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

2014-09-16 13:08:21 | BioPortfolio

Summary

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

Description

Study Groups:

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 intolerable side effects are seen, the total dose amount of radiation given in any group may be lowered up to 3 times.

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

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

All participants will receive the same dose level of ipilimumab.

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.

- Urine will be collected for routine tests.

- You will have an electrocardiogram (EKG) to check your heart function.

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.

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. 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.

- Urine will be collected for routine tests.

- You will have an electrocardiogram (EKG) to check your heart function.

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

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 100 participants will be enrolled in this study. All will take part at MD Anderson.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Liver Cancer

Intervention

Ipilimumab, Stereotactic Body Radiation Therapy (SBRT)

Location

University of Texas MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-09-16T13:08:21-0400

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