Bone Metastases Other Than Breast or Prostate Cancer or Multiple Myeloma
Sponsor: Schering-Plough Research Institute
Contact: Cindy Rittenberg, RN 504 842-3708
Title: Protocol CGP-4244603-011: A randomized, double-blind, placebo-controlled, multicenter trial to evaluate the safety and efficacy of Zoledronate (4 and 8 mg) administered intravenously as an adjuvant to anticancer therapy to patients with any cancer with bone metastases other than breast cancer, multiple myeloma, or prostate cancer.
Inclusion Criteria:
Diagnosis of cancer other than breast, prostate, or multiple myeloma
Objective evidence of metastatic bone disease within 6 weeks of trial entry
No previous treatment with a biphosphonate
Study Design: Patients are randomized to receive by rapid iv infusion Zoledronate 4 mg, Zoledronate 8 mg, or placebo. Patients may receive concomitant standard anti-neoplastic radiation or cytokine colony stimulating therapy.
Breast Cancer Prevention
Sponsor: Eastern Cooperative Oncology Group
Contact: Carl G. Kardinal, MD 504 842-3708
Chris D'Arcangelo, 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 Prevention
Sponsor: National Surgical Adjuvant Breast and Bowel Project
Contact: Carl G. Kardinal, MD
Kate Rodger, RN 504 842-3708
Title: Study of tamoxifen 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
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.
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.
Inclusion Criteria: All adult liver transplant candidates giving informed consent.
Melanoma
Sponsor: Sunbelt Melanoma Trial (Cooperative Group of Surgical Oncologists)
Contact: George Fuhrman, MD 504 842-4070
Cindy Rittenberg, RN504 842-3708
Title: Sunbelt Melanoma Trial (SMT): A multicenter trial of adjuvant interferon ALFA-2b for melanoma patients with early lymph node metastasis detected by lymphatic mapping and sentinel lymph node biopsy.
Inclusion Criteria:
Patients with melanoma > 0.76 mm thick or Clark's level III invasion and clinically negative nodes
The primary cutaneous melanoma must be on the head, neck, trunk, extremity, palm of hand, or sole of foot
Patients must be between the ages of 18 and 70
Patients cannot have a wide skin excision prior to randomization and treatment
Myelodysplastic Syndrome
Sponsor: Eastern Cooperative Oncology Group
Contact: Chris D'Arcangelo, RN 504 842-3708
Title: E 1996: Phase III evaluation of EPO with or without G-CSF versus supportive therapy alone in the treatment of myelodysplastic syndromes.
Inclusion Criteria:
Myelodysplastic syndrome RA, RA-S, or RAEB as defined by the FAB as cooperative groups
No androgens or steroids within 2 weeks prior to starting treatment
Non-Hodgkin's Lymphoma
Sponsor: Eastern Cooperative Oncology Group
Contact: Carl G. Kardinal, MD 504 842-3708
Chris D'Arcangelo, RN 504 842-3708
Title: Protocol E4492: Phase III trial of CHOP versus CHOP and chimeric anti-CD-20 monoclonal antibody (IDEC-C2B8) in patients 60 years or older with diffuse mixed, diffuse large cell, and immunoblastic large cell histology non-Hodgkin's lymphoma.
Inclusion Criteria:
Intermediate or high grade non-Hodgkin's lymphoma, B-cell, positive CD20 and/or CD9
At least one measurable disease parameter
No prior treatment except corticosteroids
Pretreatment IgG level greater than 500 mg/dL
IDEC-C2B8 (Rituximab) provided
Ovarian Cancer
Sponsor: Schering-Plough Research
Contact: Richard Kline, MD 504 842-3708
Cindy Rittenberg, RN 504 842-3708
Title: Protocol C98-102: A phase II/III trial of chemotherapy alone versus chemotherapy plus SCH 58500 in newly diagnosed stage III ovarian and primary peritoneal cancer patients with <2 cm residual disease (0–2 cm) following surgery.
Inclusion Criteria:
Stage III epithelial, ovarian, or primary peritoneal cancer
Residual disease > 0.5 cm and < 2 cm following cytoreductive surgery
Mutant or null p53 gene
Serologically positive for anti-adenovirus antibodies at screening
Study Design: Patient is randomized to receive Taxol/Carbo plus SCH 58500 for cycles 2 through 6 of chemotherapy.
Pancreatic Cancer
Sponsor: SuperGen
Contact: Edwin A. McElroy, Jr., MD 504 842-3708
Cindy Rittenberg, RN 504 842-3708
Title: Protocol RFS 2000-02: Phase III randomized study of RFS 2000 (9-nitro-camptothecin, RFS 2000) versus gemcitabine HCL in chemonaive pancreatic cancer patients.
