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Spots Global Cancer Trial Database for Adjuvant, Combined Interleukin 2 (Proleukin) and DTIC (Dacarbazine) in High-risk Melanoma Patients

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Trial Identification

Brief Title: Adjuvant, Combined Interleukin 2 (Proleukin) and DTIC (Dacarbazine) in High-risk Melanoma Patients

Official Title: Adjuvant Interleukin2 (Proleukin)and 5-(3,3 Dimethyl-1-Triazeno) Imidazole-4-Carboxamide (DTIC) in Resected High-Risk Primary and Regionally Metastatic Melanoma

Study ID: NCT00553618

Study Description

Brief Summary: The purpose of this study is to see if the combination of the two cancer drugs, Dacarbazine (DTIC) and a low-dose of Proleukin (IL2), would provide a less toxic and more effective treatment for melanoma than currently available treatments for people with high-risk melanoma. Dacarbazine (DTIC) and Proleukin (IL2) are both FDA-approved drugs for the treatment of melanoma.

Detailed Description: The prognosis of patients with malignant melanomas that are greater than 4 mm deep or involve regional lymph nodes is poor, even after successful surgical removal. The concept of adjuvant therapy for melanoma is derived from the hypothesis that these therapies may kill micro-metastatic seeds of melanoma cells. The rationale for this particular drug combination regimen is that melanoma cells may act as a vaccine from which to generate melanoma-specific T cell expansion by way of IL2 administration. In unpublished results, forty-two stage II and III melanoma patients were treated with this regimen at the University of Alabama with IRB approval. Analysis of relapse free survival and overall survival in patients treated with this combination suggested a small improvement in disease-free survival when compared to historical controls or another study whose patients had similar but not identical staging (median follow-up time of 30 months). Importantly, no unanticipated side effects were observed as a result of the combination of these two drugs (both of which are FDA-approved for use in melanoma patients).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

James Graham Brown Cancer Center, Louisville, Kentucky, United States

Contact Details

Name: Jason A Chesney, MD

Affiliation: James Graham Brown Cancer Center, University of Louisville

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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