A Study of Recombinant Vaccinia Virus to Treat Malignant Melanoma

NCT00429312 | Completed Phase 1 DMC

• 1 other identifier: JX594-IT-MEL005
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this research study is to find out whether JX-594 (Pexa-Vec) is safe and effective for treating surgically unresectable malignant melanoma.

Conditions

Melanoma

Keywords

Melanoma; Oncolytic virus; Pexa-Vec

Outcome Measures

Primary Outcomes (1)

• Response rate for injected tumor(s)

  Initial response assessment at 6 weeks

Secondary Outcomes (4)

• Safety, as determined by incidence of treatment-related adverse events, serious adverse events (SAEs), and clinically-significant changes from baseline in routine laboratory parameters

  Safety evaluation throughout study period

• Best overall response for entire disease burden (RECIST criteria)

  Initial response assessment after six weeks

• Progression-free survival (PFS)

  Follow-up every three weeks until new therapy or disease progression

• Response rate of non-injected tumor(s)

  Initial response assessment at six weeks

Study Arms (1)

Single Arm

EXPERIMENTAL

Intratumoral injection(s) of Recombinant Vaccinia GM-CSF, JX-594

Biological: JX-594

Interventions

JX-594 BIOLOGICAL

Thymidine kinase-deleted vaccinia virus plus GM-CSF

Also known as: JX594

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically-confirmed, Stage 3 or Stage 4 malignant melanoma
• At least one tumor mass measurable by CT/MRI and/or physical examination that can be injected by direct visualization or by ultrasound-guidance
• Anticipated survival of at least 16 weeks
• Cancer is not surgically resectable for cure
• KPS score of ≥ 70 (refer to APPENDIX E: KARNOFSKY PERFORMANCE STATUS (KPS))
• Age ≥18 years
• Men and women of reproductive potential must be willing to follow accepted birth control methods during treatment and for 3 months after the last treatment with JX-594
• The ability to understand and willingness to sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form
• Able to comply with study procedures and follow-up examinations
• Adequate liver function: Total bilirubin ≤ 2.0 x ULN; AST, ALT ≤ 2.0 x ULN
• Adequate bone marrow function: WBC \> 3,500 cells/mm3 and \< 50,000 cells/mm3; ANC \> 1,500 cells/mm3; Hemoglobin \> 10 g/dL; Platelet count \> 125,000 plts/mm3
• Acceptable coagulation status: INR \< (ULN + 10%)
• Acceptable kidney function: Serum creatinine \< 2.0 mg/dL

You may not qualify if:

• Target tumor(s) adherent to and/or invading a major vascular structure (e.g. carotid artery)
• Pregnant or nursing an infant
• Known infection with HIV
• Systemic corticosteroid or other immunosuppressive medication use within 4 weeks of first treatment with JX-594
• Clinically significant active infection or uncontrolled medical condition (e.g. pulmonary, neurological, cardiovascular, gastrointestinal, genitourinary) considered high risk for investigational new drug treatment Significant immunodeficiency due to underlying illness and/or medication (e.g. systemic corticosteroids)
• History of eczema that at some stage has required systemic therapy
• Clinically significant and/or rapidly accumulating ascites, peri-cardial and/or pleural effusions (e.g. requiring drainage for symptom control)
• Severe or unstable cardiac disease which includes, but is not limited to, any of the following within 6 months prior to screening: myocardial infarct, unstable angina, congestive heart failure, myocarditis, arrhythmias diagnosed and requiring medication, or any clinically-significant change in cardiac status
• Treatment of the target tumor(s) with radiotherapy, chemotherapy, surgery, or an investigational drug within 4 weeks of screening (6 weeks in case of mitomycin C or nitrosoureas)
• Experienced a severe reaction or side-effect as a result of a previous smallpox vaccination
• Inability or unwillingness to give informed consent or comply with the procedures required in this protocol
• Patients with household contacts who are pregnant or nursing an infant, children \< 5 years old, have history of eczema that at some stage has required systemic therapy, or have a significant immunodeficiency due to underlying illness (e.g. HIV) and/or medication (e.g. systemic corticosteroids) will be excluded unless alternate living arrangements can be made during the patient's active dosing period and for three weeks following the last dose of study medication.

Sponsors & Collaborators

• Jennerex Biotherapeutics: lead

Study Sites (3)

UCLA

Los Angeles, California, 90095, United States

Location

Billings Clinic

Billings, Montana, 59101, United States

Location

Cancer Center of the Carolinas

Greenville, South Carolina, 29605, United States

Location

Related Publications (1)

• Mastrangelo MJ, Maguire HC Jr, Eisenlohr LC, Laughlin CE, Monken CE, McCue PA, Kovatich AJ, Lattime EC. Intratumoral recombinant GM-CSF-encoding virus as gene therapy in patients with cutaneous melanoma. Cancer Gene Ther. 1999 Sep-Oct;6(5):409-22. doi: 10.1038/sj.cgt.7700066.

  PMID: 10505851 BACKGROUND

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• James Burke, M.D.

  Billings Clinic

  PRINCIPAL INVESTIGATOR

• David H Kirn, M.D.

  Jennerex Biotherapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2007
• First Posted: January 31, 2007
• Study Start: March 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: December 1, 2009
• Last Updated: January 15, 2015

Record last verified: 2010-03

Locations

US (3)