Ipilimumab and Local Radiation Therapy in Treating Patients With Recurrent Melanoma, Non-Hodgkin Lymphoma, Colon, or Rectal Cancer
|Adult Nasal Type Extranodal NK/T-cell Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Cutaneous B-cell Non-Hodgkin Lymphoma Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Hepatosplenic T-cell Lymphoma Intraocular Lymphoma Nodal Marginal Zone B-cell Lymphoma Peripheral T-cell Lymphoma Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Grade III Lymphomatoid Granulomatosis Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Adult T-cell Leukemia/Lymphoma Recurrent Colon Cancer Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Melanoma Recurrent Mycosis Fungoides/Sezary Syndrome Recurrent Rectal Cancer Recurrent Small Lymphocytic Lymphoma Refractory Hairy Cell Leukemia Small Intestine Lymphoma Splenic Marginal Zone Lymphoma T-cell Large Granular Lymphocyte Leukemia Testicular Lymphoma Waldenström Macroglobulinemia||Biological: Ipilimumab Radiation: Radiation therapy||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A PHASE I/II STUDY OF INTRATUMORAL INJECTION OF IPILIMUMAB IN COMBINATION WITH LOCAL RADIATION IN MELANOMA, NON-HODGKIN LYMPHOMA AND COLORECTAL CARCINOMA|
- Dose-limiting Toxicity [ Time Frame: 4 weeks ]Safety as the percentage of patients experiencing dose-limiting toxicities (DLTs) or serious adverse events (SAEs) using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I)
- Immune Response (Phase 2 Only) [ Time Frame: 4 weeks ]Data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.
- Immune Response (Phase 2 Only) [ Time Frame: 8 weeks ]Data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.
- Response Rate (Phase 2 Only) [ Time Frame: 8 weeks ]Response rates calculated based on the Response Evaluation Criteria in Solid Tumors (RECIST)/RECIST Immunotherapy and Cheson criteria (Phase 2 only). Response rate data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.
- Overall Survival (Phase 2 Only) [ Time Frame: Up to 5 years ]Data will be summarized using Kaplan-Meier estimates for time to event data.
- Duration of Response (Phase 2 Only) [ Time Frame: Up to 5 years ]Data will be summarized using Kaplan-Meier estimates for time to event data.
|Study Start Date:||February 2013|
|Study Completion Date:||June 2015|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Experimental: Ipilimumab 25 mg
Participants receive ipilimumab intratumorally on Day 1
Experimental: Ipilimumab 25 mg and radiation therapy
Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions
Other Names:Radiation: Radiation therapy
Undergo local radiation therapy, 10 Gy x 3 fractions
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.
- To assess the induction of an anti-tumor immune responses using laboratory correlative studies.
- To determine tumor response rates and duration of response at unirradiated tumor sites in patients with advanced malignancies.
- To identify putative immunologic biomarkers of tumor response.
OUTLINE: This is a phase I dose-escalation study of ipilimumab, followed by a phase 2 study. Only a few subjects participated in the phase 1 portion of this study. The phase 2 portion of this study 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769222
|United States, California|
|Stanford, California, United States, 94305|
|Principal Investigator:||George A. Fisher, MD, PhD||Stanford University|