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Sponsored by: |
James Graham Brown Cancer Center |
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Information provided by: | James Graham Brown Cancer Center |
ClinicalTrials.gov Identifier: | NCT00553618 |
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.
Condition | Intervention | Phase |
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Metastatic Melanoma |
Drug: Proleukin and Dacarbazine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Adjuvant Interleukin2 (Proleukin)and 5-(3,3 Dimethyl-1-Triazeno) Imidazone-4-Carboxamide (DTIC) in Resected High-Risk Primary and Regionally Metastatic Melanoma |
Estimated Enrollment: | 160 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | August 2011 |
Estimated Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
IL-2 (Proleukin), injected just under the skin, at a dose of 12 million units on days 1-4 for each of the six months of therapy.
Dacarbazine, administered as an IV infusion through a freely flowing IV, at a dose of 750 mg, repeated every four weeks.
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 In unpublished results, forty-two stage II and III melanoma patients were treated with this regimen at the University of Alabama with IRB approval.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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jason A Chesney, MD | 502-562-4370 | |
Contact: Bev S Taft, MSN | 502-562-3429 | bstaft01@gwise.louisville.edu |
United States, Kentucky | |
James Graham Brown Cancer Center | Recruiting |
Louisville, Kentucky, United States, 40202 | |
Contact: Bev S Taft, MSN 502-562-3429 bstaft01@gwise.louisville.edu | |
Contact: Kathleen K Rodger, RN, BSN, MSHCM 502-562-3429 kkrodg01@gwise.louisville.edu | |
Sub-Investigator: Kelly M McMasters, MD | |
Sub-Investigator: Donald M Miller, MD |
Principal Investigator: | Jason A Chesney, MD | James Graham Brown Cancer Center, University of Louisville |
Responsible Party: | James Graham Brown Cancer Center ( Jason A. Chesney, MD, PhD ) |
Study ID Numbers: | 07.0008 |
Study First Received: | November 1, 2007 |
Last Updated: | August 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00553618 History of Changes |
Health Authority: | United States: Institutional Review Board |
Interleukin 2 Proleukin DTIC |
Dacarbazine metastatic melanoma adjuvant |
Anti-HIV Agents Dacarbazine Adjuvants, Immunologic Antiviral Agents Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Aldesleukin Anti-Retroviral Agents Analgesics, Non-Narcotic |
Interleukin-2 Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Peripheral Nervous System Agents Analgesics Nevus Antineoplastic Agents, Alkylating Alkylating Agents |
Anti-Infective Agents Dacarbazine Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Melanoma Anti-Retroviral Agents Sensory System Agents Neoplasms, Germ Cell and Embryonal Therapeutic Uses Nevi and Melanomas Analgesics Alkylating Agents |
Neoplasms by Histologic Type Anti-HIV Agents Antiviral Agents Pharmacologic Actions Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Aldesleukin Interleukin-2 Analgesics, Non-Narcotic Antineoplastic Agents, Alkylating Peripheral Nervous System Agents Central Nervous System Agents |