1. TO ASSESS PREVENTION OF BONE LOSS IN WOMEN WITH LUPUS RECEIVING TREATMENT WITH GLUCOCORTICOIDS
Sponsored by: Genelabs Technologies
Purpose: The purpose of this clinical trial is to study the effects of GL701 (which contains DHEA, a mild androgenic hormone, as its active ingredient) on bone mineral density in women with active systemic lupus erythematous (SLE) who are also receiving treatment with glucocorticoids (e.g., prednisone).
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A randomized, double-blind, multi-center, placebo controlled study to assess prevention of bone loss by treatment with GL701 (Prestara[TM]) in women with systemic lupus erythematosus receiving treatment with glucocorticoids
Eligibility: Females 18 years and above.
Location and Contact Information:
Betty Quarles, Phone: 650-562-1425, Email: bquarles@genelabs.com
Kenneth Schwartz MD, Phone: 650-562-1510, Email: kschwartz@genelabs.com
2. EVALUATION OF LYME DISEASE: CLINICAL, MICROBIOLOGICAL, AND IMMUNOLOGICAL CHARACTERISTICS
This study is currently recruiting patients.
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Purpose: This study will determine whether patients who have been infected with the Lyme bacteria Borrelia burgdorferi and treated with antibiotics still have the bacteria alive inside them, and whether it is causing their symptoms.
Study Type: Observational
Study Design: Natural History
Official Title: A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients with Suspected Chronic Lyme Infection and Selected Control Populations
Eligibility: Males and females greater than or equal to 13 years old
Location and Contact Information:
Maryland
National Institute of Allergy and Infectious Diseases (NIAID)
9000 Rockville Pike, Bethesda, Maryland, 20892, United States
Patient Recruitment and Public Liaison Office
Phone: 1-800-411-1222, Email: prpl@mail.cc.nih.gov
3. OPEN LABEL STUDY OF ONTAK[TM] (DENILEUKIN DIFTITOX) IN PREVIOUSLY TREATED CUTANEOUS T-CELL LYMPHOMA PATIENTS.
Sponsored by: Ligand Pharmaceuticals
Purpose: The purpose of this study is to provide an opportunity for placebo patients from the companion 93-04-11 study to receive ONTAK. It is also designed to determine the effectiveness of ONTAK in CTCL patients whose tumors do not express CD25.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A multicenter open-label study to evaluate the safety and efficacy of DAB389IL-2 in cutaneous T-cell lymphoma (CTCL) patients following Protocol 93-04-10, Protocol 93-04-11, or Protocol 92-04-01 or who meet the requirements for Protocol 93-04-11 except have biopsy-documented CTCL that does not express CD25
Eligibility: Both genders eligible for study
Criteria * Patient must have been previously enrolled in Protocol 93-04-11 and randomized to the placebo arm; or the patient met all eligibility criteria for protocol 93-04-11 other than the expression of CD25 on CTCL tumor cells.
* CTCL disease Stage Ia-III.
* History of less than or equal to 3 previous therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic chemotherapy regimen is permitted. Topical or systemic steroids are not considered a therapy.
* Patient must have evaluable or measurable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.
* No significant pulmonary or cardiac disease. No active CNS, kidney, or liver disease.
* No systemic infections.
* ECOG performance status of 0 or 1.
Location and Contact Information:
Ligand Pharmaceuticals (Clinical Trial Sponsor) Phone Number 1-800-964-5836
4. RANDOMIZED DOUBLE-BLIND STUDY OF ONTAK[TM] (DENILEUKIN DIFTITOX) IN CUTANEOUS T-CELL LYMPHOMA (CTCL) PATIENTS.
Sponsored by: Ligand Pharmaceuticals
Purpose: The purpose of this study is to compare the effectiveness of two dose levels of ONTAK (denileukin diftitox) in treating patients who have recurrent or persistent cutaneous T-cell lymphoma.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A multicenter phase III randomized double-blind placebo-controlled study to evaluate the efficacy of two close levels of DAB389IL-2 (9 and 18 mcg/kg/day) in cutaneous T-cell lymphoma (CTCL) patients with Stage Ia-III disease who, following less than or equal to 3 previous therapies, have recurrent or persistent disease that has been biopsy-documented to express CD25
Eligibility: Both genders eligible for study
Criteria: * Histopathologically confirmed recurrent or persistent CTCL as determined by reference pathology lab.
