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Panobinostat (LBH589) Plus Everolimus (RAD001) in Patients With Relapsed and Refractory Lymphoma

2014-07-23 21:13:31 | BioPortfolio

Summary

The goal of Phase 1 of this clinical research study is to learn the highest tolerable dose of the combination of LBH589 (panobinostat) and RAD001 (everolimus) that can be given to patients with relapsed or refractory lymphoma. The safety of this drug combination will also be studied.

The goal of Phase II of this clinical research study is to learn if the combination of LBH589 (panobinostat) and RAD001 (everolimus) can help to control relapsed or refractory lymphoma. The safety of this drug combination will also be studied.

Description

Phase 1:

The Study Drugs:

Both panobinostat and everolimus are designed to block cancer cells from multiplying. Everolimus may also stop the growth of new blood vessels that help tumor growth. As a result, the cancer cells may grow more slowly or die.

Study Groups:

If you are found to be eligible to take part in this phase of the study, you will be assigned to a study group based on when you joined this study. Up to 5 groups of 3-6 participants will be enrolled in this phase of the study.

If you are enrolled in this phase of the study, the dose of study drugs you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of the study drugs. Each new group may receive a higher dose of study drugs than the group before it, if no intolerable side effects were seen. This will continue for up to 5 combinations of the study drugs, until the highest tolerable dose of study drugs in combination is found.

Up to 2 dose levels of everolimus and up to 4 dose levels of panobinostat will be tested in this phase of the study. This is up to 5 different dose combinations of everolimus and panobinostat. (The dose of both drugs does not get raised in every dose level, but sometimes only 1 drug's dose gets raised.)

Study Drug Administration:

Panobinostat:

You will take panobinostat by mouth 3 times a week during each cycle. Cycles in this study are 28 days long.

You should take panobinostat with 1 cup (8 ounces) of water at about the same time each day that you take it.

If you miss a dose of panobinostat, take it as soon as you remember it on the same day. However, if more than 12 hours have passed since you were supposed to take the dose, you should skip that day's dose. In that case, wait to take panobinostat until the next scheduled treatment day.

Everolimus:

You will take everolimus every day, at about the same time in the morning. You will take it by mouth with 1 cup (8 ounces) of water, after you eat a low-fat meal.

Examples of low-fat meals include cereal with fat-free milk, a muffin, toast, a bagel with fat-free spread, or fruit salad.

The reason to avoid high-fat breakfasts while you are taking everolimus is to help the drug get absorbed better by your body.

If you experience intolerable side effects, you must call your doctor right away. The doctor may then lower the dose of study drug or take you off study.

Study Visits:

Within 7 days before the first dose of study drug:

- You will be asked about any drugs you may be taking.

- Blood (about 2 1/2 teaspoons) and urine will be collected for routine tests.

- Women who are able to become pregnant will have a blood (about 1 tablespoon) pregnancy test.

On Day 1 of Cycle 1:

- You will have a physical exam, including measurement of your weight and vital signs.

- You will be asked about any drugs you may be taking and any side effects that may have occurred.

- Your performance status will be recorded.

- Blood (about 2 1/2 teaspoons) will be drawn for routine tests.

- Blood (about 1 teaspoon) will be drawn for biomarker research.

- If your doctor thinks it is needed, urine will be collected for routine tests.

- Women who are able to become pregnant will have a blood (about 1 tablespoon) pregnancy test.

On Days 1 and 5 of Cycle 1, you will have an ECG.

On Weeks 2, 3, and 4 of Cycle 1, blood (about 2 1/2 teaspoons) will be drawn for routine tests.

On Week 2 of Cycle 1, blood (about 1 teaspoon) will be drawn for biomarker research.

On Day 1 of Cycle 2 and every cycle after that:

- You will have a physical exam, including measurement of your weight and vital signs.

- You will be asked about any drugs you may be taking and any side effects that may have occurred.

