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A Phase I Study of AD5.SSTR/TK.RGD; A Tropism Modified Adenovirus Vector for Intraperitoneal Delivery of Therapeutic Genes and Additional Capability of Noninvasive Imaging of Gene Transfer in Patients With Recurrent Ovarian and Other Selected Gynecologic Cancers (Infectivity Enhanced Adenoviral Vectors for Ovarian CA)


Phase 1
19 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

A Phase I Study of AD5.SSTR/TK.RGD; A Tropism Modified Adenovirus Vector for Intraperitoneal Delivery of Therapeutic Genes and Additional Capability of Noninvasive Imaging of Gene Transfer in Patients With Recurrent Ovarian and Other Selected Gynecologic Cancers (Infectivity Enhanced Adenoviral Vectors for Ovarian CA)


Inclusion Criteria:



- Patients must have histologically documented invasive epithelial ovarian,
extraovarian, fallopian tube or endometrial carcinoma.

- Patients must have persistent or recurrent disease after standard debulking/staging
surgery and conventional therapy.

- Patients must have evidence of intraabdominal disease; disease may be measurable or
nonmeasurable.

- Patients must have a GOG performance status of 0, 1, or 2, and have a life expectancy
of greater than 3 months.

- Patients must have adequate hematologic, renal, and hepatic function defined as:

- WBC > 3,000 ul

- Granulocytes > 1,500 ul

- Platelets > 100,000

- Creatinine clearance > 80 mg/dl or serum creatinine > 2.0

- Serum transaminases < 2.5 x upper limits of normal

- Normal serum bilirubin

- PT/PTT/INR < 1.5 x institutional ULN

- O2 saturation > or = 92 %

- Patients must be 19 years or older and must have signed informed consent

Exclusion Criteria:

- Patients with epithelial tumors of low malignant potential, stromal tumors and germ
cell tumors of the ovary are ineligible to participate in the study.

- Patients with the only site of disease located beyond the abdominal cavity are
ineligible to participate in the study.

- Patients who are pregnant or lactating are ineligible to participate in the study.

- Patients with a GOG performance status of 3 or 4 are ineligible to participate in the
study.

- Patients with active heart disease (characterized by angina, unstable arrhythmia,
congestive heart failure or EF < 55%, pulmonary hyper- tension, active or chronic
debilitating pulmonary disease(i.e., active pneumonia, severe COPD, pulmonary edema,
O2 saturation < 92%), or coagulation disorders (i.e. bleeding disorders, or on
therapeutic anti- coagulants)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluation for toxicity

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Ronald D Alvarez, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Food and Drug Administration

Study ID:

F080807013 (UAB 0821)

NCT ID:

NCT00964756

Start Date:

August 2009

Completion Date:

April 2012

Related Keywords:

  • Ovarian Cancer
  • ovarian cancer
  • Recurrent ovarian cancer and other gynecologic cancers
  • Ovarian Neoplasms

Name

Location

University of Alabama at BirminghamBirmingham, Alabama  35294-3300