* Patient must have had 1 to 3 prior CTCL therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic regimen is permitted. Topical or systemic steroids are not considered a therapy.
* Interleukin-2 receptor (IL-2R) expression on at least 20% of tumor cells as determined by immunohistochemistry.
* Stage IA-III disease and unlikely to progress during the first month on study. Life expectancy of at least 12 months.
* Measurable or evaluable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.
* No active CNS disease, kidney or liver disease, significant pulmonary disease, or cardiac disease.
* No systemic infections.
* Willingness to be randomized to a placebo treatment only arm.
* ECOG performance status of 0 or 1
Location and Contact Information:
Ligand Pharmaceuticals (Clinical Trial Sponsor), Phone Number 1-800-964-5836
5. INTERLEUKIN-2 IN TREATING PATIENTS WITH MYCOSIS FUNGOIDES OR SEZARY SYNDROME
Sponsored by: Robert H. Lurie Cancer Center, National Cancer Institute (NCI)
Purpose: Phase II trial to study the effectiveness of interleukin-2 in treating patients who have mycosis fungoides or Sezary syndrome.
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Study of Interleukin-2 in Patients With Mycosis Fungoides or Sezary Syndrome
Objectives: * Determine the response rate in patients with mycosis fungoides or Sezary syndrome treated with interleukin-2 (IL-2).
* Determine the toxicity of this regimen in these patients.
Outline: This is a multicenter study.
Patients receive interleukin-2 subcutaneously for 4 consecutive days a week for 6 consecutive weeks. Treatment repeats every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response or stable disease continue treatment for 2 courses past best response. Patients who demonstrate a persistent partial response continue treatment in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for survival.
Eligibility: Both genders eligible for study, 18 years and above
Criteria: * Histologically proven mycosis fungoides or Sezary syndrome
* Any stage
* Measurable disease with 1 or more indicator lesions
* Evaluable disease for erythrodermic patients only
* At least 2 weeks since prior therapy, if documented progressive disease (PD)
* At least 4 weeks since prior therapy, if best response achieved without clear evidence of PD
Location and Contact Information:
Illinois
Robert H. Lurie Comprehensive Cancer Center
Northwestern University
Chicago, Illinois, 60611-3013
United States; Recruiting
Timothy M. Kuzel, MD, Phone: 312-695-4544
Massachusetts
Boston Medical Center
Boston, Massachusetts, 02118
United States; Recruiting
Francine Marie Foss, MD, Phone: 617-638-7520, Email: ffoss@med-med1.bu.edu
6. TEMOZOLOMIDE IN TREATING PATIENTS WITH MYCOSIS FUNGOIDES OR SEZARY SYNDROME
Sponsored by: Robert H. Lurie Cancer Center, National Cancer Institute (NCI)
Purpose: Phase II trial to study the effectiveness of temozolomide in treating patients who have mycosis fungoides or Sezary syndrome that has not responded to previous treatment.
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Temozolomide in Patients With Previously Treated Mycosis Fungoides or Sezary Syndrome
Objectives: * Determine the response rate to temozolomide in patients with relapsed mycosis fungoides or Sezary syndrome.
* Determine the toxic effects of this drug in these patients.
* Correlate pretreatment AGT activity in tumor cells with response to this drug in these patients.
Outline: This is a multicenter study.
Patients receive oral temozolomide once a day on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity for a maximum of 1 year.
Patients are followed every 3 months until death.
