Vaccine Therapy in Treating Patients With Metastatic Melanoma

December 17, 2013 updated by: Herbert Irving Comprehensive Cancer Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herbert Irving Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Howard L. Kaufman, MD, Herbert Irving Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Study Registration Dates

First Submitted

August 10, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

December 18, 2013

Last Update Submitted That Met QC Criteria

December 17, 2013

Last Verified

December 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068831
  • CPMC-IRB-14387
  • AECM-01-003
  • NCI-3353

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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