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Vaccine Therapy and Interleukin-2 in Treating Patients With Metastatic Melanoma

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
recombinant fowlpox-tyrosinase vaccine
vaccinia-tyrosinase vaccine
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, recurrent melanoma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 5, 2003
Last Updated
June 18, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00054535
Brief Title
Vaccine Therapy and Interleukin-2 in Treating Patients With Metastatic Melanoma
Official Title
Treatment Of Patients With Metastatic Melanoma Using Recombinant Vaccinia And Fowlpox Viruses Encoding The Tyrosine Antigen In Combination With Interleukin-2
Study Type
Interventional

2. Study Status

Record Verification Date
July 2004
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Biological
Intervention Name(s)
recombinant fowlpox-tyrosinase vaccine
Intervention Type
Biological
Intervention Name(s)
vaccinia-tyrosinase vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne L. Topalian, MD
Organizational Affiliation
NCI - Surgery Branch
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

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Vaccine Therapy and Interleukin-2 in Treating Patients With Metastatic Melanoma

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