A Randomized Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Treatment with OncoVEX GM-CSF Compared to Subcutaneously Administered GM-CSF in Melanoma Patients with Unresectable Stage IIIb, IIIc and IV Disease

BioVex Inc0 sites437 target enrollmentApril 28, 2009

Conditionsnresectable Stage IIIb, IIIc and IV Melanoma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: nresectable Stage IIIb, IIIc and IV Melanoma
Sponsor: BioVex Inc
Enrollment: 437
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 28, 2009

End Date

August 8, 2014

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

BioVex Inc

Eligibility Criteria

Inclusion Criteria

•1\.Males or females age \= 18 years.
•2\.Histologically confirmed diagnosis of malignant melanoma.
•3\.Stage IIIb, IIIc or stage IV disease that is not surgically resectable.
•4\.Measurable disease defined as:
•at least 1 melanoma lesion that can be accurately and serially measured in at least 2 dimensions and for which the greatest diameter is \= 10 mm as measured by contrast\-enhanced or spiral computed tomography (CT) scan for visceral or nodal/soft tissue disease (including lymph nodes) and/or;
•at least 1 \= 10 mm superficial cutaneous melanoma lesion as measured by calipers and/or;
•at least 1 \= 10 mm subcutaneous melanoma lesion and/or;
•multiple superficial melanoma lesions which in aggregate have a total diameter of \= 10 mm.
•5\.Injectable disease (i.e. suitable for direct injection or through the use of ultrasound guidance) defined as:
•at least 1 injectable cutaneous, subcutaneous or nodal melanoma lesion \= 10 mm in longest diameter or;

Exclusion Criteria

•1\.Clinically active cerebral or any bone metastases. Patients with up to 3 (neurological performance status of 0\) cerebral metastases may be enrolled, provided that all lesions have been adequately treated with stereotactic radiation therapy, craniotomy, gammaknife therapy, with no evidence of progression, and have not required steroids, for at least two (2\) months prior to randomization.
•2\.Greater than 3 visceral metastases (this does not include lung metastases or nodal metastases associated with visceral organs). For patients with \= 3 visceral metastases, no lesion \>3 cm, and liver lesions must meet RECIST criteria for SD for at least 1 month prior to randomization.
•3\.Any underlying medical condition, which in the opinion of the investigator, would make administration of the study drugs hazardous or make it difficult to monitor adverse effects.
•4\.History of second cancer unless disease\-free for \>5 years. In the case of malignancies that are diagnosed at a stage where a definitive therapy results in near certain cure, a disease free interval of \<5 years is permissible. The Medical Monitor must approve such patients.
•5\. Primary ocular or mucosal melanoma.
•6\. Evidence of immunosuppression for any reason:
•known HIV disease
•acute or chronic active hepatitis B or hepatitis C infection
•chronic oral or systemic steroid medication use at a dose of \>10mg/day of prednisone or equivalent (steroids with low systemic absorption \[e.g., triamcinolone hexacetonide] injected into a joint space is allowed)
•other signs or symptoms of clinical immune system suppression