A Study of OncoVEXGM-CSF in Stage IIIc and Stage IV Malignant Melanoma

This study has been completed.
Sponsor:
Collaborator:
Symbion Research International
Information provided by (Responsible Party):
BioVex Limited
ClinicalTrials.gov Identifier:
NCT00289016
First received: February 8, 2006
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to learn about the safety and the risks of using OncoVEXGM-CSF to treat Stage IIIc and Stage IV melanoma and to determine whether OncoVEXGM-CSF is effective in destroying tumors.


Condition Intervention Phase
Melanoma
Genetic: Oncolytic viral vector
Procedure: Vaccine Therapy
Procedure: Immune-modulator therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of the Efficacy, Safety and Immunogenicity of OncoVEXGM-CSF in Patients With Stage IIIc and Stage IV Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by BioVex Limited:

Primary Outcome Measures:
  • To assess the clinical efficacy of OncoVEXGM-CSF in terms of tumour response rates, median survival time and time to disease progression. [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the safety of OncoVEXGM-CSF in terms of adverse events, clinical pathology and biodistribution and antibody responses to the vector. [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • To assess the efficacy of OncoVEXGM-CSF in terms of immunological anti-tumour responses and in terms of time to tumour responses. [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: October 2005
Intervention Details:
    Genetic: Oncolytic viral vector
    The drug is an injection of up to 4 mLs every 14 days +/- 3 days.
    Procedure: Vaccine Therapy
    The drug is an injection of up to 4 mLs every 14 days +/- 3 days.
    Procedure: Immune-modulator therapy
    The drug is an injection of up to 4 mLs every 14 days +/- 3 days.
Detailed Description:

The OncoVEXGM-CSF vector is replication competent herpes simplex type-1 virus used for the treatment of solid tumours.

  Eligibility

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

Inclusion Criteria:

  1. Patients with histologically proven stage IIIc (including two or more palpable lymph nodes, extracapsular or in-transit metastases) or stage IV melanoma that is not eligible for curative surgery and who have one or more tumours that are accessible for direct injection.
  2. Tumours 0.5 to 10 cm in the longest diameter that are suitable for injection (i.e. not bleeding or weeping).
  3. Serum LDH levels <= 2.0 times the upper limit of normal.
  4. Aged 18 years or more.
  5. Performance status (ECOG) 0 or 1.
  6. Clinically immunocompetent.
  7. Recovered from prior therapy with at least 4 weeks since the last exposure to chemotherapy or radiotherapy.
  8. Total white cell count >= 3.0 x 10^9/L, platelet count >= 80 x 10^9/L.
  9. Serum creatinine <= 0.2 mmol/L.
  10. Bilirubin <= 1.5 times the upper limit of the normal range, AST/ALT equal to or less than twice the upper limit of the normal range and alkaline phosphatase equal to or less than twice the upper limit of the normal range.

Exclusion Criteria:

  1. Participation in any previous melanoma immunotherapy trial within one month prior to entry to this trial or any trial of any other investigational agent within the last month prior to entry to this trial.
  2. Tumours to be injected lying in mucosal regions or close to an airway, major blood vessel or spinal cord that, in the opinion of the Investigators, could cause occlusion or compression in the case of tumour swelling or erosion into a major vessel in the case of necrosis.
  3. Pregnancy, lactation or lack of effective contraception in women of child-bearing potential; lack of effective contraception in men if the partner is of child-bearing potential; women must have been practising an effective contraceptive method for at least three months prior to entry in to the trial (hormonal contraception or intrauterine device in conjunction with a barrier method OR surgically sterilised). Men must use a condom or be surgically sterilised.
  4. Major surgery within the 14 days prior to entry to the trial.
  5. Intercurrent serious infections within the 28 days prior to entry to the trial.
  6. Life-threatening illness unrelated to cancer.
  7. Treatment with antiviral agents within the 14 days prior to entry to the trial.
  8. Uncontrolled congestive cardiac failure.
  9. Clinically active autoimmune disease.
  10. Dermatoses involving or near to the tumours to be injected. Limb tumours may not be injected if active dermatoses are present on the same limb. Trunk and head and neck tumours must not be injected if dermatoses are present within 50 cm of the tumour.
  11. Known to test positive for HIV, hepatitis B or C or syphilis.
  12. Patient only has injectable tumours that are not potentially resectable in the case of tumour necrosis or swelling.
  13. Previous history of malignancies of other types that have occurred or recurred within the previous 5 years with the exception of cone biopsied carcinoma of the cervix.
  14. Corticosteroid use.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289016

Locations
United States, California
UCSD Cancer Center, Thornton Hospital
La Jolla, California, United States, 92093
UCLA
Los Angeles, California, United States, 90095
United States, Colorado
University of Colorado, Anschutz Cancer Pavillion
Aurora, Colorado, United States, 80010
United States, Minnesota
Hubert H Humphrey Cancer Center
Robbinsdale, Minnesota, United States, 55422
United States, New Jersey
Mountainside Hospital
Montclair, New Jersey, United States, 07042
United States, New York
Columbia University, Department of Surgery
New York, New York, United States, 10032
United States, Texas
Mary Crowely Medical Research Center
Dallas, Texas, United States, 75246
United Kingdom
Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
BioVex Limited
Symbion Research International
Investigators
Principal Investigator: John Nemunaitis, MD Mary Crowley Medical Research Center
Study Director: Rob Coffin, PhD BioVex Limited
  More Information

No publications provided

Responsible Party: BioVex Limited
ClinicalTrials.gov Identifier: NCT00289016     History of Changes
Other Study ID Numbers: ONCOVEX GM-CSF 002/03
Study First Received: February 8, 2006
Last Updated: February 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by BioVex Limited:
gene transfer
gene therapy
oncolytic virus
GM-CSF
melanoma

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
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014