CLINICAL TRIALS PROFILE FOR ISOTRETINOIN
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All Clinical Trials for Isotretinoin
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00000764 ↗ | Chemoprevention of Anal Neoplasia Arising Secondary to Anogenital Human Papillomavirus Infection in Persons With HIV Infection. | Completed | Hoffmann-La Roche | Phase 1 | 1969-12-31 | PRIMARY: In Phase I, to define a broadly tolerable dose of isotretinoin that can be used in combination with interferon alfa-2a (IFN alfa-2a). In Phase II, to determine trends in efficacy of isotretinoin alone or in combination with IFN alfa-2a as chemoprevention (preventing progression or recurrence) of anal intraepithelial neoplasia ( AIN ) / squamous intraepithelial lesions ( SIL ) in patients with HIV infection. SECONDARY: To evaluate the effects of isotretinoin alone or in combination with IFN alfa-2a on immune function markers, human papillomavirus (HPV) type, and HPV DNA levels. Patients with HIV infection have a significant risk of recurrence following local ablation of intraepithelial neoplasia; thus, anogenital epithelial may become an increasingly important cause of morbidity, and possibly mortality, as the HIV epidemic matures. Clinical studies of non-HIV-infected subjects have established that synthetic retinoids inhibit the progression of epithelial preneoplastic conditions and some neoplastic states. |
| NCT00000764 ↗ | Chemoprevention of Anal Neoplasia Arising Secondary to Anogenital Human Papillomavirus Infection in Persons With HIV Infection. | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 1 | 1969-12-31 | PRIMARY: In Phase I, to define a broadly tolerable dose of isotretinoin that can be used in combination with interferon alfa-2a (IFN alfa-2a). In Phase II, to determine trends in efficacy of isotretinoin alone or in combination with IFN alfa-2a as chemoprevention (preventing progression or recurrence) of anal intraepithelial neoplasia ( AIN ) / squamous intraepithelial lesions ( SIL ) in patients with HIV infection. SECONDARY: To evaluate the effects of isotretinoin alone or in combination with IFN alfa-2a on immune function markers, human papillomavirus (HPV) type, and HPV DNA levels. Patients with HIV infection have a significant risk of recurrence following local ablation of intraepithelial neoplasia; thus, anogenital epithelial may become an increasingly important cause of morbidity, and possibly mortality, as the HIV epidemic matures. Clinical studies of non-HIV-infected subjects have established that synthetic retinoids inhibit the progression of epithelial preneoplastic conditions and some neoplastic states. |
| NCT00001073 ↗ | Safety and Effectiveness of Giving Isotretinoin to HIV-Infected Women to Treat Cervical Tumors | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 3 | 1969-12-31 | The purpose of this study is to see if it is safe and effective to give isotretinoin to HIV-infected women with cervical tumors to prevent these tumors from becoming cancerous. Cervical tumors are found in both HIV-infected and HIV-negative women. However, HIV-infected women are at a greater risk, and often their tumors become cancerous more quickly than those in HIV-negative women. Isotretinoin may be able to prevent this from happening. However, since these tumors tend to disappear over time, many doctors are hesitant to give their patients isotretinoin since this drug causes birth defects. This study looks at whether it is better to treat cervical tumors in HIV-infected women or to wait and see if they will disappear by themselves. |
| NCT00002506 ↗ | Isotretinoin Plus Interferon in Treating Patients With Recurrent Cancer | Completed | Cancer Biotherapy Research Group | Phase 2 | 1992-08-01 | RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of isotretinoin may be an effective way to prevent cancer or stop cancer from growing. Interferon alfa may interfere with the growth of cancer cells. Combining isotretinoin and interferon may be an effective treatment for some recurrent cancers. PURPOSE: Phase II trial to study the effectiveness of interferon alfa plus isotretinoin in treating patients with recurrent cancer. |
| NCT00002506 ↗ | Isotretinoin Plus Interferon in Treating Patients With Recurrent Cancer | Completed | Hoag Memorial Hospital Presbyterian | Phase 2 | 1992-08-01 | RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of isotretinoin may be an effective way to prevent cancer or stop cancer from growing. Interferon alfa may interfere with the growth of cancer cells. Combining isotretinoin and interferon may be an effective treatment for some recurrent cancers. PURPOSE: Phase II trial to study the effectiveness of interferon alfa plus isotretinoin in treating patients with recurrent cancer. |
| NCT00002737 ↗ | Interferon Alfa With or Without Isotretinoin in Treating Patients With Metastatic Kidney Cancer | Completed | European Organisation for Research and Treatment of Cancer - EORTC | Phase 3 | 1996-03-01 | RATIONALE: Interferon alfa may interfere with the growth of the cancer cells and slow the growth of kidney cancer. Isotretinoin may help kidney cancer cells develop into normal cells. It is not yet known whether interferon alfa plus isotretinoin is more effective than interferon alfa alone for kidney cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without isotretinoin in treating patients who have metastatic kidney cancer. |
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