Eligibility: Both genders eligible for study, 18 years and above
Criteria: * Histologically confirmed mycosis fungoides or Sezary syndrome
* Stage IB-IVB disease
* Must have failed at least one prior systemic therapy
* Generalized erythroderma allowed
* Measurable disease and at least one indicator lesion OR evaluable disease for erythrodermic patients only
* Prior radiotherapy to areas of measurable disease allowed if disease progression is present in the site or if measurable disease is present outside irradiation port
Location and Contact Information:
Illinois
Robert H. Lurie Comprehensive Cancer Center
Northwestern University
Chicago, Illinois, 60611-3013
United States; Recruiting
Timothy M. Kuzel, MD, Phone: 312-695-4544
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States; Recruiting
David Pezen, MD, Phone: 773-702-9200
7. CHEMOTHERAPY AND PHOTODYNAMIC THERAPY IN TREATING PATIENTS WITH CUTANEOUS T-CELL LYMPHOMA
Sponsored by: Millennix
Purpose: Randomized phase II trial to study the effectiveness of combining different doses of bexarotene with photodynamic therapy in treating patients who have stage IB or stage IIA cutaneous T-cell lymphoma.
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Randomized Study of Bexarotene and Ultraviolet A Light Therapy With Methoxsalen (PUVA) in Patients With Stage IB or IIA Cutaneous T-Cell Lymphoma
Eligibility: Both genders eligible for study, 18 years and above
Criteria: * Histologically confirmed cutaneous T-cell lymphoma within the past year
* Stage IB or IIA disease
* No prior diagnosis more advanced than stage IIA disease
Location and Contact Information:
Northwestern University Medical Center
Study chairs or principal investigators
Joan Guitart, MD, Study Chair
8. DETERMINE THE EFFECT OF ADMINISTERING PERIOSTAT[R] TWICE DAILY ON PATIENTS WITH ACNE ROSACEA
Sponsored by: CollaGenex Pharmaceuticals
Purpose: The purpose of this study is to determine whether Periostat[R], Doxycycline Hyclate 20 mg Tablets, taken twice daily is effective in reducing the red and white heads and overall redness associated with rosacea.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Determine the Effects of Doxycycline Hyclate 20 mg Tablets [Periostat[R]] Administered Twice Daily for the Treatment of Acne Rosacea
Eligibility: Both genders eligible for study, 18 years and above
9. INFLIXIMAB (REMICADE[R]) TO TREAT DERMATOMYOSITIS AND POLYMYOSITIS
Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Purpose: This study will examine whether infliximab (Remicade[R]) is safe and effective for the treatment of dermatomyositis and polymositis. Infliximab blocks the effect of a protein called tumor necrosis factor (TNF), which is associated with harmful inflammation in many diseases.
Study Type: Interventional
Study Design: Treatment, Safety/Efficacy
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial of Infliximab In Patients With Dermatomyositis and Polymyositis
Eligibility: Both genders eligible for study, 18 years and above
Location and Contact Information
Maryland
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
9000 Rockville Pike
Bethesda, Maryland, 20892
United States; Recruiting
Patient Recruitment and Public Liaison Office, Phone: 1-800-411-1222, Email: prpl@mail.cc.nih.gov
10. STUDY OF BOTULINUM TOXIN IN PATIENTS WITH PRIMARY HYPERHIDROSIS
Sponsored by: Mount Sinai Medical Center
Purpose: To determine the optimal dose of botulinum toxin necessary to decrease sweating in patients with primary hyperhidrosis.
Study Type: Interventional
Study Design: Treatment
Eligibility: Both genders eligible for study, 16 years and above
Criteria: * Diagnosis of hyperhidrosis
* Excessive sweating in the hands, feet, armpits, forehead, or body
Location and Contact Information:
New York
Mount Sinai School of Medicine
New York, New York, 10029
United States; Recruiting
Horacio Kaufmann, Phone: 212-241-7315
11. TREATMENT OF PSORIASIS WITH PARATHYROID HORMONE
Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Purpose: This is a clinical study in two phases. The first phase compares the effect of an ointment containing parathyroid hormone (PTH) with the effect of a placebo ointment (inactive ointment without PTH) on psoriasis lesions. Neither the study participants nor the researchers will know who is receiving PTH ointment and who is receiving placebo until the end of this first study phase. The second phase is a study of the PTH ointment on large areas of psoriasis to find out how long the effects last.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Evaluation of the Therapeutic Efficacy & Safety of Topical Administration of Parathyroid Hormone (PTH) in Psoriasis
Eligibility: Both genders eligible for study, 18-70 years old
Location and Contact Information
Massachusetts
Boston University School of Medicine
Boston, Massachusetts, 01843
United States; Recruiting
Sheila Decastro, Phone: 617-638-8869
Michael Holick, PhD, MD, Principal Investigator
12. TO STUDY THE EFFECTS OF CD25 AND LOW DOSE CYCLOSPORINE IN THE TREATMENT OF ACTIVE PSORIASIS VULGARIS
Sponsored by: Protein Design Labs
Purpose: This study compares the efficacy and analyzes the cellular effects of anti-TAC (Daclizumab) and Cyclosporine in the treatment of psoriasis vulgaris. This is a three-armed study-Daclizumab alone, Cyclosporine alone, and the combination of both Daclizumab and Cyclosporine.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Use of humanized CD25 (anti-TAC) monoclonal antibody and cyclosporine for the treatment of active Psoriasis.
