Thalidomide and Dacarbazine for Metastatic Melanoma

This study is ongoing, but not recruiting participants.

First Received: September 9, 2000 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00006200

Purpose

The purpose of this clinical trial is to assess the activity of thalidomide in combination with dacarbazine (DTIC) in patients with metastatic melanoma. Safety and toxicity of the two drugs will also be assessed. Dacarbazine is the standard medical treatment for metastatic melanoma. It has been shown to produce tumor shrinkage in approximately 20% of patients with advanced melanoma. This shrinkage is usually incomplete and lasts a short time. Thalidomide is a drug that inhibits tumor blood vessel growth. It can be given orally. It is hoped that this combination can be given to patients with metastatic melanoma without causing too much toxicity while increasing the response rate.

Condition	Intervention	Phase
Melanoma	Drug: thalidomide Drug: dacarbazine	Phase II

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Thalidomide Dacarbazine

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with metastatic melanoma.
Lesions must be measurable.
Patient must have the following minimum labs: ANC> 1500/mm3, Hemoglobin > 8 mg/dl; platelets > 100,000 mm3; and liver function tests < 5x normal; and creatinine < 1.5 mg/dl.
ECOG performance status > 2.
No prior therapy with DTIC or thalidomide
No other history of malignancy other than curatively resected basal cell carcinoma of the skin or carcinoma in situ of the cervix.
Patients must not be pregnant or lactating.
Sexually active men and women of childbearing age must use adequate contraception. All patients must understand the potential for severe birth defects with thalidomide and must be able to follow instructions to avoid conception while taking thalidomide

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006200

Locations

United States, New York
Kaplan Comprehensive Cancer Center
New York, New York, United States, 10016

Sponsors and Collaborators

National Center for Research Resources (NCRR)

More Information

No publications provided

Study ID Numbers:	NCRR-M01RR00096-1000, M01RR00096
Study First Received:	September 9, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00006200 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Anti-Infective Agents
Dacarbazine
Molecular Mechanisms of Pharmacological Action
Thalidomide
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Melanoma
Anti-Bacterial Agents
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Nevi and Melanomas

Growth Inhibitors
Angiogenesis Modulating Agents
Alkylating Agents
Neoplasms by Histologic Type
Growth Substances
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Antineoplastic Agents, Alkylating
Leprostatic Agents

ClinicalTrials.gov processed this record on November 30, 2009