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Phase II Study Of Roferon and Accutane For Patients With T-Cell Malignancies



Phase II Study Of Roferon and Accutane For Patients With T-Cell Malignancies

For Condition: Mycosis Fungoides,Lymphoma, T-Cell,Hematologic Neoplasms
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center ,
Synopsis: 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).
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: - Histologic proof of incurable T-Cell malignancy and not eligible for existing higher priority protocols. - Patients should not have received chmoe, immuno, hormonal, or radiation therapy within 3 weeks of entry into this study and must have recovered from acute toxic effects of prior therapy. - Life expectancy of at least 12 weeks and a ZUBROD status of /= 18 years of age. - No other current chemo, immuno, or radiotherapy allowed. - Bilirubin Total Enrollment: 60

Location and Contact Information:

M. D. Anderson Cancer Center *Recruiting*
Houston,  Texas,  77030
United States
Recruiting Susan  Pilat 713-745-3296


Additional Information:
Study ID Numbers:
  DM90-007; 
Study Start Date: May 1990
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00038376

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