Advertisement

Topics

Taxotere/Temodar/Cisplatin Study in Melanoma Patients

2014-08-27 03:36:15 | BioPortfolio

Summary

Primary Objective:

1. To determine the maximum tolerated dose of chemotherapy using Taxotere, Temodar, Cisplatin (TTC) in patients with metastatic melanoma.

Secondary Objectives:

1. To determine the toxicity of chemotherapy using Taxotere, Temodar, Cisplatin (TTC) in patients with metastatic melanoma

2. To determine the response rate of induction chemotherapy using Taxotere, Temodar, Cisplatin (TTC) in patients with metastatic melanoma.

Description

Temozolomide, docetaxel, and cisplatin are "chemotherapy" drugs, known to kill tumor cells by interfering with the important structures in these cells to grow and divide. Each of these drugs has been used separately for melanoma treatment. These 3 drugs have not been used in combination.

Before you can start treatment on the study, you will have what are called "screening tests". These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete medical history and physical exam, including routine blood tests (less than 3 tablespoons). You will have an electrocardiogram (EKG - test to measure the electrical activity of the heart), a chest x-ray, and CT scans of the chest and abdomen. You will have a MRI or CT scan of brain will as well. Depending on the location of melanoma, CT scans of the head and neck or pelvis and/or a bone scan may be taken. Photographs of the tumor may be taken if the tumors are located on the surface of the skin. Women who are able to have children must have a negative blood pregnancy test.

If you are found to be eligible, you will receive temozolomide, cisplatin, and docetaxel. The doses of temozolomide and cisplatin will be fixed for all groups. The dose of docetaxel will be changed between patient groups until the highest safe dose is found Between 3 and 6 patients will be enrolled in each group. Docetaxel will be given by vein over 1 hour, once a week, for three weeks (on Days 1, 8, and 15). This will be followed by one week of rest. These 3 weeks of treatment and 1 week or rest make up 1 cycle. Cisplatin will be given by vein once a day for four days in a row (Days 1, 2, 3 and 4) over 2 hours each cycle. Temozolomide will be taken by mouth for five days in a row (Days 1, 2, 3, 4 and 5) of each cycle. The number of temozolomide pills that you take will be based on your height and weight. Temozolomide must be taken on an empty stomach (at least 2 hours before or after meals).

For your comfort in receiving cisplatin and docetaxel by vein, your doctor may recommend a catheter. A catheter is a plastic tube that is inserted into a vein in one of your arms or into the vein that runs underneath the collar bone, and then threaded into the central vein in the upper part of the chest.

The first dose of docetaxel and all of the cisplatin doses must be given at M.D. Anderson on an outpatient basis. All of the temozolomide doses can be taken at home and the Day 8 and Day 15 doses of docetaxel can be taken at a local clinic.

You may receive granulocyte colony-stimulating factor (G-CSF) to help the body produce new blood cells. G-CSF would be given as an injection under the skin on Days 9-13 of each cycle (except the first cycle).

During the study, you will have a complete physical exam every 4 weeks. Blood samples (1 tablespoon or less) will be taken weekly to monitor the blood counts and liver functions. A chest x-ray and CT scans of the chest and abdomen with or without head and neck and pelvis will be done every 2 cycles (8 weeks). A MRI or CT scan of the brain as well as photographs may also be taken every 2 cycles during the study. For patients who have significant tumor shrinkage with the treatment, these imaging studies may be repeated in 4 weeks.

All participants can receive at least 6 cycles of treatment. If your tumor continues to shrink after the end of 6 cycles, you may be eligible to receive further treatment at the discretion of the study chair. You may be taken off study early, if your disease gets worse or intolerable side effects occur.

You will have one last "follow-up" visit once you are taken off study. At this visit you will have a complete physical exam and blood samples (1 tablespoon) for routine tests will be taken. You will have a chest x-ray and CT scans of the chest and abdomen, with or without head and neck and pelvis, and with or without a MRI of brain at this visit as well.

This is an investigational study. The FDA has approved all of the drugs in this study, and they are commercially available. However, their use together in this study is experimental. Up to 30 patients will take part in this study. All will be enrolled at M.D. Anderson.

Study Design

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

Conditions

Metastatic Melanoma

Intervention

Cisplatin, Docetaxel, Temodar

Location

U.T.M.D. Anderson Cancer Center
Houston
Texas
United States
77030

Status

Completed

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:36:15-0400

Clinical Trials [3122 Associated Clinical Trials listed on BioPortfolio]

Biochemotherapy With Temozolomide for Metastatic Melanoma

The goal of this clinical research study is to learn if treatment with Temodar (temozolomide), Velban (vinblastine), Cisplatin, Proleukin (interleukin-2), Intron-A (interferon alpha), and ...

