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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00006200 |
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Date of registration:
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09/09/2000 |
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Primary sponsor: |
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Public title:
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Thalidomide and Dacarbazine for Metastatic Melanoma
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Scientific title:
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Date of first enrolment:
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August 2000 |
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Target sample size:
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00006200 |
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Study type:
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Interventional |
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Study design:
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Primary Purpose: Treatment
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Melanoma
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Intervention(s)
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Drug: dacarbazine
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Drug: thalidomide
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Secondary ID(s)
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M01RR00096
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NCRR-M01RR00096-1000
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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