EUCTR2008-006140-20-GBActive, not recruitingPhase 1
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
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- BioVex Inc
- Enrollment
- 437
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
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;
- •multiple injectable melanoma lesions which in aggregate have a longest diameter of = 10 mm.
- •6.Serum LDH levels = 1.5 x ULN.
- •7.ECOG Performance Status of 0 or 1.
- •8.Life expectancy >4 months from the date of randomization.
- •9.Provide written informed consent in accordance will all applicable regulations and follow the study procedures. Patients must be capable of understanding the investigational nature, potential risks and benefits of the study.
- •10.Adequate organ function determined within 4 weeks prior to randomization, defined further in the protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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
- •7.Baseline prolongation of QT/QTc interval (QTc interval >470 msec).
- •8.Open herpetic skin lesions.
- •9.Pregnant or breast-feeding female. Confirmation that women of child-bearing potential are not pregnant. A negative serum or urine ß-human chorionic gonadotropin (ß-hCG) pregnancy test result must be obtained during the screening period.
- •10. Fertile males and females who are unwilling to employ adequate means of contraception (e.g., condom with spermicide, diaphragm with spermicide, birth control pills, injections, patches, or intrauterine device) during study treatment and through 30 days after the last dose of study treatment.
- •11.Previous treatment with OncoVEXGM-CSF or treatment with GM-CSF for active disease (prior adjuvant therapy with GM-CSF is permitted).
- •12.Currently enrolled in another clinical research study or received an investigational agent for any reason within 4 weeks prior to randomization.
- •13.Require intermittent or chronic treatment with an anti-herpetic drug (e.g., acyclovir), other than intermittent topical use.
Investigators
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