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MPDL3280A With Chemoradiation for Lung Cancer

2015-08-17 19:53:21 | BioPortfolio

Summary

The goal of this clinical research study is to learn about the safety of adding MDPL3280A to standard chemotherapy (a combination of carboplatin and paclitaxel) and radiation in patients with lung cancer.

Description

Study Groups and Study Drug Administration:

Each study cycle is 21 days.

If you are found to be eligible to take part in this study, depending on when you join the study, you will be assigned to 1 of 2 study groups. Up to 10 participants will be assigned to Group 1 and up to 30 will be assigned to Group 2.

Participants in Groups 1 and 2 will receive standard chemotherapy 1 time each week and radiation therapy 5 days per week as described below Every cycle you will also receive MPDL3280A by vein over about 1 hour.

If you are in Group 1, you will receive standard chemotherapy and radiation for 6-7 weeks, followed by a 3-4 week "rest period" when you will receive no chemotherapy or radiation.

If you are in Group 2, you will receive MPDL3280A, standard chemotherapy, and radiation therapy for 6-7 weeks. This will be followed by a rest period of 3-4 weeks, during which time you will receive 1 dose of MPDL3280A but no chemotherapy or radiation.

After the rest period, Groups 1 and 2 will both receive MPDL3280A in addition to chemotherapy for 2 cycles (called the consolidation period). After completing the consolidation period, you will continue to receive MPDL3280A alone for up to 1 year (called the maintenance period).

During your first dose of MPDL3280A, your vital signs (blood pressure, pulse, temperature, and breathing rate) will be measured 60 minutes before the dose, every 15 minutes during the dose, and 30 minutes after the dose to check for any bad reaction to the study drug. You may be given standard drugs to help with side effects.

If you need to stop receiving chemotherapy due to side effects, you will also stop receiving MPDL3280A. If you stop receiving chemotherapy for any other reason, you may continue receiving MPDL3280A.

Study Visits:

Once a week during Weeks 1-7:

- You will have a physical exam.

- Blood (up to 2 teaspoons) will be drawn for routine tests and to check your liver and kidney function.

Once during Weeks 8-12 (the rest period), blood (about 2 teaspoons) will be drawn for routine tests.

One (1) time during Weeks 12-15 and Weeks 15-18 (the consolidation period):

- You will have a physical exam.

- Blood (up to 2 teaspoons) will be drawn for routine tests and to check your liver and kidney function.

- During Weeks 12-15 only, you will have either a CT scan or an FDG-PET/CT scan to check the status of the disease.

After you complete the consolidation period, you will enter the maintenance period. During every cycle of the maintenance period, blood (about 2 teaspoons) will be drawn for routine tests.

Every 2 cycles during the maintenance period, for up to 1 year:

- You will have a physical exam.

- You will have either a CT scan or an FDG-PET/CT scan to check the status of the disease.

If the disease appears to come back at any time during the study:

- You will have a physical exam.

- You will have a CT scan or MRI of the brain to check the status of the disease.

- You will have either a CT scan or an FDG-PET/CT of your chest and abdomen to check the status of the disease.

- You will have a biopsy of any suspicious areas found on the scans to check the status of the disease.

- Your doctor may choose to continue the study drug and repeat the scans in 6-8 weeks to check the status of the disease.

- If your doctor feels that the study drug is no longer effective from the information obtained from the repeat scans, you will be taken off the study drug. You will continue to be followed up by a schedule determined by your doctor.

- Your doctor may offer alternative treatments if your doctor feels it is in your best interest.

Length of Treatment:

You may receive the study drug for up to 1 year after starting the consolidation period, as long as the doctor thinks it is in your best interest. You will no longer be able to receive study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

If you are taken off study during the consolidation or maintenance period due to intolerable side effects, you will be followed by the study staff as often the doctor thinks is needed until the side effects get better.

Your active participation on the study will be over after the follow-up visits.

Follow-up Visits:

You will have follow-up visits every 2-4 months for up to 2 years after your last dose of study drug, unless you leave the study due to side effects or the disease having appeared to come back. After 2 years, you will have follow-up visits about every 4-6 months based on what your doctor thinks is best.

At each follow-up visit, the following tests will be performed:

- You will have a physical exam.

- You will have either a CT scan or an FDG-PET/CT scan of your chest and abdomen to check the status of the disease.

- If your doctor thinks it is needed, blood (up to 2 teaspoons) will be drawn for routine tests and to check your liver and kidney function.

If you cannot return to MD Anderson for these visits, you may be called by a member of the study staff every 3-6 months for 4 years after the last dose of study drug. Each call should last about 10 minutes. The study staff may ask that any tests or scans done by your home doctor be sent to MD Anderson to check the status of the disease.

This is an investigational study. MPDL3280A is not FDA approved or commercially available. It is currently being used for research purposes only. Paclitaxel, carboplatin, and the radiation therapy are all FDA approved for the treatment of lung cancer. The use of these drugs in combination is considered investigational.

Up to 40 participants will be enrolled in this study. All will take part at MD Anderson.

Study Design

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

Conditions

Lung Cancer

Intervention

MPDL3280A, Carboplatin, Paclitaxel, Radiation Therapy

Location

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

Status

Not yet recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-08-17T19:53:21-0400

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