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Study of Weekly LOC-paclitaxel Injection for Melanoma

2014-07-24 14:10:29 | BioPortfolio

Summary

The goal of this clinical research study is to find the highest tolerable dose of LOC-paclitaxel when given to patients with metastatic melanoma. The safety of this drug and if it can control the disease is also being studied.

Description

The Study Drug:

Paclitaxel is designed to block cancer cells from dividing, which may cause them to die. LOC-paclitaxel is a redesigned version of paclitaxel. Fatty acid is added to paclitaxel, which may help paclitaxel to stay in the tumor for longer at higher concentrations. This is the first study using LOC-paclitaxel in humans.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of LOC-paclitaxel based on when you joined this study. Up to 7 dose levels of LOC-paclitaxel will be tested. Three (3) to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of LOC-paclitaxel is found.

Once the highest tolerable dose of LOC-paclitaxel is found, 12 participants will receive the study drug at that dose level.

Study Drug Administration:

Each study cycle is 6 weeks.

You will receive LOC-paclitaxel by vein over 1 hour on Days 1, 8, 15, 22, and 29 of each cycle.

If you experience side effects, your dose of study drug may be lowered.

Study Visits:

On Day 1 of each cycle:

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

- Your performance status will be recorded.

- Blood (about 1 tablespoon) will be drawn for routine tests and to test for tumor markers.

- If you have melanoma of the head and neck, you will have a CT scan of the neck.

- If you have skin lesions, photographs will be taken of the lesions. Your private areas will be covered (as much as possible), and a picture of your face will not be taken unless there are lesions on your face. You will not be able to be identified by any pictures that may be taken of your lesions.

Once a week:

- Blood (about 1 teaspoon) will be drawn to check your blood cell counts.

- Urine will be collected for routine tests.

- You will be asked if you experienced any side effects.

Every 6 weeks, you will have x-rays and CT scans to check the status of the disease as per standard of care. If you have had a response to treatment (the disease has disappeared or the tumors have gotten smaller), the x-rays and CT scans will be repeated again in 4 weeks. After that, they will be repeated every 6 weeks.

If you experience low blood counts while you are on study, and the doctor thinks it is severe, you will have a bone marrow biopsy to check for the cause of the low blood counts.To collect a bone marrow biopsy, an area of the hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.

If the doctor thinks it is needed, you will have ECGs and extra blood (about 1 teaspoon) will be drawn.

Any of the procedures listed in this consent form may be performed more frequently, if your doctor thinks they are needed.

Pharmacokinetic (PK) Testing:

Extra blood will also be drawn for PK testing. PK testing measures the amount of study drug in the body at different time points. Blood (about 2 teaspoons each time) will be drawn at the following times:

- On Day 1 of Cycle 1, blood will be drawn before the dose of LOC-paclitaxel, at the end of the dose, and then 5 more times over the next 11 hours after the dose.

- On Days 2-7 of Cycle 1, blood will be drawn 1 time each day.

- On Days 8, 15, and 22 of Cycle 1, blood will be drawn 1 time each day.

- On Day 29 of Cycle 1, blood will be drawn before the dose, at the end of the dose, and then 5 more times over the next 11 hours after the dose.

- On Days 30-35 of Cycle 1, blood will be drawn 1 time each day.

Length of Study:

You will be on study for as long as you are benefiting. You will be taken off the study if you experience intolerable side effects or the disease gets worse.

End-of-Study Visit:

After you are off study, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed:

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

- Your performance status will be recorded.

- Blood (about 1 tablespoon) will be drawn for routine tests and to measure tumor markers.

- You will have CT scans to check the status of the disease.

- If you are having low blood counts, you will have a bone marrow biopsy to check for side effects.

- If you have skin lesions, photographs will be taken of the lesions.

After you go off study, extra tests may be needed for your safety. This may include routine blood tests (about 1 tablespoon) and will be continued until you have recovered from any side effects, which may be 3-4 weeks.

Additional Information:

During this study, you will not be allowed to receive any other anticancer treatments (such as chemotherapy or other investigational therapy).

This is an investigational study. LOC-paclitaxel is not FDA approved or commercially available. LOC-paclitaxel is currently being used for research purposes only.

Up to 60 patients will take part in 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

Melanoma

Intervention

LOC-paclitaxel

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: 2014-07-24T14:10:29-0400

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