Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
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.
Detailed description
OBJECTIVES: * Determine the safety and feasibility of administering 1 or 2 courses of vaccination with carcinoembryonic antigen peptide 1-6D (CAP 1-6D)- and CMV pp65 peptide-pulsed autologous dendritic cells in patients with refractory stage IV CEA-expressing malignancies. * Determine the ability of this regimen to induce CAP 1-6D- and CMV pp65-specific T cells in these patients. * Determine the antitumor effect of this regimen, in terms of progression-free survival, of these patients. OUTLINE: This is an open-label, dose-escalation study. Patients undergo leukapheresis and collection of peripheral blood mononuclear cells from which dendritic cells (DC) are generated and pulsed with carcinoembryonic antigen peptide 1-6D (CAP 1-6D) and CMV pp65 peptide. Patients are assigned to 1 of 2 vaccination cohorts. * Cohort I: Patients receive vaccination with CAP 1-6D-pulsed DC and CMV pp65 peptide-pulsed DC subcutaneously and intradermally every 3 weeks for a total of 4 vaccinations. * Cohort II: Patients receive vaccinations as in cohort I every 3 weeks for a total of 8 vaccinations. For both cohorts, a safe dose of the vaccine is defined as the dose at which no more than 1 of 6 patients experiences unacceptable toxicity. Patients are followed every 3 months for 1 year. PROJECTED ACCRUAL: A total of 12 patients (6 per cohort) will be accrued for this study within 24 months.
Interventions
CAP-1(6D) peptide-pulsed, matured, autologous human DC produced by the AastromReplicell™ Cell Production System
Sponsors
Study design
Eligibility
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immune response | 12 weeks | The ability of the epitope pulsed DC to induce CAP-1(6D) and CMV pp65-specific T cells |
Countries
United States