 patients, will be conducted in two stages. The primary aim of the first stage is to evaluate cardiac safety and determine the toxicities of adding weekly Herceptin to four cycles of adjuvant Taxol after completion of four cycles of Adriamycin and cyclophosphamide, with or without 5 years of treatment with tamoxifen. Provided that the incidence of cardiac toxicity in the study arm falls within the boundaries set by the protocol, the study will proceed to the second stage, which is to evaluate the efficacy of adding Herceptin to chemotherapy in prolonging survival. The Herceptin will be given weekly for one year.

Inclusion Criteria: Eligible patients must have invasive adenocarcinoma of the breast that is confined to the breast and ipsilateral axilla on clinical exam; patients must also have at least one axillary lymph node that is positive on routine histologic examination. atients must have had either: 1) a mastectomy and axillary dissection, or 2) lumpectomy with tumor-free margins and axillary dissection. ER/PgR may be positive or negative. Must have normal LVEF.

Exclusion Criteria: Patients with known sensitivity to benzyl alcohol are ineligible. Patients with sensory/motor neuropathy >grade 2, as defined by NCI's Common Toxicity Criteria, are ineligible. Inadequate hepatic function reflected in lab values unless investigator determines them to be clinically unremarkable.

Breast Cancer (STAR Trial)

Sponsor: National Surgical Adjuvant Breast and Bowel Project

Contact: Carl G. Kardinal, MD 504 842-3708

Kate Roger, RN 504 842-3708

Title: Study of Tamoxifin and Raloxifene for the prevention of breast cancer.

Inclusion Criteria: Postmenopausal women age 35 or older. Must be risk eligible determined by the Gail Model: family history of breast cancer; age; nulliparous; having a first child after age 30; early menarche; history of benign breast disease requiring biopsies; LCIS or atypical hyperplasia.

CMV Prevention in Transplants

Sponsor: Roche Global Development

Contact: Sandra Kemmerly, MD 504 842-4005

Title: A randomized, double-blind, double-dummy, active-comparator-controlled, multicenter study of the efficacy and safety of valganciclovir (Ro 107-9070) vs. oral ganciclovir for prevention of cytomegalovirus disease in high-risk heart, liver, and kidney allograft recipients (Protocol PV16000).

Inclusion Criteria:

• Has received first heart, liver, kidney, or kidney-pancreas allograft

• Seronegative for CMV pretransplant and has received an allograft from a CMV-seropositive donor

• Adequate hematological and renal function

• Able to tolerate oral medication within 10 days posttransplantation

Exclusion Criteria:

• History of CMV infection

• Has received anti-CMV therapy in the past 30 days

• Allergic adverse reaction to acyclovir, ganciclovir, or valacyclovir

Chronic Renal Failure

Sponsor: Shire Laboratories

Contact: Shannon Anderson, LPN 504 842-6526

Title: An open label, randomized, multicenter, phase III, comparator-controlled parallel group study to assess the long-term safety and efficacy of lanthanum carbonate in chronic renal failure patients receiving hemodialysis.

Objective: Safety in chronic renal failure patients with hyperphosphatemia on hemodialysis will be evaluated by monitoring biochemical and hematological parameters, adverse events, vital signs, physical examination, and psychometric assessments.

Inclusion Criteria:

• > 12 years of age and able to give written informed consent prior to beginning specific protocol procedures (patient or guardian)

• Initiative and means to be compliant with the protocol

• Received hemodialysis for chronic renal failure 3 times per week for at least the previous 2 months

Exclusion Criteria:

• Pregnant or lactating

• Does not agree to use effective birth-control methods

• Hypocalcemia at screening

• Clinically significant abnormal laboratory values at screening (excluding markers of pathologies associated with chronic renal failure)

• Clinically significant, uncontrolled, concurrent illness, which would impair patient ability to give informed consent or take part in this clinical study

• Any significant gastrointestinal surgery or gastrointestinal disorders including GI bleeding within last 6 months, Crohn's disease or other conditions where the integrity of the GI tract may be compromised, uncontrolled peptic ulcer, past (treated within past 5 years) or present GI malignancy

• Elevated serum transaminases (ALT or AST) > 3 times the upper limit of normal

• Life threatening malignancy or current multiple myeloma

• HIV positive

• Exposure to an experimental drug within 30 days prior to screening

• Treated with any phosphate binder after the washout period prior to randomization

Diabetes

Sponsor: Pfizer

Contact: Marilyn Carleton 504 842‐2811

Title: Efficacy and safety of inhaled human insulin therapy in subjects with type 2 diabetes mellitus not optimally controlled with diet and exercise: a 3‐month, outpatient, parallel comparative trial.

