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A Phase I/II Study of TPI 287 - Temozolomide Combination in Melanoma

2014-08-27 03:16:00 | BioPortfolio

Summary

Phase I portion of study To determine the Maximum Tolerated Dose (MTD), as measured by clinical and laboratory adverse events, for the administration of TPI 287 administered weekly for three weeks out of every four, and then combined with temozolomide (Temodar) in patients with metastatic melanoma.

Phase II portion of study

1. Primary objective: To estimate the efficacy of TPI 287 - temozolomide combination as measured by percent of patients without tumor progression at 6 months,

2. Secondary objectives:

1. To evaluate the response rate, response duration, median progression-free survival (PFS), overall survival of patients with metastatic melanoma treated with TPI 287 - temozolomide combination.

2. To determine the long-term toxicity of TPI 287, administered intravenously on days 1, 8 and 15 (+/- 1 day) every four weeks plus temozolomide, given orally, once a day for five days every cycle (Days 1 through 5 [+1 day]) for the treatment of patients with metastatic melanoma.

Description

Study Drugs:

TPI 287 is designed to block tumors from growing by preventing cancer cells from dividing.

Temozolomide is designed to kill cancer cells by causing breaks in the DNA (genetic material) of the cell.

Screening Tests:

You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed on within 2 weeks before the first dose of study drugs (if eligible).

- Your complete medical history will be recorded.

- You will have a complete physical exam, including measurements of height, weight, and vital signs (temperature, heart rate, breathing rate, and blood pressure).

- You will be asked how well you are able to perform the normal activities of daily living (performance status).

- Blood (about 2 teaspoons) will be collected for routine blood tests. You may also be tested for HIV.

- You will have a chest X-ray to check the status of the disease.

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

- You will have an magnetic resonance imaging (MRI) scan of the brain to check on the status of the disease.

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

- Women who are able to have children must have a negative blood (about 1 teaspoon) or urine pregnancy test.

The study doctor will discuss the screening test results with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other treatment options will be discussed with you.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you joined this study. Up to 8 groups of 6 participants will be enrolled in the Phase I portion of the study, and up to 64 participants will be enrolled in Phase II.

If you are enrolled in the Phase I portion, the dose of TPI 287 and temozolomide you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of TPI 287 and temozolomide. Each new group will receive a higher dose of TPI 287 and temozolomide than the group before it, if no intolerable side effects were seen. If any of these participants have a dose limiting toxicity, 6 additional participants will be added at the same dose. If a dose limiting toxicity occurs again, the dose level below this will be considered the maximum tolerated dose.

If any participant experiences a life threatening side effect, no additional participants will be enrolled into that dose level and no higher doses will be given. An additional 3 participants will be treated at the dose level below the one with life threatening toxicity. Once the maximum tolerated dose of the combination is found, Phase II of the study will open.

If you are enrolled in the Phase II portion, you will receive the drug combination at the highest dose that was tolerated in the Phase I portion

Central Venous Catheter (CVC):

You will have a CVC placed. A CVC is a sterile, flexible tube that will be placed into a large vein while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form for this procedure.

Study Drug Administration:

You will receive TPI 287 by vein over 1 hour on Days 1, 8, and 15 (+/- 1 day) of each 28 day study cycle. Before you receive each dose of TPI 287, you will receive dexamethasone, Benadryl (diphenhydramine), and Pepcid (famotidine) by vein to help prevent allergic reaction. You will also receive drugs to prevent nausea and vomiting. Your vital signs will be measured before and 30 minutes following the end of the infusion of TPI 287. Your vitals will be measured more often, if needed.

You will take temozolomide tablets by mouth on Days 1-5 at bedtime. You should not eat for at least 1 hour before and 1 hour after taking temozolomide.

Study Visits:

Before each cycle, your performance status will be recorded and you will have a physical exam.

On Days 1, 8, and 14 of each cycle:

- Blood (about 1 teaspoon) will be drawn for routine tests before you receive TPI 287.

- You will also be asked about any symptoms you may be experiencing and any drugs you are taking.

On Day 22 of each cycle:

- Blood (about 1 teaspoon) will be drawn for routine tests.

- You will also be asked about any symptoms you may be experiencing and any drugs you are taking.

Every 8 weeks, you will have a CT scan or MRI scan to check the status of the disease. If you have brain metastasis, you will have the scans every 4 weeks.

Length of Study:

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

End-of-Treatment Visit:

About 4 weeks after you stop taking TPI 287 in combination with Temozolomide, you have an end-of-study visit. At this visit, the following tests and procedures will be performed:

- You will have a physical exam.

- You will be asked about any complications or side effects you may be experiencing.

- Blood (about 2 tablespoons) will be drawn for routine tests.

- If your doctor thinks it is needed, you will have a CT scan or MRI scan to check the status of the disease.

Additional Information:

- You must follow all instructions and directions you are given while on study.

- You must check with your doctor first if you need to take any new over-the-counter drugs or herbal supplements, or if you need to change your usual prescription drugs during this study.

- You should not have any immunizations (vaccinations) without telling your doctor first.

- You should not donate blood while on study or for 70 days after your last dose of the study drug.

- You must tell your doctor about any medical treatments that you will have to get during the study (such as elective surgery).

Certain drugs cannot be taken while you are in this study. Your doctor will explain what these medications are. If you need treatment with any medications that are not allowed during this study, you must tell your doctor or the study staff. You will not be denied medications required to treat an illness you may have, but you may be required to stop taking the study drugs.

This is an investigational study. TPI 287 is not FDA approved or commercially available. At this time, TPI 287 is being used in research only. Temozolomide is FDA approved and commercially available for primary brain cancer. The use of temozolomide in combination with TPI 287 is investigational.

Up to 106 patients will take part in this study. All patients 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

Melanoma

Intervention

TPI 287, Temodar (Temozolomide)

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: 2014-08-27T03:16:00-0400

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