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| Sponsored by: |
National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00054535 |
Purpose
RATIONALE: Vaccines may make the body build an immune response that will kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells.
PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with interleukin-2 in treating patients who have metastatic melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Biological: aldesleukin Biological: recombinant fowlpox-tyrosinase vaccine Biological: vaccinia-tyrosinase vaccine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Treatment Of Patients With Metastatic Melanoma Using Recombinant Vaccinia And Fowlpox Viruses Encoding The Tyrosine Antigen In Combination With Interleukin-2 |
| Study Start Date: | January 2003 |
OBJECTIVES:
OUTLINE: Patients receive vaccinia-tyrosinase vaccine intramuscularly (IM) on day 1 followed by fowlpox-tyrosinase vaccine IM on days 15 and 29. Patients then receive high-dose interleukin-2 (IL-2) IV over 15 minutes every 8 hours beginning on day 30 for up to 12 doses and again beginning approximately 3 weeks after the initial dose. Patients with stable disease or a minor, mixed, or partial response may receive additional courses of fowlpox-tyrosinase vaccine (2 doses) and IL-2 as above in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 1 additional course beyond achieving CR.
Patients are followed annually for at least 5 years.
PROJECTED ACCRUAL: A total of 19-35 patients will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of metastatic melanoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
Other
No close contact with the following individuals for 2 weeks after vaccinia vaccination:
No active cases of the following conditions:
No unhealed surgical scars
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior vaccination with full length tyrosinase protein, or a vector encoding the full length protein for melanoma
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | Suzanne L. Topalian, MD | NCI - Surgery Branch |
More Information
| Study ID Numbers: | CDR0000270794, NCI-03-C-0080, NCI-6119 |
| Study First Received: | February 5, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00054535 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV melanoma recurrent melanoma |
|
Anti-HIV Agents Vaccinia Tyrosine Antiviral Agents Recurrence Melanoma Neuroendocrine Tumors Virus Diseases Neuroectodermal Tumors Aldesleukin |
Anti-Retroviral Agents Analgesics, Non-Narcotic Interleukin-2 Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Peripheral Nervous System Agents Nevus Analgesics |
|
Anti-Infective Agents Anti-HIV Agents Neoplasms by Histologic Type Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Antiviral Agents Pharmacologic Actions Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms |
Aldesleukin Anti-Retroviral Agents Sensory System Agents Analgesics, Non-Narcotic Interleukin-2 Neoplasms, Germ Cell and Embryonal Therapeutic Uses Nevi and Melanomas Peripheral Nervous System Agents Analgesics Central Nervous System Agents |