Status:
COMPLETED
Trial With Telomerase Peptide Vaccine In Combination With Temozolomide in Patients With Advanced Malignant Melanoma
Lead Sponsor:
Oslo University Hospital
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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 immunisati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
September 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01247623
Start Date
January 1 2005
End Date
September 1 2012
Last Update
November 5 2014
Active Locations (1)
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1
Oslo University Hospital
Oslo, Postbox 4953, Norway, 0424