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NCT Number: NCT02515877

Modulation of the Expression of Papillomavirus (HPV) Oncoproteins to Major the Radiosensitivity: Trial Combining an Antiviral Agent VISTIDE and Radiochemotherapy in Cervical Cancers

The treatment of cervical tumors depends on the stage of the disease. In advanced forms (nodal and / or local extension to the vagina and / or parameters) , radiotherapy associated with curietherapy , plays a major role. Until recently this association was the standard treatment for advanced stage uterine cancer. With this combination, rates of local failures (evolutionary prosecution and local recurrences) were 20 to 50% in stages IIb and 50-75 % for stage III. More than 50% for patients with a cervical cancer locally advanced (FIGO stages II / IV) . The standard treatment, external radiotherapy followed by curietherapy allows expect survival rates at 5 years for approximately 30-45 %. For ten years, numerous studies have evaluated the addition of concurrent chemotherapy to radiotherapy in cancer of the cervix. More than 19 randomized trials have been published. A meta-analysis of these trials was undertaken to assess the role of radiochemotherapy in cancers of the cervix. The first meta-analysis published by the Cochrane Collaborative Group, taking into account 4580 patient, shows an improvement in survival, both in terms of progression free survival and overall survival for patients treated with radio chemotherapy respectively 16% and 12 % (p < 0.0001). The rate of metastasis is also decreased (p < 0.0001). Survival rates were significantly better when platinum salt was used ( p < 0.0001 ) . However, no clinical benefit of chemoradiotherapy has been demonstrated for tumors stages [1, 2] locally advanced, possibly due to small number of patients. The investigators have previously shown that antiviral agents used in preclinical models, Cidofovir® causes the selective radiosensitization of cells infected by the papillomavirus (HPV). This trial proposes to study a new concept to increase radiochemotherapy efficiency: the modulation of the expression of viral oncoproteins HPV virus by an antiviral agent.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val de Marne, 94805, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with cervix cancer : Squamous cell carcinoma or adenocarcinoma of stage IB2> 4 cm, II, III or IVA (International Federation of Gynecology Obstetrics, regardless of pelvic lymph node status (optional surgical exploration) without paraaortic metastasis.
  • Detection of the virus genome of HPV positive on the primary tumor.
  • General state ECOG performance status 0-1.
  • 18 </ = age </ = 70 years.
  • PN> 2000 / mm3
  • hemoglobin> 9 g/l after transfusion if necessary .
  • platelets > 100 000 / mm3
  • Serum creatinine <1.5 upper limit of normal.
  • Liver function tests (SGOT, SGPT, alkaline phosphatase and bilirubin) <1.5 upper limit of normal.
  • Life expectancy> 3 months.
  • Systematic Beta HCG Dosage for premenopausal women.
  • Informed consent signed after informing the patient.
  • Proteinuria <2g / L (200mg / dL) and creatinine clearance of> / = 55 ml / min.

Exclusion criteria

  • Other histological types of cervix tumor than those mentioned in the inclusion criteria.
  • Search of viral sequences on the negative HPV tumor diagnosis.
  • History of cancer other than basal cell carcinoma.
  • Pre-treatment with radiotherapy or chemotherapy.
  • Ongoing pregnancy.
  • History or active psychiatric illness.
  • Nephropathy whatever the grade.
  • Infection scalable.
  • Active infection or other serious underlying pathology may prevent the patient receiving the treatment (in particular hepatic or cardiac).
  • Inclusion in another clinical trial protocol with an experimental molecule (during the study or within one month before inclusion).
  • Inability to submit to medical monitoring study for geographical, social or psychological.

Treatment and study plan

External radiotherapy + curietherapy

Radiation

External radiotherapy: 45 Gy in 5 weeks Curietherapy: 15Gy

Vistide

Drug

VISTIDE® (mg/kg) Level 1: 1mg/kg Level 2: 2,5 mg/kg Level 3: 5 mg/kg Level 4: 6,5 mg/kg

carboplatin

Drug

AUC= 2,5 (Calvert formula)

Primary outcomes

  1. Dose limiting toxicity

    Time frame: Assessed every week after inclusion up to 10 weeks

Secondary outcomes

  1. Efficacy Using RECIST criteria

    Time frame: Assessed 14 weeks after inclusion

    Using RECIST criteria

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Collaborators

  • National Cancer Institute, France

Registry information

Official study title

Modulation of the Expression of Papillomavirus (HPV) Oncoproteins to Major the Radiosensitivity: Phase I Trial Combining an Antiviral Agent VISTIDE and Radiochemotherapy in Cervical Cancers

Acronym: HPV-RX

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Aug 5, 2015
Registry last updated
Jun 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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