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

NCT ID: NCT01247623

Last Updated: 2014-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2012-09-30

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.

Conditions

Malignant Melanoma

Interventions

GV1001

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Locations

Oslo University Hospital

Oslo, Postbox 4953, Norway

Countries

Norway

Other Identifiers

P03700

Identifier Type: -

Identifier Source: org_study_id