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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


Phase 1
18 Years
75 Years
Not Enrolling
Female
Ovarian Cancer, Peritoneal Cavity Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Safety and toxicity

Safety Issue:

Yes

Principal Investigator

Cassian Yee, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1942.00

NCT ID:

NCT00101257

Start Date:

October 2004

Completion Date:

March 2010

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109