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Vaccine Therapy in Treating Patients With Metastatic Melanoma

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
fowlpox virus vaccine vector
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: Histologically confirmed metastatic melanoma that has failed standard treatment No ocular or mucosal melanoma as primary site Measurable disease No existing brain metastases PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0 or 1 Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 90,000/mm3 No coagulation disorder Hepatic: Bilirubin no greater than 1.6 mg/dL AST/ALT less than 3 times normal Hepatitis B surface antigen 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 primary or secondary immunodeficiency No allergy to eggs No history of allergy or untoward reaction to prior smallpox vaccination Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Must be able to avoid close contact with children under 5 years, pregnant women, people with active or a past history of eczema or other eczematoid skin disorders, and immunosuppressed people for at least 2 weeks after each vaccinia virus vaccination No active systemic infections No active atopic dermatitis or active or past history of eczema No concurrent active extensive psoriasis, severe acneiform rash, impetigo, varicella zoster, burns, or other traumatic or pruritic skin conditions or open wounds Surgical scars must be healed Healed surgical stomas (e.g., colostomy) allowed PRIOR CONCURRENT THERAPY: Biologic therapy: No prior recombinant vaccinia or fowlpox vaccines for melanoma At least 3 weeks since prior systemic biologic therapy for melanoma Chemotherapy: At least 3 weeks since prior systemic chemotherapy for melanoma Endocrine therapy: At least 3 weeks since prior systemic endocrine therapy for melanoma No concurrent steroid therapy Radiotherapy: At least 3 weeks since prior systemic radiotherapy for melanoma Surgery: Prior surgery allowed

Sites / Locations

  • Surgery Branch

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 11, 2001
Last Updated
June 19, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00019734
Brief Title
Vaccine Therapy in Treating Patients With Metastatic Melanoma
Official Title
Immunization of Patients With Metastatic Melanoma Using Recombinant Fowlpox and Vaccinia Viruses Encoding the Tyrosinase Antigen
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (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 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.
Detailed Description
OBJECTIVES: 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.

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
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Biological
Intervention Name(s)
fowlpox virus vaccine vector
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: Histologically confirmed metastatic melanoma that has failed standard treatment No ocular or mucosal melanoma as primary site Measurable disease No existing brain metastases PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0 or 1 Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 90,000/mm3 No coagulation disorder Hepatic: Bilirubin no greater than 1.6 mg/dL AST/ALT less than 3 times normal Hepatitis B surface antigen 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 primary or secondary immunodeficiency No allergy to eggs No history of allergy or untoward reaction to prior smallpox vaccination Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Must be able to avoid close contact with children under 5 years, pregnant women, people with active or a past history of eczema or other eczematoid skin disorders, and immunosuppressed people for at least 2 weeks after each vaccinia virus vaccination No active systemic infections No active atopic dermatitis or active or past history of eczema No concurrent active extensive psoriasis, severe acneiform rash, impetigo, varicella zoster, burns, or other traumatic or pruritic skin conditions or open wounds Surgical scars must be healed Healed surgical stomas (e.g., colostomy) allowed PRIOR CONCURRENT THERAPY: Biologic therapy: No prior recombinant vaccinia or fowlpox vaccines for melanoma At least 3 weeks since prior systemic biologic therapy for melanoma Chemotherapy: At least 3 weeks since prior systemic chemotherapy for melanoma Endocrine therapy: At least 3 weeks since prior systemic endocrine therapy for melanoma No concurrent steroid therapy Radiotherapy: At least 3 weeks since prior systemic radiotherapy for melanoma Surgery: Prior surgery allowed
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
Surgery Branch
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

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Vaccine Therapy in Treating Patients With Metastatic Melanoma

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