NCT00324623

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, may be used to prepare the body for other treatments, such as cellular adoptive immunotherapy. Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines may help the body build an effective immune response to kill tumor cells. Giving cyclophosphamide together with fludarabine followed by biological therapy may be an effective treatment for metastatic melanoma. PURPOSE: This phase I trial is studying the side effects of giving cyclophosphamide together with fludarabine followed by cellular adoptive immunotherapy, and vaccine therapy in treating patients with metastatic melanoma.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2006

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Last Updated

November 20, 2012

Status Verified

November 1, 2012

Enrollment Period

6.2 years

First QC Date

May 10, 2006

Last Update Submit

November 19, 2012

Conditions

Melanoma (Skin)

Keywords

stage IV melanomarecurrent melanoma

Outcome Measures

Primary Outcomes (3)

  • Phenotype, function, and T-cell receptor repertoire

    Anti-tumor immune response evaluated at each vaccine and until the last administered vaccine

  • Tumor response

    Tumor response evaluated 4 weeks after last vaccine

  • Toxicity

    Within 30 days after completion of the last vaccine

Study Arms (1)

Lymphodepletion, vaccine, IMP321 adjuvant

EXPERIMENTAL
Biological: Melan-A VLP vaccine, IMP321 adjuvantBiological: adoptive immunotherapyBiological: therapeutic autologous lymphocytesDrug: cyclophosphamideDrug: fludarabine phosphate

Interventions

Melan-A VLP vaccine, IMP321 adjuvantBIOLOGICAL
Lymphodepletion, vaccine, IMP321 adjuvant
adoptive immunotherapyBIOLOGICAL
Lymphodepletion, vaccine, IMP321 adjuvant
therapeutic autologous lymphocytesBIOLOGICAL
Lymphodepletion, vaccine, IMP321 adjuvant
cyclophosphamideDRUG
Lymphodepletion, vaccine, IMP321 adjuvant
fludarabine phosphateDRUG
Lymphodepletion, vaccine, IMP321 adjuvant

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of metastatic melanoma * Progressive disease after receiving prior Melan-A peptide vaccine on an immunotherapy protocol of the Ludwig Institute AND achieved a detectable immune response (increase of specific CD8\^+ TET\^+ Melan-A) * Tumor must express MART-1/Melan-A antigen * HLA-A2 positive * Not eligible for other protocols due to progressive disease OR maximum number of vaccine injections with stable disease has been attained PATIENT CHARACTERISTICS: * Performance status 0-2 * Whole blood counts normal * Pulmonary status normal * Transaminases \< 1.5 times upper limit of normal (ULN) * Gamma-glutamyl-transferase \< 1.5 times ULN * Bilirubin normal * Creatinine clearance \> 70 mL/min * No major uncontrolled heart disease * No arterial hypertension PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Prior chemotherapy, biologic therapy, radiotherapy, and/or surgery allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Related Publications (1)

  • Romano E, Michielin O, Voelter V, Laurent J, Bichat H, Stravodimou A, Romero P, Speiser DE, Triebel F, Leyvraz S, Harari A. MART-1 peptide vaccination plus IMP321 (LAG-3Ig fusion protein) in patients receiving autologous PBMCs after lymphodepletion: results of a Phase I trial. J Transl Med. 2014 Apr 12;12:97. doi: 10.1186/1479-5876-12-97.

    PMID: 24726012DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

Immunotherapy, AdoptiveCyclophosphamidefludarabine phosphate

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

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative TechniquesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Serge Leyvraz, MD

    Centre Hospitalier Universitaire Vaudois

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chef de Service

Study Record Dates

First Submitted

May 10, 2006

First Posted

May 11, 2006

Study Start

September 1, 2005

Primary Completion

November 1, 2011

Last Updated

November 20, 2012

Record last verified: 2012-11

Locations

CH(1)