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INTRALESIONAL IMMUNOTHERAPY WITH A VACCINIA/GM-CSF RECOMBINANT VIRUS IN PATIENTS WITH METASTATIC MELANOMA


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Melanoma (Skin)

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Trial Information

INTRALESIONAL IMMUNOTHERAPY WITH A VACCINIA/GM-CSF RECOMBINANT VIRUS IN PATIENTS WITH METASTATIC MELANOMA


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Michael J. Mastrangelo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kimmel Cancer Center (KCC)

Authority:

United States: Federal Government

Study ID:

CDR0000064975

NCT ID:

NCT00002817

Start Date:

April 1996

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location

Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107