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

Malignant Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01247623
• Other study ID #: P03700
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 23, 2010
• Last updated: November 4, 2014
• Start date: January 2005
• Est. completion date: September 2012

Study information

• Verified date: November 2014
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:Institutional Review BoardNorway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2012
• Est. primary completion date: September 2011
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

Biological:
• GV1001

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo	Postbox 4953

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway,