Vaccine Therapy in Treating Patients With Metastatic Melanoma
|ClinicalTrials.gov Identifier: NCT00019734|
Recruitment Status : Completed
First Posted : May 28, 2003
Last Update Posted : June 20, 2013
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy with and without interleukin-2 in treating patients who have metastatic melanoma that has not responded to previous treatment.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: aldesleukin Biological: fowlpox virus vaccine vector Biological: vaccinia-tyrosinase vaccine||Phase 2|
- Determine efficacy of recombinant fowlpox and vaccinia viruses encoding tyrosinase antigen, administered with or without low-dose interleukin-2 (IL-2), in terms of response, in patients with metastatic melanoma.
- Compare the response rate in patients to this vaccination administered with high-dose IL-2 to that in similar patients on previous trials treated with high-dose IL-2 alone.
- Determine the immunological response in patients treated with this regimen.
OUTLINE: This is a randomized study. Patients are randomized to one of three treatment arms.
- Arm I: Patients receive recombinant fowlpox vaccine IM on day 1 followed 4 weeks later by recombinant vaccinia vaccine IM. Treatment repeats for a minimum of 4 vaccinations.
- Arm II: Patients receive vaccinations as in arm I plus low-dose interleukin-2 (IL-2) subcutaneously daily on days 2-13 after each vaccination.
- Arm III: Patients receive vaccinations as in arm I plus high-dose IL-2 IV over 15 minutes every 8 hours on days 2-5 after each vaccination.
Patients with stable disease or a minor, mixed, or partial response after four immunizations (1 course) may receive a second course of the same regimen beginning 4-6 weeks after the first course. After the second course, patients with tumor regression may continue to receive treatment in the absence of unacceptable toxicity until best response is achieved.
Patients are followed at 4-6 weeks.
PROJECTED ACCRUAL: A total of 73 patients (13-20 for arm I, 13-20 for arm II, and 19-33 for arm III) will be accrued for this study within 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Immunization of Patients With Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen|
|Study Start Date :||July 1999|
|Actual Study Completion Date :||May 2003|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00019734
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Suzanne L. Topalian, MD||NCI - Surgery Branch|