Ongoing Clinical Protocols

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: 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; mother, sister(s), daughter(s)

• Age

• Nulliparous

• Having a first child after age 30

• Early menarche

• History of benign breast disease requiring biopsies

• LCIS or atypical hyperplasia

Sponsor: Eastern Cooperative Oncology Group

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

Cindy Rittenberg, RN 504 842–3708

Title: Protocol E1496: Randomized phase III study in low grade lymphoma comparing cyclophosphamide/fludarabine to standard therapy followed by maintenance anti-CD20 antibody.

Inclusion Criteria:

• Stage III-IV low grade non-Hodgkin's lymphoma

• Must have at least one objective measurable disease parameter

IDEC-C2B8 (rituximab) provided

Breast Cancer

Sponsor: National Surgical Adjuvant Breast and Bowel Project

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

Cindy Rittenberg, RN 504 842–3708

Title: A 3-arm randomized trial to compare adjuvant Adriamycin and cyclophosphamide followed by Taxotere; Adriamycin and Taxotere; and Adriamycin, Taxotere, and cyclophosphamide in breast cancer patients with positive axillary lymph nodes.

Inclusion Criteria:

• Tumor confined to breast and ipsilateral axilla on clinical exam (T1-3, N0-1, M0)

• At least 1 positive axillary lymph node on path exam

• Time from initial Dx to randomization < 63 days

• L VEF (MUGA or echo) > lower limit of normal

Taxotere is provided.

Hypertension

Sponsor: IntraTherapeutics

Contact: Dr. J. Stephen Jenkins 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, DBP>90 on two classes of antihypertensive medications)

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

Infectious Diseases

Sponsor: Roche Global Development

Contact: Sandra Kemmerly 504 842–4005

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

Inclusion Criteria:

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

• Seronegative for CMV pre-transplant and has received and allograft from a CMV seropositive donor

• Adequate hematological and renal function

• Able to tolerate oral medication within 10 days post-transplantation

Exclusion Criteria

• History of CMV infection

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

• Severe uncontrollable diarrhea

• Allergic adverse reaction to acyclovir, ganciclovir, or valacyclovir

Liver Transplant

Sponsor: SangStat

Contact: Dr. James Eason 504 842–5763

Dr. George Loss

Title: Randomized prospective trial using thymoglobulin induction in liver transplant recipients to eliminate steroid usage.

All adult liver transplant candidates giving informed consent.

Nephrology

Sponsor: VascA Inc.

Contact: Shannon Anderson, LPN 504 842–6526

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

Objective: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.

Study Design: Open-label, prospective, multi-center, longitudinal clinical trial. 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

Nephrology

Sponsor: R&D Laboratories

Contact: Jamie Foret, RN, BSN 504 842–6062

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

Nephrology

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 bleed 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

Rheumatology

Sponsor: Immunex Corp.

Contact: Dr. William Davis 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 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 sugical 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/cmm; white blood cell count ≥ 3,500 cells/cmm; serum creatinine ≤ 2 mg/dL

Exclusion Criteria:

• Receipt of: TNFa 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; concomitant corticosteroids > 10 mg/d (prednisone or equivalent)

• 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

Rheumatology

Sponsor: Merck & Co.

Contact: Dr. Leonard Serebro 504 842–3920

Title: A double blind randomized stratified parallel group study to access the incidence of PUBs during chronic treatment with MK-0966 or naprosyn in patients with rheumatoid arthritis: US cohort.

Inclusion Criteria: Male or female at least 50 years old having rheumatoid arthritis and in good health

Exclusion Criteria: Inflammatory arthritis, history of ulcer or GI bleed or inflammatory bowel disease, active hepatitis, stroke, allergic to acetaminophen or hypersensitive to aspirin, naproxen, or other NSAIDs.

Rheumatology

Sponsor: School of Public Health and Tropical Medicine at Tulane University Medical Center

Contact: Dr. Leonard Serebro 504 842–3920

Title: Environmental factors in the etiology of fibromyalgia in women.

Inclusion Criteria:Primary diagnosis fibromyalgia

Exclusion Criteria:No other connective tissue disease

All doctor visits, lab work, x-rays, endoscopies, and medication required for any of these particular studies are no charge to the patient.