Temozolomide, Thalidomide, and Lomustine (TTL) in Melanoma Patients

Melanoma Clinical Trial

Official title: A Phase I Study of Temozolomide, Thalidomide, and Lomustine (TTL) in Patients With Metastatic Melanoma in the Brain

Status Completed

Clinical Trial Summary

The goal of this clinical research study is to find the highest safe dose of lomustine (CCNU, CeeNUTM) that can be given with temozolomide (TemodarTM) and thalidomide (ThalomidTM) in the treatment of metastatic melanoma that has spread to the brain. The safety and effectiveness of this combination therapy will also be studied.

Clinical Trial Description

Temozolomide works by blocking a tumor cell's ability to grow. Lomustine is also a chemotherapy drug that works by killing tumor cells. Studies have shown that when lomustine and temozolomide are given together, they decrease the amount of a certain protein, allowing the tumor cells to be more easily killed. Thalidomide is a drug that alters the immune system. it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may decrease or prevent the growth of cancer cells.

If you are found to be eligible to take part in this study, you will begin treatment. All 3 drugs will be taken by mouth at home. Each treatment cycle will last for 8 weeks. You will take temozolomide once a day for 6 weeks followed by two weeks off. The best time to take temozolomide is around bedtime, since you must not eat for at least 1 hour before and 1 hour after taking it. The number of capsules you will take is based on your height and weight. You must swallow all the temozolomide capsules at the same time with 8 ounces of water (do not chew them).

You will take thalidomide every day for the entire 8-week cycle. Thalidomide should also be taken near bedtime, usually 30 to 45 minutes before the temozolomide dose. If you are under 70 years of age, you will start at a set dose and take the same dose throughout the study. If you are age 70 or over, the dose will start lower and will increase every 2 weeks until you are taking the prearranged set dose that those under the age of 70 are taking. Your doctor will be watching for side effects as the dose increases and may keep you at a lower dose if necessary.

In the first groups of patients (3-6 patients per group, total up to 18 patients) to be enrolled, each new group of participants will be given a higher dose of lomustine than the previous group until the highest safe dose of lomustine is found or until 18 patients have been enrolled. Responses to these doses will be evaluated. Once the best dose is found, all future participants will receive that dose of lomustine.

You will take 2 doses of lomustine every 8 weeks. You will take the first dose of lomustine on Day 1 of the 8-week cycle. You will take the second dose, which will be half as big as the first dose, on Day 29 (the day after the first 4 weeks) of the 8-week cycle. The dose of lomustine is also based on your height and weight. Lomustine should be swallowed and not chewed.

During treatment, every 2-4 weeks, you will have a complete physical exam and blood drawn for testing (1-2 tablespoons). These tests will let the doctor know if the treatment should be changed, briefly interrupted, or stopped. Women who are able to have children must have a negative pregnancy test every week for the first 4 weeks if they have regular menstruation and every 2 weeks if their periods are irregular.

At the end of 8 weeks, you will have x-rays or scans done again to see how the tumors have responded. If they are the same size or have gotten smaller, you may continue the treatment. You may stay on treatment as long as you are not having severe side effects and your tumor is either staying the same size or getting smaller. Treatment will be stopped if the tumors are getting bigger.

If you are withdrawn from the study for any reason you will be contacted by phone every three months to learn how are you doing health wise.

This is an investigational study. None of the 3 drugs used in this study have been approved by the FDA for the treatment of melanoma. Temozolomide has been approved for the treatment of brain cancer. Thalidomide has not yet been approved for the treatment of cancer. Lomustine is approved for the treatment of brain tumors and Hodgkin's disease. All of the drugs are commercially available. Their use together in this study is experimental.

Up to 18 patients will take part in this Phase I portion of the study, and another 30 patients in Phase II if progresses, with up to 48 patients total. All will be enrolled at M. D. Anderson. ;

Related Conditions & MeSH terms

• Brain Neoplasms
• Melanoma

• NCT number: NCT00527657
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 1
• Start date: February 9, 2006
• Completion date: February 2, 2012