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Thalidomide and Dacarbazine for Metastatic Melanoma



Thalidomide and Dacarbazine for Metastatic Melanoma

For Condition: Melanoma
Status: Recruiting
Sponsor(s): National Center for Research Resources (NCRR) ,
Synopsis: 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.
Details:
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Kaplan Comprehensive Cancer Center *Recruiting*
New York City,  New York,  10016
United States
Recruiting Madeline  Peyton 212-263-6485


Additional Information:
Study ID Numbers:  NCRR-M01RR00096-1000;  M01RR00096
Study Start Date: 
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006200

Other Melanoma Studies:
1. Pilot Study of a Double Isolation Perfusion Schedule Using Melphalan Alone for Intransit Melanoma or Unresectable Sarcoma of the Extremity

2. Comparison Study of MDX-010 (CTLA-4) Alone and Combined with DTIC in the Treatment of Metastatic Melanoma

3. A Phase I Study of Intralesional Administration of an Adenovirus Vector Expressing the HSV-1 Thymidine Kinase Gene (AdV.RSV-TK) in Combination with Escalating Doses of Ganciclovir in Patients with Cutaneous Metastatic Malignant Melanoma

4. A Phase II Protocol of Flt3 Ligand in Patients with Metastatic Melanoma and Renal Cancer

5. A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion with Melphalan, Tumor Necrosis Factor, and Interferon-Gamma in Patients with Locally Advanced Extremity Melanoma

Related Studies:

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