Clinical Trial: Ipilimumab and Local Radiation Therapy in Treating Patients With Recurrent Melanoma, Non-Hodgkin Lymphoma, Colon, or Rectal Cancer

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief Summary: This pilot phase I/II 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

Detailed Summary:

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 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.


Sponsor: Stanford University

Current Primary Outcome: 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)


Original Primary Outcome: Safety as the percentage of patients experiencing dose limiting toxicities (DLTs) or serious adverse events using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I) [ Time Frame: 4 weeks ]

Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

  • Immune response (Phase II) [ Time Frame: 4 weeks ]
    Data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.
  • Immune response (Phase II) [ Time Frame: 8 weeks ]
    Data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.
  • Response rate (complete response [CR], partial response [PR], stable disease [SD]) calculated based on the Response Evaluation Criteria in Solid Tumors (RECIST)/RECIST Immunotherapy and Cheson criteria (Phase II) [ Time Frame: 8 weeks ]
    Data will be summarized using proportions with exact 95% confidence intervals, means, standard deviations, and ranges.
  • Overall survival (Phase II) [ Time Frame: Up to 5 years ]
    Data will be summarized using Kaplan-Meier estimates for time to event data.
  • Duration of response (Phase II) [ Time Frame: Up to 5 years ]
    Data will be summarized using Kaplan-Meier estimates for time to event data.


Information By: Stanford University

Dates:
Date Received: January 14, 2013
Date Started: February 2013
Date Completion:
Last Updated: January 12, 2017
Last Verified: January 2017