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

NCT01247623 | Completed Phase 1

• 1 other identifier: P03700
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Non-resectable, advanced malignant melanoma.

Interventions

GV1001 BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, Postbox 4953, 0424, Norway

Location

MeSH Terms

Conditions

Melanoma

Interventions

GV1001 peptide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 23, 2010
• First Posted: November 24, 2010
• Study Start: January 1, 2005
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2012
• Last Updated: November 5, 2014

Record last verified: 2014-11

Locations

NO (1)