NCT00870181

Brief Summary

Malignant gliomas are the most common primary brain tumor in adults, but the prognosis for patients with these tumors remains poor despite advances in diagnosis and standard therapies such as surgery, radiation therapy, and chemotherapy. The advantages of ADV-TK gene therapy highlight its efficacy and safety for glioma patients. This clinical trial was conducted to assess the anti-tumor efficacy and safety of intraarterial cerebral infusion of replication-deficient adenovirus mutant ADV-TK, in combination with systemic intravenous GCV administration in patients with recurrent high-grade glioma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 27, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 25, 2013

Status Verified

June 1, 2013

Enrollment Period

3.9 years

First QC Date

March 26, 2009

Last Update Submit

June 22, 2013

Conditions

Malignant Glioma of BrainGlioblastoma

Outcome Measures

Primary Outcomes (1)

  • The primary end point was 6-month progression-free survival rate (PFS-6)

    6 months

Secondary Outcomes (4)

  • progression-free survival (PFS)

    3 years

  • overall survival (OS)

    3 years

  • safety

    1. at the time during treatments; 2. at 6-month; 3. at the end of 1-year following-up; 4. at the end of 2-year following up; 5. at the time the patient censored.

  • clinical benefit

    at the end of 2nd ADK-TK/GCV therapy

Study Arms (2)

ADV-TK/GCV

EXPERIMENTAL

ADV-TK was administered via intraarterial cerebral infusion. Systemic GCV therapy was delivered at a dose of 5mg/kg intravenous, every 12 h at 36 hours after ADV-TK therapy.

Biological: ADV-TK/GCV

Control group

ACTIVE COMPARATOR

Patients received surgery or systemic chemotherapy or palliative care.

Procedure: SurgeryDrug: systemic chemotherapy

Interventions

ADV-TK/GCVBIOLOGICAL

gene therapy

ADV-TK/GCV
SurgeryPROCEDURE
Control group
systemic chemotherapyDRUG
Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed WHO grades 3 to 4 malignant glioma
  • Diagnosed recurrence or progression by clinical or radiological evidence
  • Fit for intraarterial infusion and intravenous chemotherapy
  • Adequate hepatic, renal, and hematologic function.
  • Legal age ≥18 years
  • Life expectancy ≥12 weeks
  • Eastern Cooperative Oncology Group performance (ECOG) ≥2
  • Chemotherapy completion ≥4 weeks prior and recovery from drug induced toxicities.

You may not qualify if:

  • Active pregnancy
  • Prior gene therapy
  • Second primary tumor
  • Gravidity, lactation, hypersensitivity to antiviral drugs, immunologic deficit, active uncontrolled infections
  • Requiring treatment with warfarin or any other anticoagulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing YouAn Hospital

Beijing, Beijing Municipality, 100069, China

Location

Related Publications (1)

  • Ji N, Weng D, Liu C, Gu Z, Chen S, Guo Y, Fan Z, Wang X, Chen J, Zhao Y, Zhou J, Wang J, Ma D, Li N. Adenovirus-mediated delivery of herpes simplex virus thymidine kinase administration improves outcome of recurrent high-grade glioma. Oncotarget. 2016 Jan 26;7(4):4369-78. doi: 10.18632/oncotarget.6737.

    PMID: 26716896DERIVED

MeSH Terms

Conditions

Glioblastoma

Interventions

Surgical Procedures, OperativeNeoadjuvant Therapy

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Study Officials

  • Ma Ding, M.D.

    Tongji Hospital of HUST

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Gynecology and Obstetrics

Study Record Dates

First Submitted

March 26, 2009

First Posted

March 27, 2009

Study Start

January 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

June 25, 2013

Record last verified: 2013-06

Locations

CN(1)