- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00019669
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
Immunization of Patients With Metastatic Melanoma Using a Recombinant Fowlpox Virus Encoding a GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether combining melanoma vaccine with interleukin-2 is more effective than vaccine therapy alone in treating metastatic melanoma.
PURPOSE: Phase II trial to compare the effectiveness of melanoma vaccine and interleukin-2 with that of melanoma vaccine alone in treating patients who have metastatic melanoma that has not responded to previous treatment.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Compare the clinical response in patients with metastatic melanoma treated with immunization with recombinant fowlpox vaccine administered either intravenously or intramuscularly, with or without interleukin-2 (IL-2).
- Compare the immune response in patients before and after treatment with these regimens.
- Compare the toxicity profile of these regimens in these patients.
OUTLINE: This is a partially randomized study. Patients are randomized to 1 of 3 treatment cohorts.
- Cohort 1: Patients receive recombinant fowlpox virus encoding gp100 peptide (fowlpox vaccine) IV once every 4 weeks for up to 4 doses. (Closed to accrual as of 6/21/02.)
- Cohort 2: Patients receive fowlpox vaccine intramuscularly (IM) once every 4 weeks for up to 4 doses. (Closed to accrual as of 6/21/04.)
- Cohort 3 (for patients in need of immediate interleukin-2 [IL-2] and those with disease progression after treatment in cohorts 1 or 2): Patients receive fowlpox vaccine either IV or IM* once every 4 weeks for 4 doses and IL-2 IV every 8 hours for a maximum of 12 doses beginning 24 hours after fowlpox vaccine.
NOTE: *The IM route of administration was selected as the preferred route of administration from cohorts 1 and 2
- Expanded cohort 2 (open to accrual 7/19/02): Patients receive fowlpox vaccine IM once every 4 weeks for up to 4 doses. Upon disease progression, patients receive fowlpox vaccine as above and IL-2 IV every 8 hours for a maximum of 12 doses beginning 24 hours after fowlpox vaccine. (Closed to accrual 12/4/03.) In all cohorts, 3-4 weeks after the last injection, patients achieving a complete remission may receive a maximum of an additional 2 courses of therapy. Patients with responding disease may receive repeat vaccinations for up to 8 courses. Patients with no response or progressive disease in cohorts not receiving IL-2 may be treated with fowlpox vaccine and IL-2 as in cohort 3. Patients who are randomized to receive IL-2 may not receive additional IL-2 therapy.
PROJECTED ACCRUAL: A maximum of 84 patients (24 in cohorts 1 and 2, 19-33 in cohort 3, and 27 in expanded cohort 2) will be accrued for this study within 1 year.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically proven metastatic melanoma that has failed standard treatment
- Measurable disease
- HLA-A-201 positive
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- ECOG 0-2
Life expectancy:
- More than 3 months
Hematopoietic:
- WBC ≥ 3,000/mm^3
- Platelet count ≥ 90,000/mm^3
- No coagulation disorders
Hepatic:
- Bilirubin ≤ 1.6 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome)
- AST/ALT < 2 times normal
- Hepatitis B surface antigen negative
Renal:
- Creatinine ≤ 2.0 mg/dL
Cardiovascular:
- No major cardiovascular disease
- No cardiac ischemia by a stress thallium test or other comparable test*
- No myocardial infarction*
- No cardiac arrhythmias* NOTE: *In order to be eligible to receive interleukin-2 (IL-2)
Pulmonary:
- No major respiratory disease
- No obstructive or restrictive pulmonary disease* NOTE: *In order to be eligible to receive IL-2
Immunologic:
- No autoimmune disease
- No known immunodeficiency disease
- No primary or secondary immunodeficiency
- No allergy to eggs
- No active systemic infections
- HIV negative
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other active major medical illness* NOTE: *In order to be eligible to receive IL-2
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior gp100 vaccination
Chemotherapy:
- Not specified
Endocrine therapy:
- No concurrent steroids
Radiotherapy:
- Not specified
Surgery:
- Prior surgery for the malignancy allowed
Other:
- At least 3 weeks since other prior therapy for the malignancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000066961
- NCI-99-C-0044
- NCI-T98-0088
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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