NCT01331915

Brief Summary

In this phase I study, the investigators want to vaccine with THERAVAC® (an inactivated toxin coupled to melanoma antigen) some patients with advanced metastatic melanoma disease. The primary objective is to analyze the safety of the inreasing doses of vaccine. The secondary objective is to document whether this vaccine can induce tumor regression in immunized patients.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 8, 2011

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Last Updated

October 10, 2012

Status Verified

October 1, 2012

Enrollment Period

3.1 years

First QC Date

January 20, 2011

Last Update Submit

October 8, 2012

Conditions

Melanoma

Keywords

Metastatic MelanomaSafetyTheravac vaccineHLA-A2 typingTyrosinase.A2 gene expression

Outcome Measures

Primary Outcomes (2)

  • To analyze the safety and toxicity of increasing doses of Theravac® in patients with advanced metastatic melanoma

    The toxicity will be assess after the treatment (3 months) for the first three patients of each group.

    the first 3 months of treatment

  • To determine whether these immunizations result in a detectable immune response

    PBMC will be obtained from the buffy-coat of 500 ml of venous blood or from 100 ml of venous blood collected before and after immunization.

    Up to 24 weeks

Secondary Outcomes (1)

  • To document whether this vaccine can induce tumor regression in immunized patients.

    at week 12

Study Arms (1)

Theravac

EXPERIMENTAL

Theravac® is a recombinant adenylate cyclase toxin from Bordetella pertussis that has been detoxified by mutation of its catalytic domain, and which has been coupled to the Tyrosinase.A2 epitope YMDGTMSQV.

Biological: Theravac

Interventions

TheravacBIOLOGICAL

Three groups with three doses (50 - 150 - 250 mcg), four times every three weeks. Injection: intradermally and subcutaneously.

Theravac

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven cutaneous, uveal or mucosal melanoma.
  • Melanoma must be metastatic. The origin of the primary could be cutaneous, uveal or mucosal and any metastatic stage is accepted, except if brain or leptomeningeal localizations are present, or if plasma LDH are elevated more than 1.5 normal upper values (see also below).
  • HLA-A2 positive.
  • The melanoma must express the tyrosinase gene (positive RT-PCR on a frozen pre-immune tumor sample) (see Appendix B).
  • At least one measurable or non-measurable tumor lesion (see Section 8.1).
  • Expected survival of at least 3 months.
  • Karnofsky performance scale ≥70 or WHO performance status of 0 or 1 (see Appendix C).
  • Vital laboratory parameters should be within normal range, except for the following laboratory parameters, which must be within the ranges specified:
  • Lab Parameter Range Hemoglobin ≥ 10 g/dl or ≥ 6,25 mmol/l Granulocytes ≥ 1,500/µl Lymphocytes ≥ 700/µl Platelets ≥ 100,000/µl Serum creatinin ≤ 2.0 mg/dl or ≤ 177 μmol/l Serum bilirubin ≤ 2.0 mg/dl or ≤ 34.2 μmol/l ASAT and ALAT ≤ 2 x the normal upper limits LDH ≤ 1.5 x the normal upper limit.
  • Viral serology:
  • HIV (human immunodeficiency virus): negative antibodies.
  • HBV (hepatitis B virus): negative antigens; antibodies may be positive.
  • HCV (hepatitis C virus): negative antibodies.
  • Age ≥ 18 years
  • Able and willing to give valid written informed consent

You may not qualify if:

  • Previous treatment with more than one regimen of systemic chemotherapy, combined or not with non-specific immunotherapy such as interferon alpha or interleukins. Chemoimmunotherapy or radiotherapy must be stopped within the preceding 4 weeks (6 weeks for nitrosoureas and mitomycin C).
  • Previous treatment with a vaccine known or likely to contain the Tyrosinase.A2 epitope YMDGTMSQV.
  • Clinically significant heart disease (NYHA Class III or IV) i.e. NYHA class 3 congestive heart failure; myocardial infarction within the past six months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias.
  • Other serious acute or chronic illnesses, e.g. active infections requiring antibiotics, bleeding disorders, or other conditions requiring concurrent medications not allowed during this study.
  • Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ.
  • Allergy to kanamycin (used in the preparation of the recombinant protein) or to any other aminoglycoside antibiotic.
  • Lack of availability for immunological and clinical follow-up assessments.
  • Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
  • Pregnancy or breastfeeding.
  • Women of childbearing potential: Refusal or inability to use effective means of contraception.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc, Centre du Cancer

Brussels, Brussels Capital, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jean-François Baurain, MD, PhD

    Cliniques universitaires Saint-Luc, Centre du Cancer

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-François Baurain, MD, PhD

CONTACT

0032 2 764 54 71jean-francois.baurain@uclouvain.be

Aline Gillain, MSc

CONTACT

0032 2 764 54 85aline.gillain@uclouvain.be

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2011

First Posted

April 8, 2011

Study Start

September 1, 2010

Primary Completion

October 1, 2013

Last Updated

October 10, 2012

Record last verified: 2012-10

Locations

BE(1)