Coxsackie Virus A21 Administered Intravenously (IV) for Solid Tumour Cancers (PSX-X04)

NCT00636558 | Completed Phase 1 DMC

• 2 other identifiers: V937-004PSX-X04
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

Coxsackie A21 (CVA21) virus is to be administered by IV infusion to patients with Stage 4 melanoma, prostate and breast cancer. This is a dose escalation, safety study.

Conditions

Melanoma; Breast Cancer; Prostate Cancer

Keywords

coxsackie virus; melanoma; breast cancer; prostate cancer

Outcome Measures

Primary Outcomes (1)

• The primary objective of the study is to determine the safety and tolerability of CVA21 given by intravenous infusion in multiple escalating doses.

  Days 1, 2, 5, 6, 7, 8, 12, 16, 20, 28, 42, 56, 84

Secondary Outcomes (2)

• To obtain preliminary efficacy data, determine the time course of viraemia and its elimination post-administration of CVA21

  Days 1, 2, 5, 6, 7, 8, 12, 16, 20, 28, 42, 56, 84

• To characterise the time course of the anti-CVA21 antibody response

  Days 1, 2, 5, 6, 7, 8, 12, 16, 20, 28, 42, 56, 84

Study Arms (1)

CVA21

EXPERIMENTAL

IV administration of CVA21 in a dose escalation manner

Drug: CVA21

Interventions

CVA21 DRUG

IV infusion, dose escalation of one or two infusions of escalating strength

Also known as: CAVATAK

CVA21

Eligibility Criteria

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

You may qualify if:

• Patients who are willing and able to provide written informed consent to participate in the study.
• Male or female aged 18 years or older.
• Stage IV solid tumour disease with the primary tumour being any one of the following types - breast, prostate or melanoma.
• ICAM-1 with or without DAF-expressing tumour. Patients without archival material for testing must agree to a new tumour biopsy.
• Absence of circulating antibodies to CVA21 (titre \< 1:16).
• Patients must have failed or refused standard treatment(s).
• Adequate haematological, hepatic and renal function, defined as:
• ANC \> 1.5 x 10\^9/L, platelets \> 100 x 10\^9/L
• Bilirubin \< 20µmol/L, AST \< 2.5 times the upper limit of normal
• Calculated creatinine clearance \> 30 mL/minute
• Adequate immunologic function, defined as:
• Serum IgG \> 5g/L
• T cell subsets within normal limits
• Fertile males and females must agree to the use of an adequate form of contraception. Hormonal contraceptives should be supplemented with an additional barrier method. Negative pregnancy test is required in female patients of child-bearing potential.

You may not qualify if:

• Presence or history of Central Nervous System (CNS) malignancy.
• Patients must not have received chemotherapy within 4 weeks prior to date of consent.
• Performance status \> 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
• Life expectancy \< 6 months.
• Pregnancy or breastfeeding.
• Primary or secondary immunodeficiency, including immunosuppressive disease, and immunosuppressive doses of corticosteroids (e.g. prednisolone \> 7.5mg per day) or other immunosuppressive medications including cyclosporine, azathioprine, interferons, within the past 4 weeks.
• Positive serology for HIV, hepatitis B or hepatitis C.
• Splenectomy.
• Presence of uncontrolled infection.
• Presence of unstable neurological disease.
• Any uncontrolled medical condition that in the opinion of the Investigator is likely to place the patient at unacceptable risk during the study or reduce their ability to complete the study
• Participation in another study requiring administration of an investigational drug or biological agent within the last 4 weeks
• Known allergy to treatment medication or its excipients
• Any other medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.

Sponsors & Collaborators

• Viralytics: lead

Study Sites (2)

Cancer Care Centre, St George Hospital

Kogarah, New South Wales, 2217, Australia

Location

Redcliffe Hospital

Redcliffe, Queensland, 4020, Australia

Location

MeSH Terms

Conditions

Melanoma; Breast Neoplasms; Prostatic Neoplasms; Coxsackievirus Infections

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; Breast Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Boris Chern, MD

  Redcliffe Hospital, Brisbane, Qld., Australia

  PRINCIPAL INVESTIGATOR

• Winston Liauw, MD

  St George Hospital

  PRINCIPAL INVESTIGATOR

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: March 7, 2008
• First Posted: March 14, 2008
• Study Start: February 29, 2008
• Primary Completion: January 12, 2012
• Study Completion: January 12, 2012
• Last Updated: July 1, 2019

Record last verified: 2019-06

Locations

AU (2)