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MelanomaPhase 1/2NCT00257465

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

A Phase 1/2 study testing Autologous, DNP-modified vaccine (M-Vax), Autologous, DNP-Modified Melanoma Vaccine and Autologous, DNP-Modified Vaccine in people with Melanoma, run by AVAX Technologies at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
Autologous, DNP-modified vaccine (M-Vax), Autologous, DNP-Modified Melanoma Vaccine and Autologous, DNP-Modified Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
82 participants
Where
7 sitesUnited States
Study dates
Jun 2005to Jun 2008
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • University of Illinois School of Medicine

    Chicago, Illinois, 60612

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Louisville

    Louisville, Kentucky

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Pacific Oncology and Hematology Associates

    San Diego, California, 92024

  • University of Arizona Cancer Center

    Tucson, Arizona

Other trials in United States

About this study

Official title: M-Vax: A Feasibility and Bio-Equivalence Study Using a DNP-Modified Autologous Melanoma Tumor Cell Vaccine as Therapy in Patients With Stage III or IV Melanoma

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.

Read the detailed description

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
Melanoma
Being tested
Autologous, DNP-modified vaccine (M-Vax), Autologous, DNP-Modified Melanoma Vaccine, Autologous, DNP-Modified Vaccine
Keywords
melanoma, metastatic, vaccine, immunotherapy, autologous
Medical subject headings
Melanoma, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous, DNP-modified vaccine (M-Vax)Biological

    5.0, 2.5, 0.5, or 0 cells

  • Autologous, DNP-Modified Melanoma VaccineBiological

    Also called MVax

    5 million cells

  • Autologous, DNP-Modified VaccineBiological

    Also called MVax

    2.5 million cells

  • Autologous, DNP-Modified VaccineBiological

    Also called MVax

    0.5 million cells

  • Autologous, DNP-Modified VaccineBiological

    Also called MVax

    0 cells

Study groups in NCT00257465
Study groupRoleWhat they receive
AExperimental'Autologous, DNP-modified vaccine (M-Vax)'
Receives: Biological: Autologous, DNP-modified vaccine (M-Vax); Biological: Autologous, DNP-Modified Melanoma Vaccine
BExperimentalAutologous, DNP-Modified Vaccine (MVax)
Receives: Biological: Autologous, DNP-modified vaccine (M-Vax); Biological: Autologous, DNP-Modified Vaccine
CExperimentalAutologous, DNP-Modified Vaccine (MVax)
Receives: Biological: Autologous, DNP-modified vaccine (M-Vax); Biological: Autologous, DNP-Modified Vaccine
DPlacebo comparator0 cells
Receives: Biological: Autologous, DNP-Modified Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immune response to patients' own melanoma cells

    Measured: 2 months

Secondary outcomes (1)

  1. Safety

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2005 (estimated)
  2. Study startJun 2005
  3. Primary completionJun 2008
  4. Study completionJun 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00257465
Sponsor's protocol ID
A/100/0401
Status last verified
Dec 2015
First submitted
22 Nov 2005
Last updated
3 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 14691123

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Autologous, DNP-modified vaccine (M-Vax), Autologous, DNP-Modified Melanoma Vaccine and Autologous, DNP-Modified Vaccine in people with Melanoma, run by AVAX Technologies at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immune response to patients' own melanoma cells (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00257465, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.

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