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Ovarian CancerPhase 1NCT00019136

Gene Therapy and Biological Therapy in Treating Patients With Ovarian Epithelial Cancer

A Phase 1 study testing MOv-gamma chimeric receptor gene, aldesleukin and therapeutic allogeneic lymphocytes in people with Ovarian Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
MOv-gamma chimeric receptor gene, aldesleukin and therapeutic allogeneic lymphocytes
How many people
Not given
Where
1 siteUnited States
Study dates
Feb 1997to not given
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, 20892-1182

Other trials in United States

About this study

Official title: TREATMENT OF PATIENTS WITH ADVANCED EPITHELIAL OVARIAN CANCER USING ANTI-CD3 STIMULATED PERIPHERAL BLOOD LYMPHOCYTES TRANSDUCED WITH A GENE ENCODING A CHIMERIC T-CELL RECEPTOR REACTIVE WITH FOLATE BINDING PROTEIN

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.

Read the detailed description

OBJECTIVES:

  • Determine the clinical response in patients with advanced ovarian epithelial cancer treated with intravenously administered allogeneic peripheral blood mononuclear cell-stimulated, gene-modified lymphocytes (MOv-PBL).
  • Evaluate the ability of intravenously administered MOv-PBL to traffic to sites of ovarian cancer.
  • Determine the duration of survival of transduced lymphocytes in the systemic circulation and at the tumor site in these patients.

OUTLINE: This is a dose-escalation study. Patients are stratified by eligibility to receive interleukin-2 (IL-2) (yes vs no).

Patients undergo leukapheresis. The collected peripheral blood lymphocytes (PBLs) are stimulated with allogeneic peripheral blood mononuclear cells (PBMCs) followed by retroviral transduction with antiovarian cancer MOv-gamma chimeric receptor gene (MOv-PBL). MOv-PBL are then reinfused IV over 30-60 minutes followed by IL-2 IV over 15-30 minutes every 12 hours for up to 8 doses (if eligible). This course may be repeated at least once, beginning 2-3 weeks later. Patients receiving allogeneic PBMC-stimulated PBLs receive donor PBMCs subcutaneously at 1 and 8 days after each MOv-PBL infusion instead of IL-2.

Cohorts of 3-6 patients in each stratum receive escalating doses of MOv-PBL until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. An additional 10 patients receive MOv-PBL, without IL-2, followed by immunization with donor PBMCs as above.

Patients are followed at 4 and 8 weeks and then periodically for survival.

PROJECTED ACCRUAL: Approximately 13-50 patients will be accrued for this study.

Conditions
Ovarian Cancer
Being tested
MOv-gamma chimeric receptor gene, aldesleukin, therapeutic allogeneic lymphocytes
Keywords
recurrent ovarian epithelial cancer
Medical subject headings
Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MOv-gamma chimeric receptor geneBiological

  • aldesleukinBiological

  • therapeutic allogeneic lymphocytesBiological

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startFeb 1997

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00019136
Sponsor's protocol ID
CDR0000064488
Other IDs
NCI-96-C-0011, NCI-T95-0040N
Status last verified
Dec 2003
First submitted
11 Jul 2001
Last updated
29 Apr 2015
Results posted
No

Publications

  • 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.

    PubMed 33658994

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MOv-gamma chimeric receptor gene, aldesleukin and therapeutic allogeneic lymphocytes in people with Ovarian Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00019136, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2015.

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