Inclusion Criteria:
KPS > 50
Chemotherapy naïve
Pancreatic Cancer
Sponsor: SuperGen
Contact: Cindy Rittenberg, RN 504 842-3708
Title: Protocol RFS 2000-09: Phase III study of RFS 2000 (9-nitrocamptothecin, 9-NC) versus most appropriate chemotherapy in refractory pancreatic cancer patients.
Inclusion Criteria:
Patients must have failed or relapsed after receiving at least one prior chemotherapy regimen (other than gemcitabine or 5-FU as a radiation sensitizer as their only chemotherapy)
Study Design: Patients are randomized to receive oral RFS 2000 given daily x5 followed by a 2-day rest, or to the most appropriate chemotherapy available.
Pancreatic Cancer
Sponsor: SuperGen
Contact: Edwin A. McElroy, Jr., MD 504 842-3708
Cindy Rittenberg, RN 504 842-3708
Title: Protocol RFS 2000-06: Phase III randomized study of RFS 2000 (9-nitrocamptothecin, 9-NC) versus 5-fluorouracil (5-FU) in pancreatic cancer patients that have progressive disease following gemcitabine HCL treatment.
Inclusion Criteria:
KPS > 50
Must have received gemcitabine and have progressive disease during or following treatment
Cannot have received any other chemotherapy except gemcitabine
Study Design: Patients will be randomized to either oral RFS 2000 given daily x5 followed by a 2-day rest, or to iv 5-FU given weekly.
Rheumatology
Sponsor: Immunex Corporation
Contact: Dr. William E. Davis 504 842-3920
Title: Immunex protocol 16.0012 – recombinant human tumor necrosis factor receptor fusion protein (TNFR:Fc) vs. methotrexate in rheumatoid arthritis.
Inclusion Criteria:
Active early RA as duration of disease = 3 years (36 months)
No prior treatment with methotrexate
Exclusion Criteria:
Intra-articular, soft tissue, or intra-muscular corticosteroid injection during 4 weeks prior to screening
Treatment with cyclophosphamide within 6 months prior to screening
Presence of anti-DNA antibodies at screening or history of anti-cardiolipin antibodies associated with a thrombotic event or recurrent fetal loss syndrome
Rheumatology
Sponsor: University of Connecticut Health Center
Contact: Dr. Robert Quinet 504 842-3920
Title: The national woman arthritis study.
Inclusion Criteria: Women 18–64 with no life-threatening illnesses: cancer, heart disease
Patient paid $100 the first year for participation – a yearly phone interview
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: Merck & Co.
Contact: Dr. Robert Quinet 504 842-3920
Title: A randomized multi-center study to evaluate the tolerability and effectiveness of rofecoxib (MK-0966) 25 mg q.d. vs. naproxen 500 mg b.i.d. in patients with osteoarthritis.
Inclusion Criteria:
At least 40 years of age
Osteoarthritis in knee, hip, or spine for >6 months
History of therapeutic benefit in OA of the knee, hip, hand, or spine with NSAID or acetaminophen use
Exclusion Criteria:
Diagnosed as American College of Rheumatology Functional Class 4
Concurrent medical or arthritic disease that could confound or interfere with evaluation of efficacy including inflammatory arthritis
History of GI malabsorption
Allergic to naproxen, acetaminophen or hypersensitive to aspirin, ibuprofen, naproxen, or other NSAIDs
Rheumatology
Sponsor: Searle & Co.
Contact: Dr. Robert J. Quinet & Dr. Leonard Serebro 504 842-3920
Title: Clinical protocol for a multi-center double blind parallel group study comparing the incidence of clinically significant upper gastrointestinal adverse events associated with SC-58635, 400 mg b.i.d. to that of diclofenac 75 mg b.i.d. in patients with osteoarthritis or rheumatoid arthritis, IND 48395. The Celecoxib long-term arthritis safety study (class 2).
Inclusion Criteria:
Legal age of consent
Documented clinical diagnosis of OA or RA of at least 3 months duration as chronic NSAID therapy
Exclusion Criteria:
Active malignancy of any type or history of a malignancy
Diagnosed and treated for esophageal gastric pyloric channel or duodenal ulceration within 30 days prior to the first dose
Active GI disease
History of gastric or duodenal surgery or any renal or hepatic dysfunction
Abnormal screening/laboratory abnormality
Known hypersensitivity to Cox-2 inhibitors, sulfonamides, or Diclofenac
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.
- Ochsner Clinic and Alton Ochsner Medical Foundation
