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

This study has been completed.
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
First received: January 7, 2005
Last updated: May 5, 2010
Last verified: May 2010

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 Intervention Phase
Ovarian Cancer
Peritoneal Cavity Cancer
Biological: therapeutic autologous lymphocytes
Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Safety and toxicity [ Designated as safety issue: Yes ]
  • Duration of in vivo persistence [ Designated as safety issue: No ]
  • Antitumor effects [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: October 2004
Study Completion Date: March 2010
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.


Ages Eligible for Study:   18 Years to 75 Years
Genders 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

ClinicalTrials.gov Identifier: NCT00101257     History of Changes
Other Study ID Numbers: 1942.00  FHCRC-1942.00  CDR0000402870 
Study First Received: January 7, 2005
Last Updated: May 5, 2010
Health Authority: United States: Federal Government

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
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on May 26, 2016