Thalidomide and Dacarbazine for Metastatic Melanoma

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2004 by National Center for Research Resources (NCRR). Recruitment status was Active, not recruiting

First Received on September 9, 2000. Last Updated on 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:	Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Thalidomide Dacarbazine

U.S. FDA Resources

Further study details as provided by National Center for Research Resources (NCRR):

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

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

Additional relevant MeSH terms:

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Dacarbazine
Thalidomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on February 12, 2012