Thalidomide and Dacarbazine for Metastatic Melanoma

NCT00006200 | Unknown Phase 2

• 2 other identifiers: NCRR-M01RR00096-1000M01RR000096
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melanoma

Interventions

thalidomide DRUG

dacarbazine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead

Study Sites (1)

Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Thalidomide; Dacarbazine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Triazenes; Imidazoles; Azoles

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 9, 2000
• First Posted: September 11, 2000
• Last Updated: June 24, 2005

Record last verified: 2004-01

Locations

US (1)