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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00101257
Recruitment Status : Completed
First Posted : January 10, 2005
Last Update Posted : May 7, 2010
Information provided by:
Fred Hutchinson Cancer Research Center

Brief 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 cancer or primary peritoneal cancer.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Peritoneal Cavity Cancer Biological: therapeutic autologous lymphocytes Phase 1

Detailed Description:



  • 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.


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Primary Purpose: Treatment
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
Study Start Date : October 2004
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Safety and toxicity
  2. Duration of in vivo persistence
  3. Antitumor effects

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • 18 to 75

Performance status

  • Karnofsky 70-100%

Life expectancy

  • More than 16 weeks


  • Not specified


  • Not specified


  • Creatinine ≤ 2.0 mg/dL


  • 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


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


  • 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


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)


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

Endocrine therapy

  • No concurrent systemic corticosteroids except for treatment-related toxicity


  • At least 3 weeks since prior radiotherapy


  • See Disease Characteristics


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00101257

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Study Chair: Cassian Yee, MD Fred Hutchinson Cancer Research Center Identifier: NCT00101257     History of Changes
Other Study ID Numbers: 1942.00
CDR0000402870 ( Registry Identifier: PDQ )
First Posted: January 10, 2005    Key Record Dates
Last Update Posted: May 7, 2010
Last Verified: May 2010

Keywords provided by Fred Hutchinson Cancer Research Center:
recurrent ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
peritoneal cavity cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases