Biological Therapy in Treating Patients With Advanced Cancer

NCT00005956 | Completed

• 4 other identifiers: 130965421528CDR0000067937
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: A person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have advanced cancer that shows no signs of disease following treatment.

Conditions

Breast Cancer; Gastric Cancer; Ovarian Cancer

Keywords

stage II breast cancer; stage IV breast cancer; stage IIIA breast cancer; stage II gastric cancer; stage III gastric cancer; stage IV gastric cancer; stage IIIB breast cancer; stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer

Outcome Measures

Primary Outcomes (1)

• Safety

  safety

  12 months

Interventions

HER-2/neu intracellular domain protein BIOLOGICAL

Also known as: HER2 ICD

therapeutic autologous dendritic cells BIOLOGICAL

Also known as: DC

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed advanced malignancy that expresses HER2/neu * Stage IIA breast cancer with more than 6 positive lymph nodes * Stage IIB, IIIA, or IIIB breast cancer * Stage III ovarian cancer * Lymph node positive gastric cancer * Metastatic tumor * No measurable or evaluable disease after standard treatment * No previously irradiated or newly diagnosed CNS metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Menopausal status: * Not specified Performance status: * Karnofsky 80-100% Life expectancy: * Greater than 6 months Hematopoietic: * WBC at least 3,000/mm\^3 * Hemoglobin at least 9 mg/dL * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL * No hepatic disease, including viral hepatitis Renal: * Creatinine less than 2.5 mg/dL Cardiovascular: * No New York Heart Association class III or IV heart disease Pulmonary: * No asthma or chronic obstructive pulmonary disease Immunologic: * Must have positive intradermal delayed hypersensitivity test for at least 1 of the following: * Candida * Mumps * Tetanus * Trichophyton * Histoplasmin * No prior autoimmune disease including, but not limited to, the following: * Inflammatory bowel disease * Systemic lupus erythematosus * Ankylosing spondylitis * Scleroderma * Multiple sclerosis Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * Hepatitis B surface antigen and hepatitis C antibody negative * No other concurrent serious chronic or acute illness or infection (including urinary tract infection) * No known shellfish or iodine allergy * No other prior or concurrent malignancy except for nonmelanoma skin cancer, cervical cancer, or controlled superficial bladder cancer * No medical or psychological condition that may preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * No other concurrent immunotherapy Chemotherapy: * At least 4 weeks since prior chemotherapy and recovered * No concurrent chemotherapy Endocrine therapy: * Concurrent hormonal therapy allowed (tamoxifen, raloxifene, toremifene, and all aromatase inhibitors) * At least 4 weeks since prior steroid or immunosuppressive therapy (e.g, azathioprine or cyclosporine) Radiotherapy: * Prior radiotherapy allowed except to cranium * At least 4 weeks since prior radiotherapy and recovered * At least 12 weeks since prior strontium chloride Sr 89 * No concurrent radiotherapy Surgery: * At least 4 weeks since prior surgery and recovered Other: * Concurrent bisphosphonates allowed * No prior hepatitis B immunization

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

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Morse MA, Hobeika A, Osada T, Niedzwiecki D, Marcom PK, Blackwell KL, Anders C, Devi GR, Lyerly HK, Clay TM. Long term disease-free survival and T cell and antibody responses in women with high-risk Her2+ breast cancer following vaccination against Her2. J Transl Med. 2007 Sep 6;5:42. doi: 10.1186/1479-5876-5-42.

  PMID: 17822557 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Stomach Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland 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

• Michael A. Morse, MD

  Duke Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: May 21, 2003
• Study Start: February 1, 2000
• Primary Completion: August 1, 2001
• Study Completion: July 1, 2002
• Last Updated: July 9, 2014

Record last verified: 2013-03

Locations

US (1)