Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma

February 8, 2013 updated by: National Cancer Institute (NCI)

A Phase I Trial of Intra Lesional RV-B7.1 Vaccine in the Treatment of Malignant Melanoma

Phase I trial to study the effectiveness of vaccine therapy in treating patients who have unresectable metastatic melanoma. Vaccines may make the body build an immune response to kill tumor cells.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

I. Determine the maximum tolerated dose of the rV-B7.1 vaccine that elicits a host immune response and is associated with acceptable toxicity in patients with malignant metastatic melanoma.

II. Determine all clinical toxicities associated with this regimen in this patient population.

III. Determine the safety of this regimen in this patient population. IV. Assess evidence of host antimelanoma immune reactivity following this regimen.

V. Determine the effect of this regimen on T-cell immunity. VI. Assess the clinical response in this patient population receiving this regimen.

VII. Evaluate quality of life of these patients during this regimen.

OUTLINE: This is a dose escalation study.

Patients receive rV-B7.1 intralesionally every 4 weeks for 8 weeks (weeks 0, 4, and 8). Treatment continues every 12 weeks in the absence of unacceptable toxicity or disease progression for up to 2 courses. Cohorts of 6-8 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose limiting toxicities.

Quality of life is assessed before treatment, every 4 weeks, and at end of treatment. Patients are followed every 3 months.

Study Type

Interventional

Enrollment (Actual)

12

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
      • Bronx, New York, United States, 10461
        • Albert Einstein Comprehensive Cancer Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically proven metastatic, unresectable melanoma Dermal, subcutaneous, or lymph node metastases
  • Accessible for injection
  • Lesions must measure at least 1 cm
  • Patients with no prior treatment allowed

  • Patients must have one of the following as proof of prior vaccinia immunization:

    • Physician certification
    • Recollection and appropriate vaccination scar site
    • No encephalitis, untreated cerebral metastases, other structural brain lesions, or leptomeningeal disease
    • No ascites or pleural effusions
    • No leukemia or lymphoma

PATIENT CHARACTERISTICS:

  • Age: Over 18
  • Performance status: ECOG 0-1 Karnofsky 80-100%
  • Life expectancy: Greater than 3 months
  • WBC greater than 4,000/mm3
  • Platelet count greater than 100,000/mm3
  • Hemoglobin greater than 10g/dL
  • Bilirubin less than 1.5 mg/dL
  • Transaminases no greater than 2 times upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2 times ULN
  • PT/PTT no greater than 2 fold elevation in patients not receiving anticoagulation medications
  • No alcoholic cirrhosis
  • Creatinine less than 2.0 mg/dL OR creatine clearance greater than 60 mL/min
  • No congestive heart failure
  • No serious cardiac arrhythmias
  • No recent prior myocardial infarction
  • No clinical coronary artery disease
  • No chronic obstructive pulmonary disease
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No seizure disorders
  • No underlying immunosuppressive disorder
  • No autoimmune disease HIV negative
  • No skin diseases
  • No open wounds
  • No eczema or other contraindications to vaccinia virus administration
  • Patients must be able to avoid high risk individuals (e.g., immunosuppressed patients, children under 3 years, pregnant women, patients with active or a history of eczema, or patients with other skin conditions) for 7-10 days following treatment
  • No significant allergy or hypersensitivity to eggs
  • No active or chronic infections
  • No concurrent medical illness
  • No other significant medical disease which would increase risk to patient
  • No other prior malignancy within the past 5 years except stage I carcinoma of the cervix or basal cell carcinoma

PRIOR CONCURRENT THERAPY:

  • At least 8 weeks since prior immunotherapy and recovered
  • No prior live pox virus vector
  • No more than 2 prior chemotherapy regimens
  • At least 4 weeks since prior chemotherapy and recovered
  • At least 4 weeks since prior systemic corticosteroids
  • No systemic corticosteroids for concurrent illness
  • No concurrent immunosuppressive steroids
  • At least 2 weeks since prior radiotherapy and recovered (no bone marrow toxicity)
  • At least 6 months since prior radiotherapy for brain metastases and recovered
  • At least 4 weeks since prior surgery for management of the primary or metastatic lesions and recovered with remaining measurable disease
  • At least 6 months since prior surgery for brain metastases and recovered
  • 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
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Patients receive rV-B7.1 intralesionally every 4 weeks for 8 weeks (weeks 0, 4, and 8). Treatment continues every 12 weeks in the absence of unacceptable toxicity or disease progression for up to 2 courses. Cohorts of 6-8 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose limiting toxicities.
Biological: recombinant vaccinia-B7.1 vaccine

Collaborators and Investigators

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

Sponsor

National Cancer Institute (NCI)

Investigators

  • Study Chair: Howard L. Kaufman, MD, Albert Einstein College Of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 1999

Primary Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

December 10, 1999

First Submitted That Met QC Criteria

February 19, 2004

First Posted (Estimate)

February 20, 2004

Study Record Updates

Last Update Posted (Estimate)

February 11, 2013

Last Update Submitted That Met QC Criteria

February 8, 2013

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067380
  • AECM-99-101
  • NCI-T99-0006

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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