Cellular Adoptive Immunotherapy in Treating Patients With Stage III or Stage IV Ovarian Cancer or Primary Peritoneal Cancer
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ClinicalTrials.gov Identifier: NCT00101257 |
Recruitment Status
:
Completed
First Posted
: January 10, 2005
Last Update Posted
: May 7, 2010
|
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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 |
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.
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 |

- Safety and toxicity
- Duration of in vivo persistence
- Antitumor effects

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

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 ClinicalTrials.gov identifier (NCT number): NCT00101257
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109-1024 |
Study Chair: | Cassian Yee, MD | Fred Hutchinson Cancer Research Center |
ClinicalTrials.gov Identifier: | NCT00101257 History of Changes |
Other Study ID Numbers: |
1942.00 FHCRC-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 Neoplasms 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 |