Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy in Treating Patients With Metastatic Melanoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	Over 18	NCI	CPMC-IRB-14387 AECM-01-003, NCI-3353, NCT00022568, 3353

Objectives

1. Determine the maximum tolerated dose of recombinant vaccinia-TRICOM vaccine in patients with metastatic melanoma.
2. Determine the clinical toxic effects of this vaccine in these patients.
3. Determine the safety of this vaccine in these patients.
4. Determine the clinical response of these patients to this vaccine.
5. Determine evidence of host anti-melanoma immune reactivity in these patients after treatment with this vaccine.

Entry 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

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Howard Kaufman, MD, Protocol chair(Contact information may not be current)		Ph: 212-342-6042 Email: hlk2003@columbia.edu

Registry Information
Official Title		A Phase I Trial of Intra Lesional rV-Tricom Vaccine in the Treatment of Malignant Melanoma
Trial Start Date		2001-08-27
Registered in ClinicalTrials.gov		NCT00022568
Date Submitted to PDQ		2001-06-27
Information Last Verified		2003-12-08
NCI Grant/Contract Number		P30-CA13696