Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase I/II Study of Intratumoral Injection of Ipilimumab in Combination With Local Radiation in Melanoma, Non-Hodkgkin Lymphoma and Colorectal Carcinoma
This pilot phase 1-2 trial studies the side effects and best of dose ipilimumab when given together with local radiation therapy and to see how well it works in treating patients with recurrent melanoma, non-Hodgkin lymphoma, colon, or rectal cancer. Monoclonal antibodies, such as ipilimumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiation therapy uses high energy x rays to kill cancer cells. Giving monoclonal antibody therapy together with radiation therapy may be an effective treatment for melanoma, non-Hodgkin lymphoma, colon, or rectal cancer. - The phase 1 component ("safety") of this study is ipilimumab 25 mg monotherapy. - The phase 2 component ("treatment-escalation") of this study is ipilimumab 25 mg plus radiation combination therapy.
PRIMARY OBJECTIVES: 1. To assess the safety of combining intratumoral anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) immunotherapy with local radiation therapy in patients with melanoma, non-Hodgkin lymphoma, and colorectal carcinoma with a monotherapy ipilimumab safety lead-in. SECONDARY OBJECTIVES: 1. To assess the induction of an anti-tumor immune responses using laboratory correlative studies. 2. To determine tumor response rates and duration of response at unirradiated tumor sites in patients with advanced malignancies. 3. To identify putative immunologic biomarkers of tumor response. OUTLINE: This is a phase I safety study of ipilimumab monotherapy, followed by a phase 2 study. Only a few subjects participated in the phase 1 portion of this study. The phase 2 treatment-escalation portion of this study (ipilimumab plus radiation combination therapy) was not conducted. Patients receive ipilimumab intratumorally on day 1 and undergo local radiation therapy within 48 hours for at least 3 fractions. After completion of study treatment, patients are followed up at 4 and 8 weeks, and then every 24 weeks for 5 years. ;
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|---|---|---|---|
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