Cellular Adoptive Immunotherapy in Treating Patients With Stage III or Stage IV Ovarian Cancer or Primary Peritoneal Cancer
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Purpose
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 |
- 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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders 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
Contacts and Locations| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| Study Chair: | Cassian Yee, MD | Fred Hutchinson Cancer Research Center |
More Information
Additional Information:
No publications provided
| 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 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 |
ClinicalTrials.gov processed this record on May 16, 2013