E10A for the Treatment of Squamous Cell Carcinoma of the Head and Neck

NCT02630264 | Unknown Phase 3

• 1 other identifier: E10AIII
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

Brief Summary

Recombinant human endostatin adenovirus injection is a novel anti-tumor gene therapy drug. E10A contains a recombinant human endostatin gene with the second-generation recombinant adenovirus as its vector. After transfection tumor cells. E10A expresses human endostatin, which inhibits vascular endothelial cell proliferation and tumor angiogenesis, and blocks tumor blood supply, thereby specifically inhibiting tumor growth and inducing apoposis of tumor cells. Both pre-clinical and animal models have demonstrated the anti-tumor activities of E10A. The safety and efficacy of E10A in treating head and neck cancer has also been demonstrated in Phase I and Phase II studies.

Conditions

Head and Neck Neoplasms

Keywords

clinical trial; Recombinant Human Endostatin Adenovirus; randomized

Outcome Measures

Primary Outcomes (1)

• Time to progression

  Time to progression is defined as the time from randomization until objective tumor progression as verified for the first time

  Up to 24 weeks

Secondary Outcomes (4)

• Change in Overall response rate (CR+PR)

  Up to 24 weeks, from date of randomization until the date of first documented progression

• Chang in disease control rate (CR+PR+SD)

  Up to 24 weeks, From date of randomization until the date of first documented progression

• Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)

  Up to 32 weeks, from date of randomization until the date of first documented progression or date

• Overall survival

  Up to 24 month, through study completion

Study Arms (2)

Combination therapy

EXPERIMENTAL

E10A+chemotherapy group (360 subjects): 1. E10A (Endostatins) of 1.0×1012VP on day 1 and 6 2. Paclitaxel Injection 160mg/m2 on day 3 3. Cisplatin Injection 25mg/m2 on day 3, 4, and 5. Repeat every 21 days.

Drug: Endostatins; Drug: Paclitaxel injection; Drug: Cisplatin injection

Chemotherapy

EXPERIMENTAL

Chemotherapy-alone group (180 subjects): 1. Paclitaxel Injection 160mg/m2 on day 1 2. Cisplatin Injection 25mg/m2 on day 1, 2, and 3. Repeat every 21 days

Drug: Paclitaxel injection; Drug: Cisplatin injection

Interventions

Endostatins DRUG

Specification: 1mL/division, 1×1012 VP/1.0mL E10A preparation: 1. Thaw frozen E10A stored at -20°C vials at room temperature until E10A is liquid. 2. Swirl gently. Do NOT shake. Method of administration 1. E10A was diluted with 0.9% sodium chloride to appropriate dose according to the longest diameter of the target lesion. 2. After local anesthesia, we penetrated the syringe under normal skin subcutaneously 5 mm into the tumor or vertically into the lymph node under direct visualization and withdrew it to confirm the absence of blood. 3. Applied local compression for 10 minutes and pasted a sterile sticker on the injection site to avoid bleeding.

Also known as: E10A

Combination therapy

Paclitaxel injection DRUG

Specification: 30mg/5mL, Usage: 160mg/m2 on day 3, according to instruction.

Chemotherapy; Combination therapy

Cisplatin injection DRUG

Specification: 20mg Usage: Cisplatin 25mg/ m2 on day 3, 4, and 5,according to instruction.

Chemotherapy; Combination therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years with histologically or cytologically proven locoregionally advanced or metastatic HNSCC (excluding NPC) not suitable for operation or radiotherapy
• A life expectancy≧12 weeks.
• Patients were required to have at least one measurable (by imaging or photograph complied RECIST) lesion with the largest diameter ≧2 cm and suitable for the intratumoral injection of E10A,
• Not received chemotherapy, radiotherapy, or biotherapy within 4 weeks.
• Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-2.
• Adequate bone marrow,renal, and liver functions.

You may not qualify if:

• Known allergies to the study drug.
• The presence of important blood vessels/nerves or ulceration in the target lesion not suitable for injection.
• Tumor relapses within 6 months after paclitaxel chemotherapy.
• Severe coagulation disorders or bleeding tendency.
• Severe uncontrolled medical conditions.
• Recent history of myocardial infarction acute infection, pregnancy or lactation, or symptomatic brain metastases
• A history of corticosteroids or immunosuppressives use within four weeks of study entry
• Received any chemotherapy or radiotherapy within four weeks of study entry

Sponsors & Collaborators

• Guangzhou Double Bioproducts Co., Ltd: lead

Study Sites (1)

Guangzhou DB

Gaungzhou, Guangdong, 510663, China

RECRUITING

Related Publications (2)

• Ye W, Liu R, Pan C, Jiang W, Zhang L, Guan Z, Wu J, Ying X, Li L, Li S, Tan W, Zeng M, Kang T, Liu Q, Thomas GR, Huang M, Deng W, Huang W. Multicenter randomized phase 2 clinical trial of a recombinant human endostatin adenovirus in patients with advanced head and neck carcinoma. Mol Ther. 2014 Jun;22(6):1221-1229. doi: 10.1038/mt.2014.53. Epub 2014 Mar 25.

  PMID: 24662947 RESULT

• Lin X, Huang H, Li S, Li H, Li Y, Cao Y, Zhang D, Xia Y, Guo Y, Huang W, Jiang W. A phase I clinical trial of an adenovirus-mediated endostatin gene (E10A) in patients with solid tumors. Cancer Biol Ther. 2007 May;6(5):648-53. doi: 10.4161/cbt.6.5.4004. Epub 2007 Feb 13.

  PMID: 17426445 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Endostatins; Paclitaxel; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Angiostatic Proteins; Angiogenic Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Collagen Type XVIII; Non-Fibrillar Collagens; Collagen; Extracellular Matrix Proteins; Scleroproteins; Biological Factors; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Huiqiang Huang, Ph.D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huiqiang Huang, Ph.d

CONTACT

(86)2087343350; huanghq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2013
• First Posted: December 15, 2015
• Study Start: June 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 15, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)