Vaccine Therapy and Biological Therapy in Treating Patients With Advanced Cancer
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|ClinicalTrials.gov Identifier: NCT00019084|
Recruitment Status : Completed
First Posted : May 23, 2003
Last Update Posted : June 20, 2013
RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may be an effective treatment for advanced cancer.
PURPOSE: Phase II trial to study the effectiveness of a vaccine made with the patients' white blood cells mixed with tumor proteins in treating patients who have advanced cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Cervical Cancer Colorectal Cancer Lung Cancer Ovarian Cancer Pancreatic Cancer||Biological: aldesleukin Biological: mutant p53 peptide pulsed dendritic cell vaccine Biological: ras peptide cancer vaccine Biological: sargramostim Biological: therapeutic autologous lymphocytes Biological: therapeutic tumor infiltrating lymphocytes||Phase 2|
OBJECTIVES: I. Determine whether endogenous cellular immunity to a particular tumor-specific mutated p53 or ras protein is present in patients with tumors expressing mutant p53 or ras. II. Determine whether vaccination with antigen-presenting cells pulsed in vitro with synthetic peptide corresponding to the tumor's p53 or ras mutation in the presence of sargramostim (GM-CSF) can induce or boost patient cellular immunity to the mutated peptide in this patient population. III. Assess the type and characteristics of the cellular immunity generated. IV. Determine whether in vivo-primed T-cells generated against the p53 or ras mutation, expanded in vitro with corresponding peptide, and infused with subcutaneous interleukin-2 can enhance the activity of specific cytotoxic T-lymphocyte immune response and/or tumor response in these patients.
OUTLINE: Patients are assigned to 1 of 2 treatment regimens. The first 5 patients accrued are assigned to Regimen A. Three weeks after all 5 patients are enrolled, additional patients are accrued and assigned to Regimen B. All patients undergo peptide hypersensitivity testing with the peptide they will be treated with prior to each vaccination. Regimen A: Two days prior to each vaccination, peripheral blood mononuclear cells (PBMC) are harvested. PBMC are incubated for 48 hours with either patient-specific mutant p53 or ras peptide fragments and sargramostim (GM-CSF). The antigen-presenting cells (APC) are irradiated prior to use. APC are reinfused on day 0. Treatment repeats after 3 weeks and then every 6 weeks for a total of 4 vaccinations. Regimen B: Patients are vaccinated with APC as in Regimen A. PBMC are harvested prior to the first APC vaccination and 1 week after the second, third, and fourth APC vaccinations. PBMC are incubated for 7 days with either peptide the patient was vaccinated with (mutant p53 or ras peptide fragments) and interleukin-2 (IL-2). The peptide-activated lymphocytes (PAL) are reinfused over 1 hour 2 weeks after each APC vaccination. Patients receive IL-2 subcutaneously 5 days a week for 2 weeks beginning 4 hours after each PAL infusion. Patients in both regimens with stable or responding disease continue treatment every 6 weeks. Patients achieving complete response continue treatment for up to 1 additional year. Patients are followed at 1 and 2 months.
PROJECTED ACCRUAL: A maximum of 70 patients (5 per Regimen A, 28-65 per Regimen B) will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||VACCINE THERAPY WITH TUMOR SPECIFIC MUTATED P53 OR RAS PEPTIDES ALONE OR IN COMBINATION WITH CELLULAR IMMUNOTHERAPY WITH PEPTIDE ACTIVATED LYMPHOCYTES (PAL CELLS) ALONG WITH SUBCUTANEOUS IL-2|
|Study Start Date :||February 1996|
|Actual Study Completion Date :||May 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00019084
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Samir N. Khleif, MD||National Cancer Institute (NCI)|