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Trial With Telomerase Peptide Vaccine In Combination With Temozolomide in Patients With Advanced Malignant Melanoma

This study has been completed.
Information provided by:
Oslo University Hospital Identifier:
First received: November 23, 2010
Last updated: November 4, 2014
Last verified: November 2014

Primary objective: Determination of safety and tolerability of GV1001 administration combined with Temozolomide (based on blood samples and adverse events).

Feasibility of combining active immunisation with Temozolomide treatment. Determination of immunological response after administration of GV1001 and Temozolomide as measured by presence of DTH skin test reaction and specific T-cell responses.

Secondary: Evaluation of objective tumour response

The trial is an exploratory study which main objective is to estimate safety and feasibility of combining active immunisation with chemotherapy. However, the trial may also indicate the efficacy of the combination.

Condition Intervention Phase
Malignant Melanoma
Biological: GV1001
Phase 1
Phase 2

Study Type: Interventional
Official Title: Trial With Telomerase Peptide Vaccine In Combination With Temozolomide in Patients With Advanced Malignant Melanoma

Resource links provided by NLM:

Further study details as provided by Oslo University Hospital:

Study Start Date: January 2005
Study Completion Date: September 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Histologically confirmed diagnosis of malignant melanoma.
  • Previously untreated and non-resectable disease
  • Measurable or evaluable tumour.
  • Age ≥ 18 and ≤ 75 years.
  • Performance status ECOG-WHO 0, 1 and 2 (Appendix III)
  • Written informed consent (Appendix II)
  • Adequate bone marrow liver, heart and renal function:
  • WBC count >3.0 x 109/L and platelets count >100 x 109/L.
  • ASAT, ALAT <2 x upper normal laboratory value.
  • Serum creatinine <2 x upper normal laboratory value.

Exclusion Criteria:

  • Previous treatment with chemotherapy.
  • Clinical signs of brain metastases.
  • Severe cardiac insufficiency (NYHA III or IV) with uncontrolled and/or unstable cardiac or coronary artery disease.
  • Severe active infections such as HIV or hepatitis B or Hepatitis C.
  • Medication for severe intercurrent disease which might affect immunocompetence (e.g. immunosuppressants, systemic corticosteroids).
  • Pregnancy, breast-feeding or absence of adequate contraception for fertile patients.
  • Simultaneously participation in other clinical studies.
  • Any reason why, in the opinion of the investigator, the patient should not participate.
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Please refer to this study by its identifier: NCT01247623

Oslo University Hospital
Oslo, Postbox 4953, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
  More Information Identifier: NCT01247623     History of Changes
Other Study ID Numbers: P03700
Study First Received: November 23, 2010
Last Updated: November 4, 2014

Keywords provided by Oslo University Hospital:
Non-resectable, advanced malignant melanoma.

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on May 25, 2017