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

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.

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Key information

Conditions

Malignant Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Oslo University Hospital

Oslo, Postbox 4953, 0424, Norway

Who can participate

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

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.

Treatment and study plan

GV1001

Biological

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Important dates

Study start: 2005
Primary completion: 2011
Study completion: 2012
First posted: Nov 24, 2010
Registry last updated: Nov 5, 2014

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.

Published trials that share one or more normalized conditions with this study.

Completed