Influence of Chemotherapy on Gamma-delta T Cells in Patients With Epithelial Ovarian Cancer (IClyCO)
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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 |
The VGAMMA9VDELTA2 T cells will be isolated from peripheral blood mononuclear cells of patients with ovarian cancer.
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2012 |
| Primary Completion Date: | May 2012 (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 |
Patient with proven epithelial ovarian cancer and receiving carboplatin and / or taxol chemotherapy.
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| Contact: Vincent Lavoué, MD | 2 99 26 59 72 ext + 33 | vincent.lavoue@chu-rennes.fr |
| France | |
| CHU de RENNES | Recruiting |
| Rennes, France, 35000 | |
| Contact: Vincent Lavoué, MD 2 99 26 59 72 ext + 33 vincent.lavoue@chu-rennes.fr | |
| Sub-Investigator: Jean Levêque, MD PhD | |
| Sub-Investigator: Fabrice Foucher, MD | |
| Sub-Investigator: Estelle Bauville, MD | |
| Sub-Investigator: Sébastien Henno, MD | |
| Sub-Investigator: Françoise Bouet, MD | |
| Sub-Investigator: Véronique Catros, MD | |
| Sub-Investigator: Florian Cabillic, MD | |
| Study Chair: | Bruno Laviolle, MD PhD | CHU de Rennes |
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: | December 3, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
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 Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
Neoplasms by Histologic Type Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 19, 2013