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A Phase II, Open-Label Trial Evaluating GV1001 in Advanced Hepatocellular Carcinoma.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00444782
First Posted: March 8, 2007
Last Update Posted: December 18, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pharmexa A/S
March 7, 2007
March 8, 2007
December 18, 2008
November 2006
April 2008   (Final data collection date for primary outcome measure)
Response rate (Partial and Complete Response) according to modified RECIST.
Same as current
Complete list of historical versions of study NCT00444782 on ClinicalTrials.gov Archive Site
  • Time to Progression (TTP)
  • Time to Symptomatic Progression (TTSP)
  • Progression Free Survival (PFS)
  • Immune Response
Same as current
Not Provided
Not Provided
 
A Phase II, Open-Label Trial Evaluating GV1001 in Advanced Hepatocellular Carcinoma.
"Heptovax" - A Phase II, Open-Label Trial Evaluating the Safety and Efficacy of GV1001 in Advanced Hepatocellular Carcinoma.
The purpose of this study is to investigate the efficacy of GV1001 in locally advanced or metastatic HCC. Also the safety of GV1001 and immunogenicity will be evaluated.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Hepatocellular
Biological: GV1001
Not Provided
Greten TF, Forner A, Korangy F, N'Kontchou G, Barget N, Ayuso C, Ormandy LA, Manns MP, Beaugrand M, Bruix J. A phase II open label trial evaluating safety and efficacy of a telomerase peptide vaccination in patients with advanced hepatocellular carcinoma. BMC Cancer. 2010 May 17;10:209. doi: 10.1186/1471-2407-10-209.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
April 2008
April 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hepatocellular carcinoma diagnosis fulfilling one of the following criteria (as per the American Association for the Study of Liver Diseases [AASLD] guidelines, see Appendix 5):

    1. Nodule in a cirrhotic or non-cirrhotic liver with a biopsy showing HCC;
    2. Nodule in cirrhotic liver where no biopsy is performed:

      • Nodules between 1-2 cm in a cirrhotic liver with a typical coincidal vascular pattern of HCC (i.e. hypervascular with washout in the portal/venous phase) in two dynamic studies: either CT scan, contrast ultrasound or MRI with contrast.
      • Nodule larger than 2 cm in a cirrhotic liver with a typical vascular pattern of HCC on a dynamic imaging technique.

Please note: HCC in a non-cirrhotic liver can only be diagnosed with a biopsy showing HCC.

  • Measurable disease according to modified RECIST (see Appendix 7).
  • At least one treatment-naïve target lesion (treatment-naïve being defined as not having been treated with local therapy, such as surgery, radiation therapy, hepatic arterial embolisation, chemoembolisation, radio-frequency ablation or cryo-ablation).
  • Barcelona Clinic Liver Cancer (BCLC) stage A, B or C (see Appendix 6) (Stage D is excluded).
  • Child-Pugh stage A (see Appendix 8).
  • Male or female aged 18 years or older.
  • Adequate haematological parameters, as demonstrated by:

    • Haemoglobin greater than or equal to 9.0 g/dL (SI units: 5.6 mmol/L);
    • WBC greater than or equal to 3.0 x 109/L;
    • Platelets greater than or equal to 75 x 109/L.
  • ALT and AST ≤ 5 times the upper limit of normal.
  • Bilirubin < 2 mg/dL.
  • Serum creatinine smaller than or equal to 1.5 mg/dL (SI units: 132 µmol/L).
  • Performance status ECOG 0 or 1.
  • Minimum life expectancy of 3 months at screening.
  • Written informed consent given prior to any study specific procedures.

Exclusion Criteria:

  • HCC amenable to curative treatment or transplantation.
  • History of other malignancies in the last 5 years (10 years in the case of breast cancer), except for adequately treated non-melanoma skin cancers (Basal Cell Carcinoma, Squamous Cell Carcinoma) and carcinoma in situ of the cervix.
  • Known history of or co-existing autoimmune disease.
  • Known Central Nervous System (CNS) metastases.
  • Known history of human immunodeficiency virus (HIV).
  • Any medical condition that, in the opinion of the Investigator, may compromise the compliance of the patient to receive study treatment and follow study procedures.
  • Treatment with any other IMP within 4 weeks prior to cyclophosphamide administration at Day -3.
  • Known sensitivity to any components of cyclophosphamide, GV1001 or GM-CSF.
  • Concomitant treatment with the following within 4 weeks of pre-treatment with cyclophosphamide:

    • Anti-tumour treatment (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, cytokines, interferons, protease inhibitors, and gene therapy) and vaccines.
    • Chronic corticosteroids (inhaled and topical steroids are permitted including low dose steroids at non-immunosuppressive doses e.g. 15 mg prednisolone daily for up to 7 days).
    • Herbal medicine either containing hypericum perforacum (e.g., St Johns Wort) or claiming to have anti-tumour effects (e.g., Iscador).
  • Pregnancy or lactation.
  • Women of childbearing potential not using reliable and adequate contraceptive methods, defined as the use of oral, implanted, injectable, mechanical or barrier products for the prevention of pregnancy; or women who are practising abstinence; or where the partner is sterile, for example a vasectomy.
  • Unable for any other reason to comply with the protocol (treatment or assessments).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Spain
 
 
NCT00444782
PX115.1.1-201
Not Provided
Not Provided
Not Provided
Lotte Rosendahl, Pharmexa
Pharmexa A/S
Not Provided
Study Chair: Lotte Rosendahl, Pharmacist (CTM) Pharmexa A/S
Pharmexa A/S
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP