NCT00019136

Brief Summary

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill ovarian cancer cells. Interleukin-2 combined with white blood cells that are gene-modified to recognize and kill ovarian cancer cells may be an effective treatment for recurrent or residual ovarian cancer. PURPOSE: Phase I trial to study the effectiveness of interleukin-2 plus gene-modified white blood cells in treating patients who have advanced ovarian epithelial cancer.

Trial Health

80
On Track

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1997

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

April 29, 2015

Status Verified

December 1, 2003

First QC Date

July 11, 2001

Last Update Submit

April 28, 2015

Conditions

Ovarian Cancer

Keywords

recurrent ovarian epithelial cancer

Interventions

MOv-gamma chimeric receptor geneBIOLOGICAL
aldesleukinBIOLOGICAL
therapeutic allogeneic lymphocytesBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven recurrent, resected recurrent, or residual ovarian epithelial cancer * Failed prior standard effective therapy including cisplatin/carboplatin or paclitaxel * Tumor positive for folate-binding protein by monoclonal antibody MOv18 binding * Measurable disease by CT scan, MRI, ultrasound, or physical exam OR * Minimal residual disease on laparotomy, laparoscopy, or peritoneal washings (i.e., disease not evaluable radiologically or on physical exam) PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0 or 1 Hematopoietic: * WBC greater than 3,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 9.0 g/dL * No coagulation disorder Hepatic: * Bilirubin no greater than 2.0 mg/dL * Other liver function tests less than 3 times upper limit of normal * Hepatitis B antigen negative Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No major cardiovascular illness * If history of ischemic heart disease, congestive heart failure, or cardiac arrhythmias, not eligible to receive interleukin-2 Pulmonary: * FEV\_1 and DLCO greater than 70% predicted * No major respiratory illness Immunologic: * Must have an intact immune system as evidenced by a positive reaction to Candida albicans, mumps, or tetanus toxoid skin tests on a standard anergy panel * HIV negative * No active systemic infection Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * More than 2 weeks since prior biologic therapy Chemotherapy: * See Disease Characteristics * More than 2 weeks since prior chemotherapy Endocrine therapy: * More than 2 weeks since prior endocrine therapy * No concurrent steroids Radiotherapy: * More than 2 weeks since prior radiotherapy Surgery: * See Disease Characteristics * Prior debulking allowed

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

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (1)

  • Pinte L, Cunningham A, Trebeden-Negre H, Nikiforow S, Ritz J. Global Perspective on the Development of Genetically Modified Immune Cells for Cancer Therapy. Front Immunol. 2021 Feb 15;11:608485. doi: 10.3389/fimmu.2020.608485. eCollection 2020.

    PMID: 33658994DERIVED

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

aldesleukin

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 Officials

  • Steven A. Rosenberg, MD, PhD

    NCI - Surgery Branch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

February 1, 1997

Last Updated

April 29, 2015

Record last verified: 2003-12

Locations

US(1)