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


Phase 1/Phase 2
18 Years
75 Years
Not Enrolling
Both
Malignant Melanoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

N/A

Authority:

Norway:Institutional Review Board

Study ID:

P03700

NCT ID:

NCT01247623

Start Date:

Completion Date:

Related Keywords:

  • Malignant Melanoma
  • Non-resectable, advanced malignant melanoma.
  • Melanoma

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