Thalidomide and Dacarbazine for Metastatic Melanoma

Melanoma Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00006200
• Other study ID #: NCRR-M01RR00096-1000
• Secondary ID: M01RR000096
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 9, 2000
• Last updated: June 23, 2005

Study information

• Verified date: January 2004
• Source: National Center for Research Resources (NCRR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• thalidomide

• dacarbazine

Locations

Country	Name	City	State
United States	Kaplan Comprehensive Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States,