Ipilimumab and Stereotactic Body Radiation Therapy (SBRT) in Advanced Solid Tumors

Lung Cancer Clinical Trial

Official title: Phase I/II Trial of Ipilimumab (Immunotherapy) and Hypofractionated Stereotactic Radiation Therapy in Patients With Advanced Solid Malignancies

Status Completed

Clinical Trial Summary

The goal of this clinical research study is to find the highest tolerable dose of ipilimumab and stereotactic body radiation therapy (SBRT). The safety and effectiveness of these treatments given consecutively will also be studied.

This is an investigational study. SBRT is FDA approved for the control of metastatic and primary tumors. Ipilimumab is FDA approved and commercially available for the treatment of metastatic melanoma that cannot be removed with surgery. The use of SBRT with ipilimumab is investigational. The study doctor can explain how the study drug is designed to work.

Up to 120 participants will be enrolled in this study. All will take part at MD Anderson.

Clinical Trial Description

Study Groups:

Participants on this study are enrolled into Phase 1 (Dose De-Escalation, or Dose-Finding) or Phase 2 (Dose Expansion), based on when they join the study.

Phase 1: Dose De-Escalation:

If you are found to be eligible to take part in this study, you will be assigned to 1 of 5 groups based on the type of disease you have.

• If you are in Groups 1 or 3, you will receive SBRT and 1 dose of ipilimumab within a few days after your SBRT treatment, and then you will receive 3 more doses of ipilimumab.

• If you are in Groups 2, 4, or 5, you will receive 2 doses of ipilimumab, SBRT, and then 2 more doses of ipilimumab.

If you are in Group 5, SBRT will be given over a longer period of time (more days or weeks).

All participants will receive the same dose level of ipilimumab.

You will be given a separate consent form explaining SBRT and its risks.

In each group, 3 participants will be enrolled at the first dose level. If no more than 1 participant has intolerable side effects, up to 3 more participants will be enrolled at that dose level. If no intolerable side effects are seen at that dose level, that is considered the highest tolerated dose.

If enough intolerable side effects are seen at the assigned dose level, the total dose amount of radiation given in any group may be lowered up to 2 times.

Phase 2: Dose Expansion:

Once the highest tolerated dose combination is found in each study group, up to 14 more participants will be enrolled at that dose level combination in each group.

Study Drug Administration:

Each study cycle is 21 days.

If you are in Groups 1 or 3 (early ipilimumab and SBRT), you will receive ipilimumab by vein over about 90 minutes on Day 1 of all cycles. You will also receive SBRT over about 30-45 minutes on Days 1-4 of Cycle 1.

If you are in Groups 2 or 4 (late ipilimumab and SBRT), you will receive ipilimumab by vein over about 90 minutes on Day 1 of Cycles 1 and 2 and then SBRT on Days 29-33. After your SBRT treatment, you will take ipilimumab on Day 1 of Cycles 3 and 4.

If you are in Group 5 (late ipilimumab and SBRT), you will receive ipilimumab on Day 1 of Cycle 1 and SBRT over about 30-45 minutes on Days 1-5 and Days 9-12 of Cycle 1. After your SBRT treatment, you will take ipilimumab on Day 1 of Cycles 2-4.

You will be given standard drugs to help decrease the risk of side effects and to help support your immune system. You may ask the study staff for information about how the drugs are given and their risks.

Study Visits:

During Week 1 of all cycles and Week 2 of Cycle 2:

• You will have a physical exam, including measurement of your weight.

• Blood (about 1 tablespoon) will be drawn for routine tests.

During Week 3 of Cycles 2 and 4, you will have an MRI, CT scan, and/or PET/CT scan to check the status of the disease.

If you are in Phase 2, during Week 3 of each cycle, blood (about 2 teaspoons) may be drawn for biomarker testing, if the doctor thinks it is safe.

You may have a chest scan if the doctor thinks it is needed.

Length of Study:

You may receive up to 4 cycles of treatment with ipilimumab and SBRT. About 8 weeks after you have completed Cycle 4, if the size of the tumor does not change or it gets smaller while you are receiving therapy, you may be able to continue to receive ipilimumab and/or radiation. The study doctor will discuss this option with you.

You will no longer be able to receive treatment if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

Your participation on the study will be over after you have completed the follow-up visits.

Follow-Up:

About 30 days after your last dose of ipilimumab and then every 3 months after that for up to 2 years, you will come to the clinic for follow-up visits. At these visits:

• You will have a physical exam, including measurement of your weight..

• Blood (about 1 tablespoon) be drawn for routine tests.

• Blood (about 2 teaspoons) may be drawn for biomarker testing, if the doctor thinks it is safe.

• Urine will be collected for routine tests.

• You will have an MRI, CT scan, and/or PET/CT scan to check the status of the disease. ;

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms
• Lung Cancer

• NCT number: NCT02239900
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 1
• Start date: August 26, 2014
• Completion date: October 25, 2019