NCT00006041

Brief Summary

RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill the tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have ovarian, 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 Feb 2000

Typical duration for phase_1

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

February 1, 2000

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2000

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2002

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

June 28, 2004

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

2 years

First QC Date

July 5, 2000

Last Update Submit

June 17, 2013

Conditions

Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancerfallopian tube cancerprimary peritoneal cavity cancer

Interventions

MUC1-KLH conjugate vaccineBIOLOGICAL
MUC1-KLH vaccine/QS21BIOLOGICAL
QS21BIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed ovarian, fallopian tube, or peritoneal epithelial cancer (any stage at diagnosis) Prior cytoreductive surgery required Refractory or recurrent after at least one prior regimen of platinum based chemotherapy No evidence of disease following salvage chemotherapy, defined as: CA125 less than 35 units Negative physical examination No evidence of disease on CT scan of abdomen and pelvis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin, SGOT, and alkaline phosphatase less than 2 times normal Renal: Creatinine less than 1.6 mg/dL Creatinine clearance at least 50 mL/min Other: No other concurrent active invasive malignancy No seafood allergy No positive stool guaiac (excluding hemorrhoids) PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

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

saponin QA-21V1

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
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2000

First Posted

June 28, 2004

Study Start

February 1, 2000

Primary Completion

February 1, 2002

Study Completion

February 1, 2002

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

US(1)