Temodar and Sutent as Therapy for Melanoma

This study is designed to evaluate the safety and appropriate dose of the combination of Temodar and Sutent as first-line therapy for patients with metastatic malignant melanoma (Phase 1)....

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

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 thr...

IPI Biochemotherapy for Chemonaive Patients With Metastatic Melanoma

The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of the drug Yervoy (ipilimumab) that can be given with the drugs Temodar (temozolomide), ...

Docetaxel Versus Docetaxel Plus Cisplatin Versus Docetaxel Plus S-1 as Second-line Chemotherapy in Metastatic Gastric Cancer

The purpose of this study is to assess efficacy and safety of docetaxel alone, docetaxel plus cisplatin, and docetaxel plus S-1 in patients with metastatic gastric cancer after failing 1st...

PubMed Articles [2586 Associated PubMed Articles listed on BioPortfolio]

Phase I/II Trial of Chemotherapy with Docetaxel, Cisplatin, and S-1 for Unresectable Advanced Squamous Cell Carcinoma of the Esophagus.

Our previous trial with a docetaxel, cisplatin, and 5-fluorouracil (DCF) regimen showed high response rates in metastatic squamous cell carcinoma of the esophagus (SCCE). The observed increased toxici...

Robot-assisted laparoscopic surgery for abdominal metastatic melanoma mimicking a gastrointestinal stromal tumor: A case report and review of the literature.

Uveal melanoma is the most common primary intraocular malignancy, which could metastasize at an early stage of the disease and associated with poor prognoses. Liver, small bowel, stomach, and colon ar...

Combined Nivolumab and Ipilimumab in Melanoma Metastatic to the Brain.

Brain metastases are a common cause of disabling neurologic complications and death in patients with metastatic melanoma. Previous studies of nivolumab combined with ipilimumab in metastatic melanoma ...

Resorcinolic lipid 3-heptyl-3,4,6-trimethoxy-3H-isobenzofuran-1-one is a strategy μfor melanoma treatment.

Previous studies performed by our research group indicated that cytosporone analogues are capable of prevent or repair DNA damages. This work presents the evaluation of the activity of AMS35AA for met...

How to MEK the best of uveal melanoma: A systematic review on the efficacy and safety of MEK inhibitors in metastatic or unresectable uveal melanoma.

BRAF and MEK inhibitors have demonstrated significant survival benefits for patients with cutaneous melanoma. However, their use for uveal melanoma (UM) is less established. The aim of this systematic...

Medical and Biotech [MESH] Definitions

An unpigmented malignant melanoma. It is an anaplastic melanoma consisting of cells derived from melanoblasts but not forming melanin. (Dorland, 27th ed; Stedman, 25th ed)

An inorganic and water-soluble platinum complex. After undergoing hydrolysis, it reacts with DNA to produce both intra and interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity of cisplatin correlates with cellular arrest in the G2 phase of the cell cycle.

An anti-CTLA-4 ANTIGEN monoclonal antibody initially indicated for the treatment of certain types of metastatic MELANOMA. Its mode of actions may include blocking of CTLA-4 mediated inhibition of CYTOTOXIC T LYMPHOCYTES, allowing for more efficient destruction of target tumor cells.

Experimentally induced tumor that produces MELANIN in animals to provide a model for studying human MELANOMA.

A cellular subtype of malignant melanoma. It is a pigmented lesion composed of melanocytes occurring on sun-exposed skin, usually the face and neck. The melanocytes are commonly multinucleated with a "starburst" appearance. It is considered by many to be the in situ phase of lentigo maligna melanoma.

More From BioPortfolio on "Taxotere/Temodar/Cisplatin Study in Melanoma Patients"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Prostate Cancer
Prostate cancer (cancer de prostata) Prostate cancer (cancer de prostata) is a form of cancer that develops in the prostate, a gland in the male reproductive system. Most prostate cancers are slow growing; however, there are cases of aggressive prostat...

Cancer
  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

Melanoma
Melanoma is a highly malignant tumor of melanin-forming cells (melanocytes) There are most commonly found in the skin (resulting from sunlight exposure), but also in the eyes and mucous membranes. Metastasis to other regions of the body is also common....


Searches Linking to this Trial