Efficacy and Safety Study of OncoVEXGM-CSF Compared to GM-CSF in Melanoma - Full Text View

Sponsor:	BioVex Limited
Information provided by:	BioVex Limited
ClinicalTrials.gov Identifier:	NCT00769704

Purpose

This study is being conducted to learn about the safety and risks of using OncoVEXGM-CSF to treat patients with melanoma and to see if OncoVEXGM CSF can destroy these tumours compared to GM-CSF. This study may provide information on the usefulness of OncoVEXGM-CSF as a future treatment for melanoma. This study may also provide information on the safety and usefulness of GM-CSF as compared to OncoVEXGM-CSF as a treatment for melanoma.

Condition	Intervention	Phase
Melanoma	Biological: OncoVEXGM-CSF Biological: GM-CSF	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Treatment With OncoVEXGM-CSF Compared to Subcutaneously Administered GM-CSF in Melanoma Patients With Unresectable Stage IIIb, IIIc and IV Disease

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim

U.S. FDA Resources

Further study details as provided by BioVex Limited:

Primary Outcome Measures:

Achieving a statistically significant improvement in durable response rate, defined as the rate of CR or PR lasting continuously for 6 or more months, as compared to control therapy. [ Time Frame: Every 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate overall survival in patients treated with OncoVEXGM-CSF as compared to control therapy. [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	430
Study Start Date:	April 2009
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 OncoVEXGM-CSF	Biological: OncoVEXGM-CSF Up to 4 mL of 10^8 pfu/mL/per injection Other Name: OncoVEXGM-CSF
Active Comparator: 2 GM-CSF	Biological: GM-CSF 125 µg/m2 daily subcutaneously for 14 consecutive days followed by 14 days of rest Other Names: GM-CSF Leukine Sargramostim

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females age ≥ 18 years
Stage IIIb, IIIc or stage IV disease that is not surgically resectable
Injectable disease (i.e. suitable for direct injection or through the use of ultrasound guidance)
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
Serum LDH levels less than 1.5 x ULN
ECOG Performance Status of 0 or 1
Prolongation in INR, PT, and PTT when the result is from therapeutic anticoagulation treatment are permitted for patients whose injectable lesions are cutaneous and/or subcutaneous such that direct pressure could be applied in the event of excessive bleeding

Exclusion Criteria:

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769704

Show 83 Study Locations

Sponsors and Collaborators

BioVex Limited

Investigators

Study Director:

Howard Goldsweig, MD

BioVex Limited

More Information

Additional Information:

Sponsor Website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Robert Coffin, PhD, BioVex
ClinicalTrials.gov Identifier:	NCT00769704 History of Changes
Other Study ID Numbers:	005/05
Study First Received:	October 7, 2008
Last Updated:	July 14, 2011
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by BioVex Limited:

Melanoma
OncoVEXGM-CSF
GM-CSF

Stage IIIb, IIIc and IV Disease
oncolytic
OncoVex

Additional relevant MeSH terms:

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on February 08, 2012