Adjuvant, Combined Interleukin 2 (Proleukin) and DTIC (Dacarbazine) in High-risk Melanoma Patients (DTIC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00553618|
Recruitment Status : Active, not recruiting
First Posted : November 5, 2007
Last Update Posted : November 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma||Drug: Proleukin and Dacarbazine||Phase 2|
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 In unpublished results, forty-two stage II and III melanoma patients were treated with this regimen at the University of Alabama with IRB approval.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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||August 2007|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||August 2022|
Experimental: Proleukin/DTIC Arm
Adjucant proleukin and DTIC
Drug: Proleukin and Dacarbazine
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.
Other Name: Proleukin, Dacarbazine
- Relapse-free survival [ Time Frame: The study duration is projected to be approximately 9 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553618
|United States, Kentucky|
|James Graham Brown Cancer Center|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Jason A Chesney, MD||James Graham Brown Cancer Center, University of Louisville|