Ipilimumab and Local Radiation for Selected Solid Tumors

Summary

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.

Conditions

• 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

Interventions

BIOLOGICAL

Ipilimumab

Given intratumorally

RADIATION

Radiation therapy

Undergo local radiation therapy, 10 Gy x 3 fractions

Sponsors & Collaborators

• Stanford University

  lead OTHER

Principal Investigators

• George A. Fisher, MD, PhD · Stanford University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-02-28

Primary Completion

2014-11-30

Completion

2015-06-30

FDA Drug

Yes

Countries

• United States

Study Locations