Influence of Chemotherapy on Gamma-delta T Cells in Patients With Epithelial Ovarian Cancer (IClyCO)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01606358
First received: May 23, 2012
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

In patients with an ovarian cancer, the treatment is currently based on surgery and chemotherapy.

The impact of chemotherapy on the expansion and functional abilities of Vgamma9Vdelta2 T cells has never been evaluated.

The long term goal is to give a rational to combine conventional treatment of ovarian cancer with immunotherapy based on Vgamma9Vdelta2 T cells.


Condition Intervention
Ovarian Cancer
Drug: Carboplatin and / or taxol chemotherapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: IClyCO Influence of Chemotherapy (Carboplatin and Taxol) on the ex Vivo Expansion and Functional Capacity of Gamma-delta T Cells in Patients With Epithelial Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Biospecimen Retention:   Samples Without DNA

The VGAMMA9VDELTA2 T cells will be isolated from peripheral blood mononuclear cells of patients with ovarian cancer.


Enrollment: 0
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ovarian Cancer Drug: Carboplatin and / or taxol chemotherapy
Patient with proven epithelial ovarian cancer and receiving carboplatin and / or taxol chemotherapy (usual care).

Detailed Description:

Ovarian cancer is associated with a high mortality rate. Treatment of ovarian cancer is currently based on surgery and chemotherapy.

The first surgery is a radical surgical procedure aiming to achieve no residual disease. Patients who could not benefit from the first surgery may be offered neoadjuvant chemotherapy with a new surgical procedure after 3 or 6 chemotherapy cycles. Chemotherapy is currently based on Taxol and Carboplatin. Immunotherapy based on Vgamma9Vdelta2 T cells could provide a promising therapeutic strategy, however, the impact of chemotherapy on the expansion and functional abilities of Vgamma9Vdelta2 T cells has never been evaluated.

We want to study the effect of chemotherapy of ovarian cancer on Vgamma9Vdelta2 T cells rates in the peripheral blood of patients with ovarian cancer.

Functional abilities of the Vgamma9Vdelta2 T cells will be studied: expansion after chemotherapy and their cytotoxic abilities in an autologous context before or after chemotherapy.

The long term goal is to give a rational to combine conventional treatment of ovarian cancer with non-conventional treatment such as immunotherapy based on Vgamma9Vdelta2 T cells.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient with proven epithelial ovarian cancer and receiving carboplatin and / or taxol chemotherapy.

Criteria

Inclusion Criteria:

  • Patients with proven epithelial ovarian cancer
  • Patients receiving carboplatin and / or taxol chemotherapy.

Exclusion Criteria:

  • Minor patient
  • Protected adult
  • Lack of invasion to the final histological checking
  • Absence of chemotherapy in the therapeutic plan of treatment
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01606358

Locations
France
CHU de RENNES
Rennes, France, 35000
Sponsors and Collaborators
Rennes University Hospital
Investigators
Study Chair: Bruno Laviolle, MD PhD Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01606358     History of Changes
Other Study ID Numbers: 2011-A00214-37
Study First Received: May 23, 2012
Last Updated: August 8, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Rennes University Hospital:
Ovarian Cancer
Patient with ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014