Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer

NCT00057915 | Completed Phase 1

• 2 other identifiers: 41805910
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from a person's white blood cells mixed with peptides may make the body build an immune response to kill cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with refractory stage IV cancer.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Safety

  The safety and feasibility of administering one cycle of CAP-1(6D) and CMV pp65 peptide-pulsed, matured, autologous human DC produced by the AastromReplicell™ Cell Production System

  12 months

Secondary Outcomes (1)

• Immune response

  12 weeks

Study Arms (1)

CEA peptide 1-6D

EXPERIMENTAL

CAP-1(6D) peptide-pulsed, matured, autologous human DC produced by the AastromReplicell™ Cell Production System

Biological: CEA peptide 1-6D

Interventions

CEA peptide 1-6D BIOLOGICAL

CAP-1(6D) peptide-pulsed, matured, autologous human DC produced by the AastromReplicell™ Cell Production System

Also known as: carcinoembryonic antigen peptide 1-6D

CEA peptide 1-6D

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed malignancy that is refractory to standard therapy known to have a survival benefit * Stage IV disease * Carcinoembryonic antigen (CEA)-expressing tumor, as evidenced by 1 of the following: * Immunohistochemistry with at least 50% of the tumor with at least moderate intensity of staining * Peripheral blood CEA greater than 2.5 mg/dL * Tumor known to be universally CEA positive (i.e., colon or rectal cancer) * HLA-A201 positive * Measurable disease\* * At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan NOTE: \*Histologic or cytologic confirmation is not required for measurable disease restricted to a solitary lesion * Received at least 1 prior standard chemotherapy regimen known to have a survival benefit * Previously resected brain metastases allowed provided CT scan or MRI was performed within the past month and shows no metastasis PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * More than 6 months Hematopoietic * WBC at least 3,000/mm\^3 * Hemoglobin at least 9 g/dL (transfusions or red blood cell growth factors \[e.g., epoetin alfa\] allowed) * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin less than 2.0 mg/dL (unless patient has Gilbert's disease) * SGOT/SGPT less than 1.5 times upper limit of normal * No hepatic disease that would preclude study participation * No viral hepatitis (including chronic hepatitis) by hepatitis B surface antigen and hepatitis C serology Renal * Creatinine less than 2.5 mg/dL * No urinary tract infection Cardiovascular * No New York Heart Association class III or IV heart disease Immunologic * No history of autoimmune disease, including any of the following: * Inflammatory bowel disease * Systemic lupus erythematosus * Ankylosing spondylitis * Scleroderma * Multiple sclerosis * No active acute or chronic infection * HIV negative Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other serious chronic or acute illness that would preclude study participation * No medical or psychological impediment that would preclude study compliance * No other malignancy within the past 5 years except nonmelanoma skin cancer, controlled carcinoma in situ of the cervix, or controlled superficial bladder cancer * No allergy to study vaccine components PRIOR CONCURRENT THERAPY: Biologic therapy * At least 4 weeks since prior immunotherapy * No other concurrent immunotherapy Chemotherapy * See Disease Characteristics * At least 4 weeks since prior chemotherapy * No concurrent chemotherapy Endocrine therapy * At least 6 weeks since prior steroid therapy (except steroids administered as premedication for chemotherapy or contrast-enhanced studies) * Concurrent hormonal therapy allowed for patients with breast cancer * No concurrent steroid therapy Radiotherapy * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * Not specified Other * Recovered from prior therapy * At least 4 weeks since prior investigational therapy * At least 4 weeks since other prior therapy * Any number of prior therapies are allowed * Concurrent bisphosphonates allowed for bone metastases * No concurrent immunosuppressive therapy (e.g., azathioprine or cyclosporine) * No other concurrent experimental therapies

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, 27705, United States

Location

Study Officials

• Herbert K. Lyerly, MD

  Duke Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2003
• First Posted: April 9, 2003
• Study Start: September 1, 2003
• Primary Completion: August 1, 2006
• Study Completion: September 1, 2006
• Last Updated: September 8, 2014

Record last verified: 2014-09

Locations

US (1)