- Your performance status will be recorded.

- You will have an ECG (or more than 1 ECG if the doctor thinks it is needed).

- Blood (about 2 1/2 teaspoons) will be drawn for routine tests.

- Women who are able to become pregnant will have a blood (about 1 tablespoon) pregnancy test.

Every 8 weeks:

- You will have a PET scan to check the status of the disease.

- You will have a CT scan of your head and neck, chest, abdomen, and pelvis to check the status of the disease.

Length of Study:

If you show benefit from taking the study drugs, you may receive up to 6 cycles. You will be taken off study if you have intolerable side effects or the disease gets worse.

End-of-Treatment Visit:

After you stop taking the study drugs, you will return to the clinic for an end-of-treatment visit:

- You will have a physical exam, including measurement of your weight and vital signs.

- Your performance status will be recorded.

- You will have an ECG.

- You will be asked about any drugs you may be taking.

- Blood (about 3 1/2 teaspoons) will be collected for routine tests.

- You will have a PET scan to check the status of the disease.

- You will have a computed tomography (CT) scan of your head and neck, chest, abdomen, and pelvis to check the status of the disease.

- If your doctor thinks it is needed, urine will be collected for routine tests.

- If the doctor thinks the disease has responded completely, you will have a bone marrow biopsy and aspiration to confirm the complete response. To collect a bone marrow biopsy/aspirate, an area of the hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.

Women who are able to become pregnant will have a blood (about 1 tablespoon) pregnancy test.

Up to 18 patients will take part in this phase of this study. All will be enrolled at M. D. Anderson.

Phase 2:

Study Drug Administration:

Panobinostat:

You will take panobinostat by mouth 3 times a week during each cycle. Cycles in this study are 28 days long.

You should take panobinostat with 1 cup (8 ounces) of water at about the same time each day that you take it.

If you miss a dose of panobinostat, take it as soon as you remember it on the same day. However, if more than 12 hours have passed since you were supposed to take the dose, you should skip that day's dose. In that case, wait to take panobinostat until the next scheduled treatment day.

Everolimus:

You will take everolimus every day, at about the same time in the morning. You will take it by mouth with 1 cup (8 ounces) of water, after you eat a low-fat meal.

Examples of low-fat meals include cereal with fat-free milk, a muffin, toast, a bagel with fat-free spread, or fruit salad.

The reason to avoid high-fat breakfasts while you are taking everolimus is to help the drug get absorbed better by your body.

If you experience intolerable side effects, you must call your doctor right away. The doctor may then lower the dose of study drug or take you off study.

Study Visits:

Within 7 days before the first dose of study drug:

- You will be asked about any drugs you may be taking.

- Blood (about 2 1/2 teaspoons) and urine will be collected for routine tests.

- Women who are able to become pregnant will have a blood (about 1 tablespoon) pregnancy test.

On Day 1 of Cycle 1:

- You will have a physical exam, including measurement of your weight and vital signs.

- You will be asked about any drugs you may be taking and any side effects that may have occurred.

- Your performance status will be recorded.

- Blood (about 2 1/2 teaspoons) will be drawn for routine tests.

- Blood (about 1 teaspoon) will be drawn for biomarker research.

- If your doctor thinks it is needed, urine will be collected for routine tests.

- Women who are able to become pregnant will have a blood (about 1 tablespoon) pregnancy test.

On Days 1 and 5 of Cycle 1, you will have an ECG.

On Weeks 2, 3, and 4 of Cycle 1, blood (about 2 1/2 teaspoons) will be drawn for routine tests.

On Week 2 of Cycle 1, blood (about 1 teaspoon) will be drawn for biomarker research.

On Day 1 of Cycle 2 and every cycle after that:

- You will have a physical exam, including measurement of your weight and vital signs.

- You will be asked about any drugs you may be taking and any side effects that may have occurred.

- Your performance status will be recorded.