Eligibility: Both genders eligible for study, 16 years and above
Location and Contact Information:
New York
Rockefeller University
New York, New York, 10021
United States; Recruiting
Pat Gilleaudeau, RN, MSN, FN
Phone: 212-327-8333, Email: gilleap@mail.rockefeller.edu
Mary Sullivan-Whalen, RN, MSN, FNP
Phone: 212-327-7212, Email: whalems@mail.rockefeller.edu
James Krueger, MD, PhD, Principal Investigator
13. TO STUDY THE USE OF HUMANIZED CD25 IN PREVENTING THE RELAPSE OF PSORIASIS VULGARIS
Sponsored by: Protein Design Labs
Purpose: This study is designed to study disease relapse after NBUVB and how the administration of Daclizumab/placebo alters disease relapse.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Use of Humanized CD25 (anti-TAC) Monoclonal Antibody/Placebo to Prevent Relapse of Psoriasis Vulgaris following NBUVB Therapy
Eligibility: Both genders eligible for study, 16 years and above
Location and Contact Information:
New York
Rockefeller University
New York, New York, 10021
United States; Recruiting
Pat Gilleaudeau, RN, MSN, FN
Phone: 212-327-8333, Email: gilleap@mail.rockefeller.edu
Mary Sullivan-Whalen, RN, MSN, FNP
Phone: 212-327-7212, Email: whalems@mail.rockefeller.edu
James Krueger, MD, PhD, Principal Investigator
14. DETERMINE THE EFFICACY OF TOPICAL TRETINOIN CREAM FOR THE PREVENTION OF NONMELANOMA SKIN CANCER
Sponsored by: Department of Veterans Affairs, Department of Veterans Affairs Cooperative Studies Program, Ortho Dermatologics
Purpose: Topical tretinoin has been used extensively to treat photoaged skin. Retinoids administered orally in high doses appear to be effective in chemoprevention of nonmelanoma skin cancer but have unacceptable toxicity, in this study, 900 patients with a recent history of squamous cell and/or basal cell carcinoma will be enrolled at six participating centers over a three-year period and will be randomly assigned to either 0.1% tretinoin cream or placebo. They will be followed for a minimum of three years to determine if topical tretinoin is effective in reducing the risk of new occurrences.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: VA Topical Tretinoin Chemoprevention Trial
Eligibility: Both genders eligible for study
Criteria: High risk individuals (at least 2 NMSCs in last 5 years)
15. CELECOXIB IN PREVENTING SKIN CANCER
Sponsored by: Herbert Irving Comprehensive Cancer Center, National Cancer Institute (NCI)
Purpose: Randomized phase II trial to study the effectiveness of celecoxib in preventing skin cancer in participants exposed to ultraviolet light.
Study Type: Interventional
Study Design: Prevention
Official Title: Phase II Randomized Study of Celecoxib as a Chemopreventive Agent Inhibiting Ultraviolet-Induced Erythema and Biomarkers of Cutaneous Carcinogenesis in Participants With Fitzpatrick Type I-IV Skin
Eligibility: Both genders eligible for study, 20-60 years old
Location and Contact Information:
New York
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
United States; Recruiting
David Bickers, MD, Phone: 212-305-5565, Email: drb25@columbia.edu
COPYRIGHT 2003 Journal of Drugs in Dermatology
COPYRIGHT 2003 Gale Group
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