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A Phase I Trial of Intra Lesional rV-Tricom Vaccine in the Treatment of Malignant Melanoma


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

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Trial Information

A Phase I Trial of Intra Lesional rV-Tricom Vaccine in the Treatment of Malignant Melanoma


OBJECTIVES:

- Determine the maximum tolerated dose of recombinant vaccinia-TRICOM vaccine in patients
with metastatic melanoma.

- Determine the clinical toxic effects of this vaccine in these patients.

- Determine the safety of this vaccine in these patients.

- Determine the clinical response of these patients to this vaccine.

- Determine evidence of host anti-melanoma immune reactivity in these patients after
treatment with this vaccine.

OUTLINE: This is a dose-escalation study.

Patients receive recombinant vaccinia-TRICOM vaccine once every 4 weeks for a total of 3
vaccinations. Patients with stable or responding disease may receive an additional course of
vaccinations.

Cohorts of 3-6 patients receive escalating doses of recombinant vaccinia-TRICOM vaccine
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Quality of life is assessed at baseline, at each vaccine administration, and at study
completion.

Patients are followed at 3 months.

PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study within 6-12
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic non-resectable cutaneous, subcutaneous, or lymph
node malignant melanoma

- Lesion(s) must be accessible to percutaneous injection

- Measurable lesion(s)

- At least 1.0 cm

- Previously treated brain metastases with no evidence of disease or edema on MRI or CT
scan allowed

- At least 6 weeks since prior definitive therapy (surgery or radiotherapy)

- No untreated or edematous metastatic brain lesions or leptomeningeal disease

- No ascites or pleural effusions

PATIENT CHARACTERISTICS:

Age:

- Over 18

Performance status:

- ECOG 0-1

Life expectancy:

- More than 3 months

Hematopoietic:

- WBC at least 3,000/mm3

- Platelet count at least 100,000/mm3

- Absolute granulocyte count at least 3,000/mm3

- Hemoglobin at least 10 g/dL

Hepatic:

- Direct bilirubin no greater than 1.5 mg/dL

- Transaminases no greater than 2 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 2 times ULN

- No severe coagulation disorder with PT/PTT greater than 2 times normal (without
anticoagulation medications)

- No hepatic insufficiency

- No alcoholic cirrhosis

Renal:

- Creatinine no greater than 2.0 mg/dL OR

- Creatinine clearance at least 60 mL/min

- No renal insufficiency

Cardiovascular:

- No congestive heart failure

- No serious cardiac arrhythmias

- No evidence of recent prior myocardial infarction on EKG

- No clinical coronary artery disease

Pulmonary:

- No chronic obstructive pulmonary disease

Immunologic:

- No prior eczema

- HIV negative

- No immunocompromising conditions, (e.g., active autoimmune disease, leukemia,
lymphoma, skin diseases, or open wounds)

- No clinical or laboratory evidence of an underlying immunosuppressive disorder

- No active or chronic infections

- No significant allergy or hypersensitivity to eggs

Other:

- No active seizure disorders

- No other malignancy within the past 2 years except stage I cervical cancer or basal
cell skin cancer, provided the tumor has been successfully treated and patient is
currently disease free

- No evidence of bone marrow toxicity

- No other concurrent medical illness that would preclude study

- No other contraindications to vaccinia virus administration

- No encephalitis

- Must be able to avoid close contact with children under 3 years of age; pregnant
women; individuals with prior or active eczema or other open skin conditions; or
immunosuppressed individuals for 7-10 days after each vaccination

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Prior vaccinia immunization required (e.g., smallpox vaccination)

- More than 8 weeks since prior immunotherapy and recovered

- No prior therapy with live vaccinia virus vector

Chemotherapy:

- More than 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

- At least 4 weeks since prior systemic corticosteroids

- No concurrent systemic corticosteroids

- No concurrent steroids

Radiotherapy:

- See Disease Characteristics

- More than 2 weeks since prior radiotherapy and recovered

Surgery:

- See Disease Characteristics

- More than 4 weeks since prior surgery for primary tumor or metastatic lesions and
recovered

Other:

- No concurrent immunosuppressive drugs

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Howard L. Kaufman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068831

NCT ID:

NCT00022568

Start Date:

August 2001

Completion Date:

Related Keywords:

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

Name

Location

Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032