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A Phase I Study Using Direct Combination DNA Injections for the Immunotherapy of Metastatic Melanoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

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Trial Information

A Phase I Study Using Direct Combination DNA Injections for the Immunotherapy of Metastatic Melanoma


OBJECTIVES: I. Determine the maximum tolerated dose of liposome complexed staphylococcal
enterotoxin B and interleukin-2 plasmid DNA in patients with metastatic melanoma. II.
Determine local gene expression in tumor tissues in this patient population treated with
this regimen. III. Determine if plasmid DNA can be detected in circulation following
intratumoral injection of this regimen in this patient population. IV. Evaluate the
antitumor immune responses induced by this treatment regimen in these patients. V.
Characterize the clinical response to this treatment regimen in terms of tumor size and
histology in these patients. VI. Determine the clinical response to this treatment regimen
in terms of complete remission, partial remission, stable disease, and disease progression
in these patients.

OUTLINE: This is a dose escalation study. Patients receive intratumoral liposome complexed
staphylococcal enterotoxin B (SEB) and interleukin-2 (IL-2) plasmid DNA injections into 1-3
tumor nodules once every 2 weeks. Treatment continues for 6 courses in the absence of
disease progression or unacceptable toxicity. Patients with complete regression during
therapy may receive additional therapy to previously untreated tumor nodules. Patients with
partial response at 4 weeks following the last injection may continue therapy once every 4
weeks until no residual tumor remains. Cohorts of 3 patients each receive escalating doses
of SEB and IL-2 plasmid DNA until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose at which at least 2 of 6 patients experience dose limiting toxicities.
Patients are followed until death.

PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed metastatic melanoma unresponsive to
standard therapy or for which no curative therapy exists No primary ocular melanoma At
least one cutaneous metastatic lesion measuring at least 1 cm in diameter No untreated
brain metastases by MRI or CT scan

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: SWOG 0-1 Life expectancy:
Greater than 2 months Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater
than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL No active, acute, or chronic
hepatitis Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No unstable angina or
complicated cardiovascular disease that would preclude catheterization Immunologic: No
active autoimmune disease or infection Peripheral blood mononuclear cell proliferative
response to 1 microgram/mL staphylococcal enterotoxin B in vitro, with a stimulation index
of at least 5 Other: HIV negative No uncontrolled diabetes mellitus No psychiatric illness
that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients
must use effective contraception No other malignancy except nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: See Disease Characteristics At least 4 weeks since other prior
anticancer therapy No concurrent glucocorticosteroids

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Patrick Walsh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Federal Government

Study ID:

95-0526.cc

NCT ID:

NCT00005943

Start Date:

February 2000

Completion Date:

September 2001

Related Keywords:

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

Name

Location

University of ColoradoDenver, Colorado  80217