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

This study has been completed.
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01247623
First received: November 23, 2010
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

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:

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247623

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

No publications provided

ClinicalTrials.gov Identifier: NCT01247623     History of Changes
Other Study ID Numbers: P03700
Study First Received: November 23, 2010
Last Updated: July 21, 2011
Health Authority: Norway:Institutional Review Board
Norway: Norwegian Medicines Agency

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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014