Clinical trial NCT01485536
Conditions: Lymphoma
Keywords: Lymphoma Relapsed/refractory lymphoma AUY922
Sponsor: M.D. Anderson Cancer Center
Start date: 2012-08-01; Completion date: 2015-11-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if AUY922 can help to control refractory or recurrent lymphoma. The safety of AUY922 will also be studied.

AUY922 is designed to block tumor growth by blocking a protein.

Detailed description:
Study Drug Administration:

If you are found to be eligible to take part in this study, you will receive AUY922 by vein over about 1 hour on Days 1, 8, 15, and 22 of each 28-day cycle.

Study Visits:

On Days 1 and 15 of Cycles 1-12:

* You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
* Your performance status will be recorded.
* You will be asked about any drugs you may be taking and any side effects you may have had.
* Blood (about 6-7 teaspoons) will be drawn for routine tests. On Day 1 of Cycle 1, this blood will also be used to check your heart function.
* You will have ECGs before and after the study drug infusion.

On Day 8 of Cycles 1-12:

* Your vital signs will be measured.
* You will be asked about any drugs you may be taking and any side effects you may have had.
* Blood (about 6-7 teaspoons) will be drawn for routine tests and to check your heart function.
* You will have ECGs before and after the study drug infusion.

On Day 1 of Cycles 1 and 2:

* Urine will be collected for routine tests.
* Blood (about 1 teaspoon) will be drawn to check your blood clotting function.

On Days 2 and 3 of Cycle 1:

* Blood (about 5-6 teaspoons) will be drawn for routine tests.
* You will have ECGs at about 24 and 48 hours after the end of the infusion.
* You will be asked about any drugs you may be taking, any side effects you may be having, and about your overall health.

On Day 22 of Cycle 1:

* You will have a physical exam, including measurement of your vital signs.
* Your performance status will be recorded.
* You will be asked about any drugs you may be taking, any side effects you may be having, and about your overall health.
* Blood (about 5-6 teaspoons) will be drawn for routine tests.

After every 2 cycles:

* You will have CT and PET scans to check the status of the disease.
* You will be asked about any side effects you may be having and about your overall health.

Anytime the study doctor thinks it is needed, you will have an eye exam or other tests.

Length of Study:

You may continue taking AUY922 for up to 12 cycles. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

End-of-Treatment Visit:

At 28 days after your last dose:

* Blood (about 5-6 teaspoons) and urine will be collected for routine tests.
* Blood (about 1 teaspoon) will be drawn to check your blood clotting function.
* You will have a physical exam, including measurement of your vital signs.
* Your performance status will be recorded.
* You will have an eye exam by an eye doctor.
* You will have CT and PET scans to check the status of the disease.
* You will be asked about any drugs you may be taking, any side effects you may be having, and about your overall health.

Long-Term Follow-Up:

After you stop the study drug, you will have a CT scan and physical exam every 3 months for 1 year, then every 4 months for another year, and every 6 months for 3 years and then 1 time a year after that.

This is an investigational study. AUY922 is not FDA approved or commercially available. It is currently being used for research purposes only.

Up to 42 patients will take part in this study. All will be enrolled at MD Anderson.

Arms: arm 1: AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
Interventions: intervention 1: AUY922
Intervention descriptions: intervention 1: Starting Dose: 70 mg/m2 by vein on days 1, 8, 15, and 22 days of a 28 day cycle.

Protocol documents: