Vaccine Therapy and Interleukin-2 in Treating Patients With Metastatic Melanoma
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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 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| 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:
- Determine the response rate (partial response or complete remission) in patients with metastatic melanoma treated with vaccinia-tyrosinase vaccine, fowlpox-tyrosinase vaccine, and high-dose interleukin-2.
- Determine the immunologic response, measured by the reactivity of CD4+ and CD8+ T cells and serum immunoglobulins against tyrosinase and melanoma cells, in patients treated with this regimen.
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
- Measurable disease
- Disease progression while receiving prior standard treatment
- No ocular or mucosal primary site
- No uncontrolled brain metastases
PATIENT CHARACTERISTICS:
Age
- 16 and over
Performance status
- ECOG 0-1
Life expectancy
- More than 3 months
Hematopoietic
- WBC at least 3,000/mm^3
- Platelet count at least 90,000/mm^3
- No coagulation disorders
Hepatic
- Bilirubin no greater than 1.6 mg/dL (less than 3.0 mg/dL in patients with Gilbert's syndrome)
- AST/ALT less than 3 times normal
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
Renal
- Creatinine no greater than 1.6 mg/dL
Cardiovascular
- No major cardiovascular illness
Pulmonary
- No major respiratory illness
Immunologic
- HIV negative
- No autoimmune disease
- No active systemic infections
- No primary or secondary immunodeficiency (e.g., hereditary disorders such as ataxia-telangiectasia or Wiskott-Aldrich syndrome or acquired immunodeficiencies after bone marrow transplantation)
- No allergy to eggs
- No prior allergy or untoward reaction to smallpox vaccination (if previously vaccinated)
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
No close contact with the following individuals for 2 weeks after vaccinia vaccination:
- Children under 5 years of age
- Pregnant women
- Individuals with prior or active eczema or other eczematoid skin disorders
- Individuals with other acute, chronic, or exfoliative skin conditions (e.g., burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
- Immunosuppressed individuals
- No active atopic dermatitis
- No prior or active eczema
No active cases of the following conditions:
- Extensive psoriasis
- Severe acneiform rash
- Impetigo
- Varicella zoster
- Burns
- Traumatic or pruritic skin conditions
- Open wounds
No unhealed surgical scars
- Healed surgical stomas (e.g., colostomy) allowed
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior recombinant vaccinia or fowlpox vaccines for melanoma
No prior vaccination with full length tyrosinase protein, or a vector encoding the full length protein for melanoma
- Prior individual tyrosinase peptides are allowed
- No prior high-dose interleukin-2
Chemotherapy
- Not specified
Endocrine therapy
- No concurrent oral, IV, topical, or inhaled steroids
Radiotherapy
- Not specified
Surgery
- Recovered from prior surgery
Other
- Recovered from prior therapy for melanoma
- More than 3 weeks since prior systemic therapy for melanoma
- No other concurrent systemic therapy for melanoma
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
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00054535 History of Changes |
| Obsolete Identifiers: | NCT00051610 |
| Other Study ID Numbers: | CDR0000270794, NCI-03-C-0080, NCI-6119 |
| Study First Received: | February 5, 2003 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV melanoma recurrent melanoma |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Aldesleukin Interleukin-2 Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 22, 2013