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CompletedNCT00101257Updated May 7, 2010

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

A Phase 1 interventional study of therapeutic autologous lymphocytes in Ovarian Cancer and Peritoneal Cavity Cancer, sponsored by Fred Hutchinson Cancer Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-05-07.

Sponsored by Fred Hutchinson Cancer Center · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
18
Ages
18 Years to 75 Years
Sex
Female
01

Study 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.

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.

02

Conditions studied

  • Ovarian Cancer
  • Peritoneal Cavity Cancer

Keywords

  • recurrent ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • peritoneal cavity cancer
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's planned enrollment of 18 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Enrollment
18 participants (estimated)

Interventions

  • Biologicaltherapeutic autologous lymphocytes
06

What researchers measure

Primary outcomes

  1. Safety and toxicity

  2. Duration of in vivo persistence

  3. Antitumor effects

07

Study locations

1 site
  • Fred Hutchinson Cancer Research Center
    Seattle, Washington 98109-1024, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00101257
Lead sponsor
Fred Hutchinson Cancer Center
First posted
Jan 10, 2005
Start date
Oct 2004
Completion
Mar 2010
Last update
May 7, 2010

Study contacts

Cassian Yee, MD
study chair · Fred Hutchinson Cancer Center
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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