Inclusion Criteria:

• Diagnosed type 2 (adult onset) diabetes at least 2 months

• On diet & exercise only as diabetic treatment

• Age 35‐80

• Nonsmoker for at least 6 months

• Willing to perform blood glucose testing at home

Exclusion Criteria:

• Respiratory disease, major organ system disease, or cancer within past 5 years

• Use of glucocorticoids

• Body Mass Index >40

A home glucose meter & supplies are supplied during the study period.

Ochsner Clinic is the only site in the area currently conducting inhaled insulin studies using experimental powdered form insulin with a device similar to an asthma inhaler for treating type 2 diabetes. Subjects who successfully complete this 3‐month trial will be eligible to receive Inhaled Insulin treatment in a long‐term, open‐label trial.

Erectile Dysfunction

Sponsor: Bayer Corporation

Contact: Harold A. Fuselier, MD 504 842-4083

Title: A randomized, double-blind, placebo-controlled, multicenter, fixed-dose, parallel group, 6-month comparison study to investigate the efficacy and safety of the Phosphodiesterase Type V Inhibitor Bay 38-9456 in males with erectile dysfunction (IND #57,703).

Inclusion Criteria: Males with ED for more than 6 months;stable, heterosexual relationship; age range 18 years or older

Exclusion Criteria:

• Medical Conditions: Penile anatomical abnormalities; primary hypoactive sexual desire; ED after spinal cord injury; history of radical prostatectomy; retinitis pigmentosa; hepatitis B or C; chronic heart, hematological, or liver disease; unstable angina pectoris; history of MI, stroke, EKG ischemia or arrhythmia within 6 months; PUD within 1 year; resting systolic B/P <90 mmHg or resting systolic B/P >170 mmHg or a resting diastolic B/P >110 mmHg; uncontrolled diabetes mellitus, hyperthyroidism or hypothyroidism; severe migraine headaches; history of malignancy < 5 years (except prostate cancer or squamous or basal cell skin cancer)

• Concomitant Meds:Nitrates, antiandrogens, ketoconazole, erythromycin, or rifampin; anticoagulants, except for antiplatelet agents; androgens or trazodone; Viagra® or other therapy for ED within 7 days of visit 1; HIV protease inhibitors

• Abnormal Lab Values: Total testosterone <285 ng/dL; LFT and creatinine, 3 times upper limit of normal and 2.5 mg/dL, respectively

• Other: Viagra® failures

All office visits, laboratory tests, x-rays, EKGs, study medication, and parking fees are provided at no charge to the patient.

Hemodialysis

Sponsor: R&D Laboratories

Contact: Jamie Foret, RN, BSN504 842-6062

Title: Crossover, randomized, blinded, prospective, multicenter clinical evaluation of the rate of adverse events to Ferrlecit®in hemodialysis patients as compared to placebo and historical controls; Protocol: FER9803.

Objective: To compare events defined as Outcomes Adverse Events (Outcomes AEs), Life-threatening Adverse Events (LAEs) after Ferrlecit® administration to two controls: (1) Outcome AE and LAEs after placebo; (2) to the same defined events identified from an historical control after iron dextran administration. To compare the incidence of all allergic reactions (as defined in sections 13.2) following Ferrlecit® administration and those following placebo administration. To assess the safety of administration of Ferrlecit® at a rate of 12.5 mg/min (the rate generally used in Europe).

Study Design: Study of the safety of sodium ferric gluconate complex in sucrose infection (Ferrlecit®) in iron deficient, anemic, hemodialysis patients versus two controls-placebo and an historical control rate identified from a meta-analysis of publications describing rates of events from iron dextran.

