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| Tracking Information | |||||
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| First Received Date ICMJE | May 30, 2002 | ||||
| Last Updated Date | March 12, 2009 | ||||
| Start Date ICMJE | May 1990 | ||||
| Primary Completion Date | June 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To determine if the drug combination of alpha-interferon and isotretinoin is effective in controlling T-cell malignancies. [ Time Frame: 15 Years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00038376 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Phase II Study Of Roferon and Accutane For Patients With T-Cell Malignancies | ||||
| Official Title ICMJE | Phase II Study of Interferon Alpha and Isotretinoin in Patients With T-Cell Malignancies | ||||
| Brief Summary | The purpose of this study is to determine the response rate of patients with T-cell malignancies to combination therapy using interferon-alpha (Roferon) and Isotretinoin (Accutane). |
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| Detailed Description | Retinoids have shown activity in T-cell malignancies in past studies (both isotretinoin and etretinate) with an overall response rate of about 60%. One third of those responses were complete responses. Interferon-alpha has proven efficacy in wide ranges of human malignancies including T-cell lymphomas as a single agent. A clinical trial was needed to evaluate the response rate of these two agents combined. Interferon is a normal body protein, which is made by cells after exposure to viruses. It acts as a messenger to warn surrounding cells of invasions by viruses and, possibly, by cancer cells. Isotretinoin is a synthetic form of Vitamin A which effects the growth of normal cells and cancer cells. Participants participating in this study will receive a combination of alpha-interferon and isotretinoin. Alpha-interferon will be given once a day for an initial period of 12 weeks. Participants will take the drug home, where a nurse or family member of the participant (who can be trained at UTMDACC) will inject it just under the skin (SQ). Isotretinoin will be given by mouth twice a day. If a participant's disease does not show a response, the alpha-interferon and the isotretinoin will be increased. If side effects occur, the dose of alpha-interferon and/or isotretinoin will be decreased by 50%. If the side effects are severe, therapy will be discontinued. If the participant's disease is unresponsive or worsens, the participant will be taken off study and other treatments will be recommended. Responding participants will be placed on a maintenance schedule for as long as they respond. Up to 60 participants will be studied at UT M.D. Anderson Cancer Center to test the effectiveness of this drug combination. This is an investigational study. Alpha-interferon and isotretinoin are FDA approved and commercially available. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | Experimental: Alpha-interferon + Isotretinoin | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Completion Date | June 2005 | ||||
| Primary Completion Date | June 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: 1) Pediatric Patients under 18 years old. |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00038376 | ||||
| Responsible Party | Razelle Kurzrock, MD, BS/Professor, UT MD Anderson Cancer Center | ||||
| Study ID Numbers ICMJE | DM90-007 | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | March 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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