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

NCT00101257 | Completed Phase 1

• 3 other identifiers: 1942.00FHCRC-1942.00CDR0000402870
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer; Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; peritoneal cavity cancer

Outcome Measures

Primary Outcomes (3)

• Safety and toxicity

• Duration of in vivo persistence

• Antitumor effects

Interventions

therapeutic autologous lymphocytes BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Cassian Yee, MD

  Fred Hutchinson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 7, 2005
• First Posted: January 10, 2005
• Study Start: October 1, 2004
• Study Completion: March 1, 2010
• Last Updated: May 7, 2010

Record last verified: 2010-05

Locations

US (1)