ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01247623
Recruitment Status : Completed
First Posted : November 24, 2010
Last Update Posted : November 5, 2014
Sponsor:
Information provided by:
Oslo University Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Malignant Melanoma Biological: GV1001 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Official Title: Trial With Telomerase Peptide Vaccine In Combination With Temozolomide in Patients With Advanced Malignant Melanoma
Study Start Date : January 2005
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247623


Locations
Norway
Oslo University Hospital
Oslo, Postbox 4953, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital

ClinicalTrials.gov Identifier: NCT01247623     History of Changes
Other Study ID Numbers: P03700
First Posted: November 24, 2010    Key Record Dates
Last Update Posted: November 5, 2014
Last Verified: November 2014

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

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents