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Generated: December 15, 2018

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CLINICAL TRIALS PROFILE FOR THALIDOMIDE

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Clinical Trials for Thalidomide

Trial ID Title Status Sponsor Phase Summary
NCT00000790 Thalidomide for Treatment of Oral and Esophageal Aphthous Ulcers and HIV Viremia in Patients With HIV Infection Completed Andrulis Pharmaceuticals Phase 2 PRIMARY: To evaluate the effectiveness and safety of thalidomide for treatment of oral and esophageal aphthous ulcers (those unrelated to a known infection or malignancy) in patients with advanced HIV disease. To evaluate the effect of thalidomide on HIV load in this patient population. Per 06/28/94 amendment, to evaluate the effectiveness of thalidomide in preventing recurrences in patients whose aphthae completely heal at the end of acute treatment. SECONDARY: To evaluate the effect of thalidomide on blood tumor necrosis factor (TNF) levels and to obtain pharmacokinetic data on the drug. Per 06/28/94 amendment, to evaluate the safety of thalidomide. Per 05/10/95 amendment, to explore in a substudy the effects of thalidomide on idiopathic genital aphthous ulcers in HIV-infected women. Aphthous ulcers of the mouth or esophagus can interfere with eating, resulting in malnutrition and wasting. Thalidomide has been proposed as an effective therapy for severe forms of aphthous ulceration in AIDS patients.
NCT00000790 Thalidomide for Treatment of Oral and Esophageal Aphthous Ulcers and HIV Viremia in Patients With HIV Infection Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 PRIMARY: To evaluate the effectiveness and safety of thalidomide for treatment of oral and esophageal aphthous ulcers (those unrelated to a known infection or malignancy) in patients with advanced HIV disease. To evaluate the effect of thalidomide on HIV load in this patient population. Per 06/28/94 amendment, to evaluate the effectiveness of thalidomide in preventing recurrences in patients whose aphthae completely heal at the end of acute treatment. SECONDARY: To evaluate the effect of thalidomide on blood tumor necrosis factor (TNF) levels and to obtain pharmacokinetic data on the drug. Per 06/28/94 amendment, to evaluate the safety of thalidomide. Per 05/10/95 amendment, to explore in a substudy the effects of thalidomide on idiopathic genital aphthous ulcers in HIV-infected women. Aphthous ulcers of the mouth or esophagus can interfere with eating, resulting in malnutrition and wasting. Thalidomide has been proposed as an effective therapy for severe forms of aphthous ulceration in AIDS patients.
NCT00000812 A Phase I, Placebo-Controlled, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Thalidomide in Subjects With HIV-1 Infection Completed Celgene Corporation Phase 1 PRIMARY: To evaluate the safety, tolerability, and pharmacokinetics of daily oral thalidomide. SECONDARY: To examine the effect of thalidomide on antiviral activity and tumor necrosis factor-alpha (TNF-alpha) production, and the correlation between TNF-alpha inhibition and viral burden. A protein in the blood called tumor necrosis factor (TNF-alpha) is abnormally elevated in patients with HIV infection and may cause the body to produce more virus. In vitro studies have demonstrated that thalidomide reduces TNF-alpha levels and inhibits production of HIV. However, more information on the pharmacological and immunological aspects of thalidomide is needed.
NCT00000812 A Phase I, Placebo-Controlled, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Thalidomide in Subjects With HIV-1 Infection Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1 PRIMARY: To evaluate the safety, tolerability, and pharmacokinetics of daily oral thalidomide. SECONDARY: To examine the effect of thalidomide on antiviral activity and tumor necrosis factor-alpha (TNF-alpha) production, and the correlation between TNF-alpha inhibition and viral burden. A protein in the blood called tumor necrosis factor (TNF-alpha) is abnormally elevated in patients with HIV infection and may cause the body to produce more virus. In vitro studies have demonstrated that thalidomide reduces TNF-alpha levels and inhibits production of HIV. However, more information on the pharmacological and immunological aspects of thalidomide is needed.
NCT00001446 A Randomized Phase II Study of Oral Thalidomide in Patients With Hormone-Refractory Prostate Cancer Completed National Cancer Institute (NCI) Phase 2 This is a phase II study designed to evaluate the potential clinical efficacy of thalidomide in patients with hormone-refractory prostate cancer. An important aspect of this study is to characterize the pharmacokinetics of thalidomide, as well as make correlations between the degree of angiogenesis occurring in a patient and the activity of thalidomide.
NCT00001475 Home Treatment of HIV-Infected Patients With Interleukin-2 With or Without a Tumor Necrosis Factor Antagonist Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 Patients enrolled in NIH protocol 95-I-0133 at the Clinical Center may participate in an extension phase of this study in which the drug prednisone will be eliminated from the treatment regimen. Prednisone is associated with avascular necrosis, a condition that has been found in a number of patients in this study. Also, certain patients in this protocol may receive future interleukin-2 treatment cycles at home. Home administration of IL-2 injections involves less frequent data and safety monitoring and no medical evaluations at the Clinical Center except at the beginning of each cycle. To be eligible for home administration of IL-2, patients must: - Be enrolled in a current NIAID protocol for IL-2 therapy and have received at least 1 year of treatment on the protocol, with at least two well-tolerated outpatient cycles at a stable dose. - Have a history of tolerable side effects while receiving IL-2 without frequent medical interventions, intravenous fluid replacement or dose reductions. - Not have had any significant clinical or laboratory abnormalities during days 0 to 5 of the last two outpatient cycles. - Have a strong relationship with a private physician or health-care provider who has been involved in the patient's care and is willing to help supervise the patient's care during each home IL-2 cycle. - Live in a home with easy telephone access and have proved reliable in responding to telephone calls from clinic staff. - Give the clinic staff contact information for a close friend or relative who will agree to serve as a caregiver during each home cycle, providing the patient non-medical assistance and checking on his or her condition daily. - Have reasonable access to emergency medical services and a nearby medical facility. - Have proved reliable and consistent in using sterile technique, reconstituting IL-2 vials and administering subcutaneous IL-2 injections. - Be receiving outpatient IL-2 injections cycles at least once every 6 months as part of their normal protocol participation. - Have access to a home weight scale and be able to weigh themselves each day for safety monitoring. Participants will receive IL-2 cycles on the same schedule they followed in their original protocol participation. They will be seen at the Clinical Center at regularly scheduled follow-up visits between cycles and for a medical evaluation and blood drawing before the start of each cycle to determine the safety of administering the cycle. During the home cycle, the patient's case manager or other team member will place monitoring telephone calls on days 2 and 4 of the cycle and again a week later. The timing and number of these calls may change depending on the findings of ongoing assessments of their usefulness. Patients will be required to notify the study team promptly of any complications or other problems that develop with therapy.
NCT00001524 Thalidomide to Treat Oral Lesions in HIV-Infected Patients Completed National Institute of Dental and Craniofacial Research (NIDCR) Phase 2 This study will test the effectiveness of topical thalidomide in healing mouth sores in HIV infected patients. Oral (PO) thalidomide heals these sores at a dose of 200 mg per day. However, PO thalidomide can cause drowsiness, skin rashes, allergic reactions, increased viral load, and even nerve damage that may not be reversible. This study will evaluate the efficacy of a topical formulation of thalidomide (placed directly on the surface of the sore) for the healing of these sores. Persons with HIV infection of acquired immunodeficiency of at least 18 years of age with one or more chronic, painful intraoral lesions may be eligible for this study. Subjects must be referred by a primary care physician who is managing their care, and must have HIV/AIDS status confirmed. Patients' HIV treatment regimen will not be altered and those receiving highly active therapy will not be excluded. Patients will be excluded if they are concurrently being treated for mucosal lesions (including topical or systemic steroids, viscous lidocaine, topical or systemic anti-fungals, or mouthwashes), or concurrent thalidomide therapy; receving chemotherapy or radiation therapy for neoplasms; using concurrent acute therapy for opportunistic infections; concurrent use of sedatives (such as CNS depressants or alcohol use); history of allergy to thalidomide; pre-existing peripheral neuropathy of grade II or higher; pregnant or lactating females or those not practicing contraception according to FDA guidelines for thalidomide.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Thalidomide

