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Vaccine Therapy in Treating Patients With Metastatic Melanoma

Primary Purpose

Melanoma (Skin)

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
sargramostim
vaccinia-GM-CSF vaccine
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically proven melanoma that is considered surgically incurable Dermal, subcutaneous, or lymph node metastases required At least 3 lesions evaluable and accessible for injection and biopsy One lesion at least 10 mm in diameter No leukemia or lymphoma PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 6 months Hematopoietic: Not specified Hepatic: Bilirubin no greater than 3 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 3 times ULN Immunologic: Clinical evidence of immune response required within 4 days of smallpox vaccination At least 1 positive cutaneous delayed-type hypersensitivity response to 1 of the following: Microbial recall antigens Dinitrofluorobenzene after sensitization Purified protein derivative of tuberculin following BCG vaccination No altered immunocompetence (e.g., immune deficiency disease or immunosuppressive therapy) in patient or household contacts No allergy to any of the following: Polymyxin B sulfate Streptomycin sulfate Chlortetracycline hydrochloride Neomycin sulfate No history of eczema or other exfoliative skin conditions in patient or household contacts HIV negative Other: No other malignancy within the past 3 years except superficial squamous cell or basal cell skin cancer or carcinoma in situ of the cervix or prostate Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 8 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: No concurrent or imminent steroid therapy Radiotherapy: At least 8 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior surgery

Sites / Locations

  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
January 9, 2014
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002817
Brief Title
Vaccine Therapy in Treating Patients With Metastatic Melanoma
Official Title
INTRALESIONAL IMMUNOTHERAPY WITH A VACCINIA/GM-CSF RECOMBINANT VIRUS IN PATIENTS WITH METASTATIC MELANOMA
Study Type
Interventional

2. Study Status

Record Verification Date
May 2002
Overall Recruitment Status
Unknown status
Study Start Date
April 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Vaccines may make the body build an immune response to kill melanoma cells. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients with metastatic melanoma.
Detailed Description
OBJECTIVES: I. Determine the toxicity of intralesional immunotherapy with a recombinant vaccinia virus encoding the gene for sargramostim (GM-CSF) in patients with metastatic melanoma. II. Determine the efficiency of viral infection and GM-CSF gene insertion and function in these patients. III. Determine the capacity of this regimen to generate antiviral and antitumor immunity in these patients. IV. Determine the frequency of regression of injected and uninjected lesions in these patients. OUTLINE: This is a dose-escalation study of intralesional recombinant vaccinia virus encoding the gene for sargramostim (GM-CSF) (rV-GM-CSF). Patients are stratified by center. Patients receive small pox (vaccinia) vaccine via multipuncture technique on day 0. On day 4, patients with a progressive major reaction to the initial vaccination receive rV-GM-CSF intralesionally twice weekly for 5 weeks. Only 1 lesion is treated and at least 1 measurable lesion is left untreated in each patient. Patients with responding disease after week 5 are retreated at a clinically appropriate dose and schedule. Cohorts of 5 patients receive escalating doses of intralesional rV-GM-CSF until the maximum tolerated dose (MTD) is determined. Additional patients receive rV-GM-CSF at the MTD. PROJECTED ACCRUAL: Approximately 30 patients (15 for each phase) will be accrued for this study.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
sargramostim
Intervention Type
Biological
Intervention Name(s)
vaccinia-GM-CSF vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven melanoma that is considered surgically incurable Dermal, subcutaneous, or lymph node metastases required At least 3 lesions evaluable and accessible for injection and biopsy One lesion at least 10 mm in diameter No leukemia or lymphoma PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: At least 6 months Hematopoietic: Not specified Hepatic: Bilirubin no greater than 3 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 3 times ULN Immunologic: Clinical evidence of immune response required within 4 days of smallpox vaccination At least 1 positive cutaneous delayed-type hypersensitivity response to 1 of the following: Microbial recall antigens Dinitrofluorobenzene after sensitization Purified protein derivative of tuberculin following BCG vaccination No altered immunocompetence (e.g., immune deficiency disease or immunosuppressive therapy) in patient or household contacts No allergy to any of the following: Polymyxin B sulfate Streptomycin sulfate Chlortetracycline hydrochloride Neomycin sulfate No history of eczema or other exfoliative skin conditions in patient or household contacts HIV negative Other: No other malignancy within the past 3 years except superficial squamous cell or basal cell skin cancer or carcinoma in situ of the cervix or prostate Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 8 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: No concurrent or imminent steroid therapy Radiotherapy: At least 8 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J. Mastrangelo, MD
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Study Chair
Facility Information:
Facility Name
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5541
Country
United States

12. IPD Sharing Statement

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Vaccine Therapy in Treating Patients With Metastatic Melanoma

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