Vaccine Therapy in Treating Patients With Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00022568
Recruitment Status : Unknown
Verified December 2003 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 18, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: recombinant vaccinia-TRICOM vaccine Phase 1

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I Trial of Intra Lesional rV-Tricom Vaccine in the Treatment of Malignant Melanoma
Study Start Date : August 2001

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • Over 18

Performance status:

  • ECOG 0-1

Life expectancy:

  • More than 3 months


  • 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


  • 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


  • Creatinine no greater than 2.0 mg/dL OR
  • Creatinine clearance at least 60 mL/min
  • No renal insufficiency


  • No congestive heart failure
  • No serious cardiac arrhythmias
  • No evidence of recent prior myocardial infarction on EKG
  • No clinical coronary artery disease


  • No chronic obstructive pulmonary disease


  • 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


  • 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


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


  • 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


  • See Disease Characteristics
  • More than 2 weeks since prior radiotherapy and recovered


  • See Disease Characteristics
  • More than 4 weeks since prior surgery for primary tumor or metastatic lesions and recovered


  • No concurrent immunosuppressive drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00022568

United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Howard L. Kaufman, MD Herbert Irving Comprehensive Cancer Center Identifier: NCT00022568     History of Changes
Other Study ID Numbers: CDR0000068831
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: December 2003

Keywords provided by National Cancer Institute (NCI):
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Immunologic Factors
Physiological Effects of Drugs
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents