|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00505635 |
Purpose
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 thalidomide can help to control melanoma that has spread to other parts of the body. The safety of this treatment will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma |
Drug: Temozolomide Drug: Velban Drug: Cisplatin Drug: Interleukin-2 Drug: Intron-A Drug: Thalidomide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Biochemotherapy With Temozolomide, Velban, Cisplatin, Interleukin-2, Interferon-alpha and Thalidomide for Metastatic Melanoma With Optional Intrathecal Interleukin-2 Treatment |
| Enrollment: | 5 |
| Study Start Date: | March 2007 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Biochemotherapy with Temozolomide
Temozolomide + Biochemotherapy of Velban + Cisplatin + Interleukin-2 + Intron-A + Thalidomide
|
Drug: Temozolomide
250 mg/m^2 By Mouth Every 4 Hours x 3 Doses On Day 1
Other Name: Temodar
Drug: Velban
1.5 mg/m^2 By Vein Over 15-30 Minutes On Days 1-4
Other Name: Vinblastine
Drug: Cisplatin
20 mg/m^2 By Vein Over 45-120 Minutes On Days 1-4
Other Names:
Drug: Interleukin-2
9 MIU/m^2 By Vein Over 24 Hours x 4 Doses On Days 1-4
Other Names:
Drug: Intron-A
5 mu/m^2 Subcutaneously (Under the skin) Daily On Days 1-5
Other Name: Interferon Alpha-2b
Drug: Thalidomide
400 mg By Mouth Daily
Other Name: Thalomid
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Nicholas E. Papadopoulos, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Nicholas E. Papadopoulos, MD/Professor, U.T.M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00505635 History of Changes |
| Other Study ID Numbers: | DM03-0218 |
| Study First Received: | July 20, 2007 |
| Last Updated: | April 9, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Melanoma Temozolomide Velban Vinblastine Cisplatin Interleukin-2 |
Intron-A Interferon Alpha-2b Thalidomide Thalomid Temodar Proleukin |
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Interferon-alpha Interferon Alfa-2a Interferon Alfa-2b Interferons Aldesleukin Thalidomide Temozolomide |
Cisplatin Interleukin-2 Vinblastine Dacarbazine Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |