NCT00034138

Brief Summary

The study will compare the pharmacokinetic profile of OvaRex MAb-B43.13 ascites fluid product and OvaRex MAb-B43.13 cell culture product. Safety and immune responses following treatment with the cell culture product will be evaluated.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2002

Longer than P75 for phase_1

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2002

Completed
5.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

December 18, 2007

Status Verified

December 1, 2007

First QC Date

April 23, 2002

Last Update Submit

December 13, 2007

Conditions

Ovarian Neoplasms

Keywords

immunotherapymonoclonalantibodyStage III ovarian epithelial cancerStage IV ovarian epithelial cancer

Interventions

oregovomabDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological diagnosis of epithelial adenocarcinoma of ovarian, tubal or peritoneal origin.
  • FIGO Stage III or IV prior to study.
  • Serum CA125 level \>35 U/mL prior to or at initial surgery. Alternatively, serum CA125 level \> or = 100 U/mL following surgery or immunohistochemical evidence of tumor tissue expressing CA125.
  • Completed primary treatment following initial diagnosis, including chemotherapy involving a cisplatin or carboplatin-based regimen.
  • Functional Performance Status \< or = 2 by ECOG scale.
  • Medical assessment consistent with prognosis for an expected survival of at least 3 months.
  • Voluntary participation, signed informed consent and willingness to complete all study procedures.

You may not qualify if:

  • No surgery (not including minor surgical procedures), chemotherapy, or radiotherapy (whole abdomen, abdominopelvic or pelvic) within 4 weeks prior to first dose of study drug.
  • No known refractory or recurrent disease requiring chemotherapy during the 4 weeks prior to, or planned 10 weeks after first study dose.
  • Serum CA125 levels not \>800 U/mL at baseline evaluation.
  • No gross (clinically evident) ascites.
  • No immunotherapy (interferons, tumor necrosis factor, other cytokines or biological response modifiers, or BCG vaccines) within the previous 4 weeks of first study dose.
  • No previous treatment with murine monoclonal antibodies for diagnostic or therapeutic purposes or serum human anti-murine antibodies (HAMA) not above upper limit of normal at baseline evaluation.
  • Not on long-term chronic treatment with immunosuppressive drugs such as cyclosporin, ACTH, or corticosteroids.
  • Ovarian tumors must be of low malignant potential or with noninvasive disease.
  • No concurrent malignancy (except non-melanoma of the skin or in situ carcinoma of cervix), unless curative treatment was received and patient has been disease-free for \> or = 5 years.
  • No known allergy to murine proteins, or prior documented anaphylactic reaction to any drug, or known hypersensitivity to diphenhydramine or other antihistamines of similar chemical structure.
  • No previous splenectomy.
  • No active autoimmune disease (e.g., rheumatoid arthritis, SLE, ulcerative colitis, Chrohn's Disease, MS, ankylosing spondylitis).
  • No recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; no acquired, hereditary, or congenital immunodeficiencies.
  • No uncontrolled diseases or illness other than this cancer.
  • No significant cardiovascular abnormalities including uncontrolled hypertension, uncontrolled angina, uncontrolled arrhythmias, or CHF (NYHA Classes II-IV).
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Women's Cancer Research Foundation

Miami, Florida, 33143, United States

Location

Walt Disney Memorial Cancer Institute

Orlando, Florida, 32804, United States

Location

St. Joseph's Medical Center

South Bend, Indiana, 46634, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Magee-Women's Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Baptist Hospital of East Tennessee

Knoxville, Tennessee, 37920, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Mary Babb Randolph Cancer Center

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

oregovomab

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 23, 2002

First Posted

April 24, 2002

Study Start

March 1, 2002

Study Completion

December 1, 2007

Last Updated

December 18, 2007

Record last verified: 2007-12

Locations

US(8)