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Trial of Autologous, Hapten-Modified Vaccine in Patients With Stage III or IV Melanoma

NCT ID: NCT00257465

Last Updated: 2015-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-06-30

Brief Summary

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The purpose of this study is to determine whether a vaccine composed of patients' own melanoma cells treated with the chemical, dinitrophenyl (DNP)(called a hapten), is safe and stimulates an immune response to patients' own cancer cells.

Detailed Description

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Patients with stage III or IV melanoma need to have at least one tumor mass of at least 2.5 cm (about 1 inch) diameter than can be removed for vaccine production. If the vaccine is successfully made and if the patient is eligible, the patient will be assigned to receive one of 4 doses of the vaccine, include one group that will receive a zero dose. All patients will receive injections of their vaccine as part of immune system testing and will receive low dose cyclophosphamide and BCG. Eight injections of the vaccine will be administered as an injection into the skin of the arm over a 6 month period. Before and after vaccine administration, patients will be tested for immunity to their own melanoma cells by DTH testing, which is similar to a tuberculosis test. All side effects caused by the vaccine will be recorded.

Conditions

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Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

'Autologous, DNP-modified vaccine (M-Vax)'

Group Type EXPERIMENTAL

Autologous, DNP-modified vaccine (M-Vax)

Intervention Type BIOLOGICAL

5.0, 2.5, 0.5, or 0 cells

Autologous, DNP-Modified Melanoma Vaccine

Intervention Type BIOLOGICAL

5 million cells

B

Autologous, DNP-Modified Vaccine (MVax)

Group Type EXPERIMENTAL

Autologous, DNP-modified vaccine (M-Vax)

Intervention Type BIOLOGICAL

5.0, 2.5, 0.5, or 0 cells

Autologous, DNP-Modified Vaccine

Intervention Type BIOLOGICAL

2.5 million cells

C

Autologous, DNP-Modified Vaccine (MVax)

Group Type EXPERIMENTAL

Autologous, DNP-modified vaccine (M-Vax)

Intervention Type BIOLOGICAL

5.0, 2.5, 0.5, or 0 cells

Autologous, DNP-Modified Vaccine

Intervention Type BIOLOGICAL

0.5 million cells

D

0 cells

Group Type PLACEBO_COMPARATOR

Autologous, DNP-Modified Vaccine

Intervention Type BIOLOGICAL

0 cells

Interventions

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Autologous, DNP-modified vaccine (M-Vax)

5.0, 2.5, 0.5, or 0 cells

Intervention Type BIOLOGICAL

Autologous, DNP-Modified Melanoma Vaccine

5 million cells

Intervention Type BIOLOGICAL

Autologous, DNP-Modified Vaccine

2.5 million cells

Intervention Type BIOLOGICAL

Autologous, DNP-Modified Vaccine

0.5 million cells

Intervention Type BIOLOGICAL

Autologous, DNP-Modified Vaccine

0 cells

Intervention Type BIOLOGICAL

Other Intervention Names

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MVax MVax MVax MVax

Eligibility Criteria

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Inclusion Criteria

* stage III or IV melanoma at least one tumor mass of at least 2.5 cm diameter that can be excised to make vaccine good performance status

Exclusion Criteria

* brain metastases need for steroids or other immunosuppressive drugs positive PPD tests positive test for HIV, hepatitis B (antigen), or hepatitis C other serious medical illnesses
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AVAX Technologies

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Berd, MD

Role: PRINCIPAL_INVESTIGATOR

AVAX Technologies

Locations

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University of Arizona Cancer Center

Tucson, Arizona, United States

Site Status

Pacific Oncology and Hematology Associates

San Diego, California, United States

Site Status

University of Illinois School of Medicine

Chicago, Illinois, United States

Site Status

University of Louisville

Louisville, Kentucky, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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Berd D, Sato T, Maguire HC Jr, Kairys J, Mastrangelo MJ. Immunopharmacologic analysis of an autologous, hapten-modified human melanoma vaccine. J Clin Oncol. 2004 Feb 1;22(3):403-15. doi: 10.1200/JCO.2004.06.043. Epub 2003 Dec 22.

Reference Type BACKGROUND
PMID: 14691123 (View on PubMed)

Other Identifiers

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A/100/0401

Identifier Type: -

Identifier Source: org_study_id