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Ovarian CancerPhase 1NCT00101257

Cellular Adoptive Immunotherapy in Treating Patients With Stage III or Stage IV Ovarian Cancer or Primary Peritoneal Cancer

A Phase 1 study testing therapeutic autologous lymphocytes in people with Ovarian Cancer and Peritoneal Cavity Cancer, run by Fred Hutchinson Cancer Center 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: Biological therapies, such as cellular adoptive immunotherapy, stimulate the immune system in different ways and stop tumor cells from growing. PURPOSE: This phase I trial is studying the side effects and best dose of cellular adoptive immunotherapy in treating patients with stage III or stage IV ovarian… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Ovarian Cancer, Peritoneal Cavity Cancer
What is being tested?
therapeutic autologous lymphocytes
How many people
18 participants
Where
1 siteUnited States
Study dates
Oct 2004to Mar 2010
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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage III or IV ovarian epithelial cancer or primary peritoneal cavity cancer meeting 1 of the following criteria:
  • Progressive* or persistent* disease during or after primary chemotherapy
  • Recurrent disease < 6 months after completion of primary therapy that had resulted in a complete response
  • Persistent* or recurrent disease after second-line or additional therapies NOTE: *Progression or persistence can be based on serological (CA 125 > 100 U/mL OR 2 times baseline), radiographic (measurable or evaluable disease), or second-look surgical findings
  • Tumor expressing NY-ESO-1 determined by IHC or RT-PCR
  • HLA type expressing DPB*0401, DPB1*0201, DRB1*07
  • No CNS metastases

PATIENT CHARACTERISTICS:

Age

  • 18 to 75

Performance status

  • Karnofsky 70-100%

Life expectancy

  • More than 16 weeks

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Creatinine ≤ 2.0 mg/dL

Cardiovascular

  • No congestive heart failure*
  • No clinically significant hypotension*
  • No symptoms of coronary artery disease*
  • No cardiac arrhythmias on EKG requiring drug therapy*
  • No history of cardiovascular disease*
  • No other significant cardiovascular abnormalities* NOTE: *Patients with any of the above undergo a stress test and/or echocardiography before being determined ineligible for study participation

Pulmonary

  • FEV_1 ≥ 60% of predicted*
  • DLCO ≥ 55%* NOTE: *Patients with clinically significant pulmonary dysfunction only

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No active infection
  • No oral temperature > 38.2°C within the past 72 hours
  • No systemic infection requiring chronic maintenance or suppressive therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No other concurrent immunotherapy (e.g., interleukins, interferons, vaccines, intravenous immunoglobulin, or expanded polyclonal tumor-infiltrating lymphocytes or lymphokine-activated killer cell therapy)

Chemotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior standard or experimental chemotherapy

Endocrine therapy

  • No concurrent systemic corticosteroids except for treatment-related toxicity

Radiotherapy

  • At least 3 weeks since prior radiotherapy

Surgery

  • See Disease Characteristics

Other

  • At least 3 weeks since prior immunosuppressive therapy
  • More than 3 weeks since prior investigational drugs and recovered
  • No other concurrent investigational agents
  • No concurrent pentoxifylline

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024

Other trials in United States

About this study

Official title: Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD4+ Antigen-Specific T Cell Clones for Patients With Advanced Ovarian Cancer

RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, stimulate the immune system in different ways and stop tumor cells from growing.

PURPOSE: This phase I trial is studying the side effects and best dose of cellular adoptive immunotherapy in treating patients with stage III or stage IV ovarian cancer or primary peritoneal cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the safety and toxicity of autologous CD4-positive antigen-specific T cells in patients with stage III or IV ovarian epithelial cancer or primary peritoneal cavity cancer.
  • Determine the duration of in vivo persistence of this drug in these patients.

Secondary

  • Determine the antitumor effect of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients undergo leukapheresis for collection of T cells. Responder T cells are stimulated in vitro with autologous peripheral blood mononuclear cell-derived dendritic cells pulsed with NY-ESO-1 immunogenic peptides. Patients receive autologous CD4-positive antigen-specific T cells IV over 30 minutes.

Cohorts of 3-6 patients receive escalating doses of autologous CD4-positive antigen-specific T cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 4, 8, and 12 weeks and then periodically thereafter for survival.

PROJECTED ACCRUAL: A total of 9-18 patients will be accrued for this study.

Being tested
therapeutic autologous lymphocytes
Keywords
recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, peritoneal cavity 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.

  • therapeutic autologous lymphocytesBiological

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and toxicity

  2. Duration of in vivo persistence

  3. Antitumor effects

Timeline

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

  1. First posted10 Jan 2005 (estimated)
  2. Study startOct 2004
  3. Study completionMar 2010

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
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00101257
Sponsor's protocol ID
1942.00
Other IDs
FHCRC-1942.00, CDR0000402870
Status last verified
May 2010
First submitted
7 Jan 2005
Last updated
7 May 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing therapeutic autologous lymphocytes in people with Ovarian Cancer and Peritoneal Cavity Cancer, run by Fred Hutchinson Cancer Center 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 7 May 2010. 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.

What does the primary outcome measure?

Safety and toxicity. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 7 May 2010.

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