- You will have an ECG (or more than 1 ECG if the doctor thinks it is needed).

- Blood (about 2 1/2 teaspoons) will be drawn for routine tests.

- Women who are able to become pregnant will have a blood (about 1 tablespoon) pregnancy test.

Every 8 weeks:

- You will have a PET scan to check the status of the disease.

- You will have a CT scan of your head and neck, chest, abdomen, and pelvis to check the status of the disease.

Length of Study:

You may continue receiving the study drugs for as long as you are benefitting. You will be taken off study if you have intolerable side effects or the disease gets worse.

End-of-Treatment Visit:

After you stop taking the study drugs, you will return to the clinic for an end-of-treatment visit:

- You will have a physical exam, including measurement of your weight and vital signs.

- Your performance status will be recorded.

- You will have an ECG.

- You will be asked about any drugs you may be taking.

- Blood (about 3 1/2 teaspoons) will be collected for routine tests.

- You will have a PET scan to check the status of the disease.

- You will have a computed tomography (CT) scan of your head and neck, chest, abdomen, and pelvis to check the status of the disease.

- If your doctor thinks it is needed, urine will be collected for routine tests.

- If the doctor thinks the disease has responded completely, you will have a bone marrow biopsy and aspiration to confirm the complete response. To collect a bone marrow biopsy/aspirate, an area of the hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.

- Women who are able to become pregnant will have a blood (about 1 tablespoon) pregnancy test.

This is an investigational study. Panobinostat is not FDA approved or commercially available. At this time the drug is being used in research only. Everolimus is FDA approved and commercially available for the treatment of renal cell carcinoma. Using everolimus in combination with panobinostat in patients with lymphoma is investigational.

Up to 42 patients will take part in this phase of this study. All will be enrolled at M. D. Anderson.

Study Design

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

Conditions

Lymphoma

Intervention

Panobinostat, Everolimus

Location

UT 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: 2014-07-23T21:13:31-0400

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Medical and Biotech [MESH] Definitions

A leukemia/lymphoma found predominately in children and young adults and characterized LYMPHADENOPATHY and THYMUS GLAND involvement. It most frequently presents as a lymphoma, but a leukemic progression in the bone marrow is common.

B-cell lymphoid tumors that occur in association with AIDS. Patients often present with an advanced stage of disease and highly malignant subtypes including BURKITT LYMPHOMA; IMMUNOBLASTIC LARGE-CELL LYMPHOMA; PRIMARY EFFUSION LYMPHOMA; and DIFFUSE, LARGE B-CELL, LYMPHOMA. The tumors are often disseminated in unusual extranodal sites and chromosomal abnormalities are frequently present. It is likely that polyclonal B-cell lymphoproliferation in AIDS is a complex result of EBV infection, HIV antigenic stimulation, and T-cell-dependent HIV activation.

A form of undifferentiated malignant LYMPHOMA usually found in central Africa, but also reported in other parts of the world. It is commonly manifested as a large osteolytic lesion in the jaw or as an abdominal mass. B-cell antigens are expressed on the immature cells that make up the tumor in virtually all cases of Burkitt lymphoma. The Epstein-Barr virus (HERPESVIRUS 4, HUMAN) has been isolated from Burkitt lymphoma cases in Africa and it is implicated as the causative agent in these cases; however, most non-African cases are EBV-negative.

Two or more distinct types of malignant lymphoid tumors occurring within a single organ or tissue at the same time. It may contain different types of non-Hodgkin lymphoma cells or both Hodgkin and non-Hodgkin lymphoma cells.

A systemic, large-cell, non-Hodgkin, malignant lymphoma characterized by cells with pleomorphic appearance and expressing the CD30 ANTIGEN. These so-called "hallmark" cells have lobulated and indented nuclei. This lymphoma is often mistaken for metastatic carcinoma and MALIGNANT HISTIOCYTOSIS.

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