A Safety and Efficacy Study of Intetumumab, Alone and in Combination With Dacarbazine, in Participants With Stage 4 Melanoma

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and effectiveness of the intetumumab, alone and in combination with dacarbazine, in patients with stage 4 melanoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centocor, Inc.
• Collaborator: Janssen-Cilag Farmaceutica, S.R.L.
• Treatments: Antibodies, Monoclonal; Dacarbazine; Intetumumab

Criteria

Inclusion Criteria:

• Histologically confirmed melanoma including ocular and mucosal

• Documented AJCC (American Joint Committee on Cancer) Stage 3 unresectable or Stage 4 melanoma (Phase 1); AJCC Stage 4 melanoma (Phase 2)

• Radiographically measurable disease or measurable skin lesions

• Prior chemotherapy for metastatic melanoma will be allowed for Phase 1, while previously untreated for melanoma by chemotherapy will be allowed for Phase 2

• Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

• History of receiving murine or human/murine recombination products of human αν integrins

• Known human immunodeficiency virus (HIV) positivity and clinically important active infection

• Presence of bone metastases or malignant effusions (non-measurable lesions) and central nervous system metastases

• Prior radiation to target lesions

• Concurrent immunotherapy, biotherapy, radiotherapy, chemotherapy, or investigational therapy and therapeutic use of anticoagulation