Efficacy Study on the Transfer of Adenovirus With the CD40 Ligand Gene (AdcuCD40L) to Patients With Esophageal Carcinoma

NCT00504322 | Withdrawn Phase 1 DMC

• 1 other identifier: 0502007770
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a randomized, double-blinded assessment of biologic efficacy of AdcuCD40L. The individuals enrolled in this study will be individuals with biopsy proven resectable esophageal carcinoma. The dose of the AdcuCD40L vector (administered endoscopically directly to the tumor) will be the highest tolerable dose (most likely 10\^11 particle units) determined from Weill-IRB protocol #0011004683 dose escalation study.

Conditions

Esophageal Neoplasms

Keywords

Esophageal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Expression of CD40L and cytokines

  5-15 days

Study Arms (2)

placebo

PLACEBO COMPARATOR

The placebo will be the salt water-sugar solution used as a vehicle for the vector.

Genetic: Placebo

AdcuCD40L

ACTIVE COMPARATOR

Using Weill-IRB protocol #0011004683 dose escalation study to determine the highest non-toxic dose of the AdcuCD40L vector, this dose (likely 10\^11 particle units) will be used for all individuals enrolled in this efficacy study. Since there is no evidence that delay of surgery for solid tumors for 15 days following diagnosis alters the prognosis, surgery for removal of the primary tumor will be carried out at either 5 or 15 days after administration of the vector (n= 12/group, including n=6 receiving the AdcuCD40L vector, and n=6 receiving placebo). This will permit assessment of the resulting data (in a randomized, blinded fashion) and the biologic responses to the AdCUCD40L vector over time.

Genetic: AdcuCD40L

Interventions

AdcuCD40L GENETIC

Using Weill-IRB protocol #0011004683 dose escalation study to determine the highest non-toxic dose of the AdcuCD40L vector, this dose (likely 10\^11 particle units) will be used for all individuals enrolled in this efficacy study. Since there is no evidence that delay of surgery for solid tumors for 15 days following diagnosis alters the prognosis, surgery for removal of the primary tumor will be carried out at either 5 or 15 days after administration of the vector (n= 12/group, including n=6 receiving the AdcuCD40L vector, and n=6 receiving placebo). This will permit assessment of the resulting data (in a randomized, blinded fashion) and the biologic responses to the AdCUCD40L vector over time.

Also known as: Active Comparator

AdcuCD40L

Placebo GENETIC

The placebo will be the salt water-sugar solution used as a vehicle for the vector.

Also known as: salt water-sugar solution

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be capable of providing informed consent
• Males and females, age 18 to 75 years
• Hematocrit \> 30%
• WBC \< 10,000
• Normal prothrombin, partial thromboplastin time; platelet count \> 100,000
• Normal liver-related serum parameters
• Blood urea nitrogen \< 60 mg/dL, creatinine \< 2.5 mg/dl
• No evidence of active infection of any type, including with adenovirus, hepatitis virus (A, B or C), or human immunodeficiency virus
• No evidence of central nervous system, major psychiatric, musculoskeletal, or immune disorder
• No allergy to the vehicle used to suspend the virus or contrast materials used in radiographic procedures
• Fertile or infertile individuals; it will be recommended that fertile individuals utilize barrier birth control measures to prevent pregnancy during and for 1 month following the administration of the vector
• Biopsy proven esophageal cancer; clinically stage I-III, deemed resectable by the patient's surgeon. No history of neoadjuvant chemotherapy or chemoradiotherapy. Distant metastases are to be ruled out at the discretion of the physician treating the patient according to standards of care
• Individuals not receiving experimental medications or participating in another experimental protocol for at least 4 weeks prior to entry to the study
• The study individual must be able to undergo the procedures in the protocol
• Willingness to participate in the study

You may not qualify if:

• Individuals in whom participation in the study would compromise the normal care and expected progression of their disease
• Individuals receiving corticosteroids or other immunosuppressive medications; previous splenectomy or radiation to the spleen; autoimmune disease
• Recent (less than 6 week) cerebral vascular accident
• Recent (less than 6 week) transmural myocardial infarction
• Evidence of infection defined by elevated white blood cell count, temperature \> 38.5oC or infiltrate on chest x-ray
• Cervical esophageal cancer
• Gastric cancer (tumor more than 50% in the stomach as determined by endoscopy)
• Pathology other than squamous cell or adenocarcinoma
• Malignant ventricular arrhythmia
• Pregnancy
• Immunodeficiency disease, including evidence of HIV infection
• Current alcohol or drug abuse
• Esophageal tumor too small for adequate tissue harvest (determined during esophagoscopy at the time of vector or placebo injection)

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Ronald G. Crystal, MD

  Department of Genetic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2007
• First Posted: July 20, 2007
• Study Start: July 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: May 4, 2016

Record last verified: 2016-05