Inclusion Criteria:

• Adult hemodialysis patient who can provide written informed consent

• On supplemental erythropoietin therapy for > 120 days

• Physician-identified need for at least 125 mg of elemental intravenous iron as defined by:

  • Hematocrit < 36% or hemoglobin < 12.5 gm/dL; serum apoferritin < 800 ng/mL and transferrin saturation <50% (values should be obtained within the week preceding HD#2)

  • Chronic hemodialysis for > 120 days for a diagnosis of End Stage Renal Disease

Exclusion Criteria:

• Prior treatment with Ferrlecit

• Known sensitivity to benzyl alcohol

• First use of a dialyzer membrane

• Acute or chronic therapy with antihistamines or corticosteroids

• Clinical instability defined as: Dialysis for fluid removal at a rate of > 1 L/hour; Kt/V < 1.2 or URR < 65%; serum albumin < 3.0 gm/dL; history of repeated missed dialysis sessions; unstable angina; history or symptoms of cerebral vascular insufficiency; inability to achieve normal oxygen saturation; blood sugar > 400 mg/dL or < 50 mg/dL in preceding 2 weeks; hospitalization within 30 days of HD session #1 (except for vascular access repair)

• Use of an Investigational Agent within 7 days of HD session #1

Hemodialysis

Sponsor: VascA Inc.

Contact: Shannon Anderson, LPN 504 842-6526

Title: VascA LifeSite™ Hemodialysis Access System, an extended investigation; Protocol # TF 0400 Extension.

Study Design Open-label, prospective, multicenter, longitudinal clinical trial to evaluate the safety and efficacy of the VascA LifeSite™ device (a cannula and a subcutaneous valve with a needle actuated pinch clamp) as defined by the ability to provide blood access during hemodialysis. Data will be collected (3 times per week) at baseline, during implant, at initiation (Week 0), Week 2, Week 4, and at 1-month intervals for up to 12 months and quarterly thereafter for the life of the device.

Inclusion Criteria: (All inclusion and exclusion criteria must be met for a subject to be eligible for enrollment.)

• Requires immediate vascular access for hemodialysis while awaiting maturation or surgical creation of a permanent AV fistula or graft

• > 18 years old

• Has a history of compliance with a dialysis treatment schedule or, if a new patient, expresses a willingness to be compliant with the treatment schedule

• Plans to continue hemodialysis treatment and follow-up at the investigational site

• Must be able to care for the exit site independently or have someone who is able to care for the site for them

• Must sign the informed consent document

Exclusion Criteria:

• A patient having had any infection associated with one or more positive blood cultures is not eligible until 14 days after blood cultures have become negative and clinical resolution of the episode has occurred

• Systemic or localized infection that is unresponsive to antibiotic therapy and/or is life threatening

• Any infection associated with the implantation site

• Local tissue factors that will prevent proper device stabilization and/or access (e.g., lack of adequate subcutaneous tissue to stabilize the valve or cannula)

• Known or suspected allergy to the device materials (titanium alloy, stainless steel, or silicone)

• Pregnant

• Known intravenous drug abuser

Macular Degeneration

Sponsor: University of Pennsylvania Health System

Contact: Laurence Arend, MD 504 842-3995

Nancy Plater, COA 504 842-4706

Title: Radiation of age-related macular degeneration study.

Inclusion Criteria:

• 40 years of age

• Angiographic evidence of classic, occult, or mixed CNV

• Blood, if any, obscures <50% of total lesion in the study eye

• Visual acuity > 20/320 in the study eye

Exclusion Criteria:

• Signs of other diseases causing CNV in the study eye, such as ocular histoplasmosis, high myopia, or angioid streaks

• Previous chemotherapy, diabetes, or periorbital or ocular radiation

Male Pattern Hair Loss

Sponsor: Merck and Co.

Contact: Aura Cole 504 842-4744

Title: A double-blind, placebo-controlled multicenter study to determine the effect of finasteride in men with advanced male pattern hair loss.

Study Design: 2-year study to determine the effect of 1 mg of finasteride on advanced male pattern hair loss.

Inclusion Criteria:

• Healthy male 18-41 years of age

• Advanced hair loss (extensive frontal or overall)

• Willing to maintain the same hair style and use same hair products for length of study

Exclusion Criteria:

• History of previous treatment with any other investigational drug(s) 3 months prior to beginning study

• History of treatment with (finasteride) Proscar or Propecia, or any other five alpha reductase inhibitors (i.e. saw palmetto)

• Scalp hair loss due to reasons other than androgenic alopecia

Prostate Cancer

Sponsor: Barr Laboratories, Inc.

