Know Cancer

or
forgot password

A Phase I Study of a Tropism Modified Conditionally Replicative Adenovirus Vector (Ad5-Delta 24 RGD)for Intraperitoneal Delivery in Ovarian and Extraovarian Cancer Patients (Infectivity Enhanced Virotherapy for Ovarian Cancer)


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

Thank you

Trial Information

A Phase I Study of a Tropism Modified Conditionally Replicative Adenovirus Vector (Ad5-Delta 24 RGD)for Intraperitoneal Delivery in Ovarian and Extraovarian Cancer Patients (Infectivity Enhanced Virotherapy for Ovarian Cancer)


Inclusion Criteria:



- Patients must have histologically documented invasive epithelial ovarian or
extra-ovarian adenocarcinoma

- Patients must have persistent or recurrent disease after standard debulking/staging
surgery and conventional chemotherapy.Prior chemotherapy must have included a
taxane/platinum based regimen

- 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, cardiac, pulmonary, coagulation, and
hepatic function defined as:

1. WBC> 3,000 ul

2. Granulocytes> 1,500 ul

3. Platelets> 100,000

4. Creatinine clearance (actual or calculated) >80 mg/dl or serum creatinine <2.0

5. Serum transaminases <2.5x upper limits of normal

6. Normal serum bilirubin

7. PT/PTT/INR < 1.5 x institutional ULN

8. Ejection fraction on echocardiogram > 55%

9. O2 saturation > 92%

- Patients must be 19 years or older (as mandated by Alabama state law) and must have
signed informed consent

Exclusion Criteria:

- Patients with epithelial ovarian tumors of low malignant potential (with or without
invasive implants), with ovarian stromal tumors, or with 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 hypertension), active or chronic
debilitating pulmonary disease (i.e., active pneumonia, severe COPD, pulmonary edema,
O2 saturation < 92%), or coagulation disorders (i.e., bleeding disorders, on
therapeutic anti-coagulants)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine maximum tolerated dose and spectrum of toxicities of Ad5-Delta24RGD

Outcome Time Frame:

1 month

Safety Issue:

Yes

Principal Investigator

Ronald D Alvarez, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Alabama at Birmingham

Authority:

United States: Food and Drug Administration

Study ID:

F061005016 (UAB 0643)

NCT ID:

NCT00562003

Start Date:

June 2007

Completion Date:

June 2010

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cancer
  • Ovarian cancer study
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

Name

Location

UAB Highlands, 1201 11th Ave S, 4th Floor, Gynecologic OncologyBirmingham, Alabama  35205