NCT00058435

Brief Summary

RATIONALE: Vaccines made from monoclonal antibodies combined with tumor cells may make the body build an immune response to kill tumor cells. PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have ovarian epithelial, fallopian tube, or peritoneal cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Dec 2002

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2003

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

1.2 years

First QC Date

April 7, 2003

Last Update Submit

June 4, 2013

Conditions

Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer

Keywords

stage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent ovarian epithelial cancerfallopian tube cancerprimary peritoneal cavity cancer

Interventions

abagovomabBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial, fallopian tube, or peritoneal cancer * Stage II-IV * Initially treated with surgery and at least 1 platinum-based chemotherapy regimen * Must have relapsed after initial treatment and completed chemotherapy for recurrent disease * Asymptomatic residual measurable disease on CT scan and/or an elevated CA 125 allowed * Complete clinical remission allowed, defined by the following criteria: * CA 125 no greater than 35 IU/mL * No objective evidence of disease by CT scan * Normal physical examination PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * At least 3 months Hematopoietic * WBC at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic * Bilirubin no greater than 2 times normal * ALT no greater than 2 times normal * Alkaline phosphatase no greater than 2 times normal Renal * Creatinine no greater than 1.5 times normal Other * Not pregnant or nursing * No potential for child bearing * Human antimurine antibody negative * HIV negative * No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No active infection * No known autoimmune disease (e.g., rheumatoid arthritis or ulcerative colitis) * No known immune deficiency (e.g., hypogammaglobulinemia) * No known allergy to murine proteins PRIOR CONCURRENT THERAPY: Biologic therapy * At least 6 weeks since prior interferon * At least 6 weeks since prior immunotherapy or biological response modifiers * No prior anticancer vaccine Chemotherapy * See Disease Characteristics * At least 3 weeks since prior cytotoxic or investigational chemotherapy Endocrine therapy * No concurrent steroids Radiotherapy * At least 4 weeks since prior radiotherapy Surgery * See Disease Characteristics Other * At least 1 week since prior antibiotics * No concurrent cyclosporine * No other concurrent immunosuppressive therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Fallopian Tube NeoplasmsOvarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

abagovomab

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFallopian Tube DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Paul Sabbatini, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2003

First Posted

April 9, 2003

Study Start

December 1, 2002

Primary Completion

March 1, 2004

Study Completion

March 1, 2004

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

US(1)