Contact: Harold A. Fuselier, MD 504 842-4083

Title: A phase III, randomized, multicenter, placebo-controlled, double blind clinical trial to study the efficacy and safety of CyPat® cyproterone acetate for the treatment of hot flashes following surgical or chemical castration of prostate cancer patients and its impact on the quality of life in these patients.

Inclusion Criteria: >18 years of age; bilateral orchiectomy or using an LHRH agonist; bothersome hot flashes (defined as 3-4 moderate to severe per day or 30 per week) present for at least 1 month prior to study entry; ECOG score between 0-1; life expectancy >12 months

Exclusion Criteria: Any of the following therapies require a 4-week washout: antineoplastic/cytotoxic agents, estrogens, antiandrogens, progestational agents, corticosteroids, clonidine, monoamine oxidase inhibitors; uncontrolled diabetes mellitus; known cardiovascular risks; thromboembolic disease; hepatic and/or renal dysfunction; other malignancy in the last 5 years

All office visits, laboratory tests, study medication, and parking fees are provided at no charge to patients.

Renovascular Hypertension Stent

Sponsor: IntraTherapeutics

Contact: J. Stephen Jenkins, MD 504 842‐3724

Title: Clinical study protocol of the ITI renal stent for the treatment of renovascular hypertension.

Inclusion Criteria: At least a 70% stenosis of a renal artery, severe renovascular hypertension (SBP>140 mmHg, DBP>90 mmHg on two classes of antihypertensive medications)

Exclusion Criteria: Renal artery <4mm or >8mm, creatinine >3.0 mg/dL, kidney length <7cm, contraindication to antiplatelet therapy, pregnant females, acute intraluminal thrombus of proposed lesion, previous ipsilateral bypass of the renal artery under consideration, pt. has only one kidney, previous kidney transplant, abdominal aortic aneurysm >5cm.

Rheumatoid Arthritis

Sponsor: Immunex Corp.

Contact: William Davis, MD 504 842-3920

Title: Immunex Protocol 16.0029: double-blind, randomized, placebo-controlled study of Enbrel® (etancerept) in the treatment of rheumatoid arthritis subjects with comorbid disorders (Immunex Corp.).

Inclusion Criteria:

• Adults (at least 18 years of age) capable of giving informed consent who: fulfill 1987 American Rheumatism Association criteria for RA, may benefit from Enbrel®, and are able to self-inject study drug (or have designee who can do so)

• Documented comorbidity including one of the following: diabetes mellitus requiring insulin or oral hypoglycemic agents; chronic pulmonary disease; pnuemonia in the last year; recurrent bronchitis, sinusitus, or UTI (2 or more episodes in the last year)

• Heterosexually active men and women and of childbearing potential agreeing to use medically accepted form of contraception throughout study and follow-up period

• Negative serum pregnancy test in all women (except those sugically sterile or at least 5 years menopausal

• SGOT, SGPT < two times laboratory's upper limit of normal; hemoglobin > 8.5 g/dL; platelet count > 125,000/cu mm; white blood cell count > 3,500 cells/cu mm; serum creatinine < 2 mg/dL

Exclusion Criteria:

• Receipt of: TNFα antibody or experimental metalloproteinase inhibitors (except minocycline or doxtclycline); investigational drugs or biologics within 4 weeks of screening; anti-CD4 or diptheria IL-2 fusion protein within the previous 6 months with a subsequent abnormal absolute T cell count; introarticular corticosteroids during the 2 weeks prior to screening; cyclosporine, thalidomide, or azathioprine within 4 weeks or cyclophosphamide within 6 months before the first dose of the study drug; NSAID dose greater than the maximum recommended in product information; concomtitant corticosteroids > 10 mg/d (prednisone or equivilant)

• Pregnant breast-feeding females

• Significant concurrent medical diseases including: serious infection, open cutaneous ulcers,concurrent antibiotic treatment, MI in past year, angina pectoris, uncontrolled hypertension, severe pulmonary disease, history of cancer (other than resected cutaneous basal and squamous cell carcinoma, or in situ cervical cancer) within 5 years, HIV positive, connective tissue disease other than RA

• Current or history of psychiatric disease or alcohol or drug abuse that could interfere with study compliance