Condition Name

Condition Name for Thalidomide
Intervention Trials
Multiple Myeloma 138
Multiple Myeloma and Plasma Cell Neoplasm 19
Leukemia 9
Brain and Central Nervous System Tumors 9
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Condition MeSH

Condition MeSH for Thalidomide
Intervention Trials
Multiple Myeloma 178
Neoplasms, Plasma Cell 170
Lymphoma 27
Plasmacytoma 22
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Clinical Trial Locations for Thalidomide

Trials by Country

Trials by Country for Thalidomide
Location Trials
United States 877
China 57
Canada 46
United Kingdom 39
Italy 37
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Trials by US State

Trials by US State for Thalidomide
Location Trials
New York 75
California 41
Arkansas 41
Ohio 40
Texas 40
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Clinical Trial Progress for Thalidomide

Clinical Trial Phase

Clinical Trial Phase for Thalidomide
Clinical Trial Phase Trials
Phase 4 18
Phase 3 77
Phase 2/Phase 3 11
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Clinical Trial Status

Clinical Trial Status for Thalidomide
Clinical Trial Phase Trials
Completed 222
Recruiting 64
Unknown status 51
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Clinical Trial Sponsors for Thalidomide

Sponsor Name

Sponsor Name for Thalidomide
Sponsor Trials
National Cancer Institute (NCI) 98
Celgene Corporation 75
University of Arkansas 30
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Sponsor Type

Sponsor Type for Thalidomide
Sponsor Trials
Other 526
Industry 157
NIH 119
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Dow
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