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

Primary Purpose

Malignant Melanoma

Status
Completed
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
GV1001
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional trial for Malignant Melanoma focused on measuring Non-resectable, advanced malignant melanoma.

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All Sexes

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.

Sites / Locations

  • Oslo University Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 23, 2010
Last Updated
November 4, 2014
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01247623
Brief Title
Trial With Telomerase Peptide Vaccine In Combination With Temozolomide in Patients With Advanced Malignant Melanoma
Official Title
Trial With Telomerase Peptide Vaccine In Combination With Temozolomide in Patients With Advanced Malignant Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma
Keywords
Non-resectable, advanced malignant melanoma.

7. Study Design

Study Phase
Phase 1, Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
GV1001

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Eligibility 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.
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
State/Province
Postbox 4953
ZIP/Postal Code
0424
Country
Norway

12. IPD Sharing Statement

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

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