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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00137878
Other study ID # GV-001.007
Secondary ID
Status Completed
Phase Phase 2
First received August 26, 2005
Last updated February 22, 2012

Study information

Verified date May 2011
Source GenVec
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if the addition of TNFerade™ to pre-operative chemoradiotherapy increases the number of pathologic complete responses when compared to pre-operative chemoradiotherapy alone as assessed following complete surgical resection of primary rectal cancer.


Other known NCT identifiers
  • NCT00069147
  • NCT00072241

Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients who have biopsy proven T3 or T4 rectal cancer which is confined to the primary tumor site with or without regional lymph node involvement

- Patients must be willing to return for follow-up

- Patients must be able to give and sign informed consent

- Patients must be suitable candidates for surgical resection post-chemoradiation, i.e. no history of severe congestive heart failure or severe pulmonary disease

- Life expectancy > 6 months

Exclusion Criteria:

- Patients with evidence of distant metastatic disease

- Any of the following hematologic abnormalities: hemoglobin (HGB) < 8.0 gm/dL unable to be corrected with a transfusion; absolute neutrophil count (ANC) < 1500 cells/mm3; platelets < 100,000/mm3; activated partial thromboplastin time (APTT) ratio or International Normalized Ratio (INR) > 1.5 (except in patients who are therapeutically anticoagulated for non-related medical conditions such as atrial fibrillation and whose anti-thrombotic treatment cannot be withheld for vector injection or surgery).

- A history of hepatic cirrhosis or present hepatic dysfunction with total bilirubin > 2.0 mg/dL except for patients with Gilbert's syndrome who must have a direct bilirubin </= 1.0 mg/dL; AST/ALT >/= 2.5 times upper limit of normal.

- Renal insufficiency as determined by a serum creatinine > 2.0 mg/dL

- Patients may not have received prior therapy with chemotherapy, biologic therapy or radiation therapy for rectal cancer

- Significant history of a medical problem that would preclude the patient from undergoing an operative procedure such as a history of severe congestive heart failure or active ischemic heart disease

- Concurrent second malignancy requiring systemic therapy

- Pregnant or lactating women

- Chronic systemic corticosteroid use

- Prior surgery for rectal cancer

- Patients with history of deep venous thrombosis or pulmonary embolism

- Patients with Doppler evidence of deep venous thrombosis at screening

- Known history of documented coagulopathy or thrombophilic disorders

- Hormone replacement therapy within one month prior to Day 1

- Known history of documented cerebrovascular disease, stroke or transient ischemic attack (TIA)

- Surgery within the last one month, excluding diverting colostomy or ileostomy for obstruction

Study Design

Allocation: Randomized, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
TNFerade™


Locations

Country Name City State
United States Center for Cancer Research, NCI Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
GenVec

Country where clinical trial is conducted

United States, 

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