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Cola

aldesleukin

mutant p53 peptide pulsed dendritic cell vaccine

ras peptide cancer vaccine

sargramostim

therapeutic autologous lymphocytes

therapeutic tumor infiltrating lymphocytes

Samir N. Khleif, MD

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.

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.

Vaccine Therapy and Biological Therapy in Treating Patients With Advanced Cancer

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

National Cancer Institute (NCI)

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Nasopharyngeal Carcinoma

Laryngeal Diseases

Laryngeal Cancer

Hypopharyngeal Cancer

Tongue Cancer

Metastatic Squamous Neck Cancer With Occult Primary

tetanus toxoid helper peptide

adjuvant therapy

Robert L. Ferris, MD, PhD

RATIONALE: Vaccines made from a person's dendritic cells mixed with peptides may help the body build an effective immune response to kill tumor cells.

PURPOSE: This randomized phase I trial is studying the side effects of vaccine therapy in treating patients with head and neck cancer.

OBJECTIVES:

Primary

* Determine the toxicity of intranodally injected autologous dendritic cells (DC) loaded with wild-type p53 peptides with or without T-helper peptide epitope in patients with squamous cell carcinoma of the head and neck.

Secondary

* Determine the local and systemic immunomodulatory effects of this vaccine in these patients.

OUTLINE: This is a randomized, pilot study.

Patients undergo leukapheresis. The resulting dendritic cells (DC) are pulsed with wild-type (wt) p53 peptides with or without T-helper (Th) peptides. Individual autologous vaccines are prepared for each patient. Patients who are HLA-A2-DR4-negative are randomized to 1 of 2 treatment arms (arm I or arm II). Patients who are HLA-A2-DR4-positive are assigned to arm III.

* Arm I: Patients receive autologous DC loaded with HLA-A2.1-restricted wt p53 peptides only.
* Arm II: Patients receive autologous DC loaded with HLA-A2.1-restricted wt p53 peptides and Th tetanus toxoid peptide.
* Arm III (HLA-A2-DR4-positive patients only): Patients receive autologous DC loaded with HLA-A2.1-restricted wt p53 peptides and Th wt p53 peptide.

In all arms, each vaccine is administered by ultrasonography-guided inguinal intranodal injection over 30 minutes on days 0, 14, and 28.

After completion of study therapy, patients are followed periodically.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Vaccine Therapy in Treating Patients With Head and Neck Cancer

Adjuvant p53 Peptide Loaded DC-Based Therapy for Subjects With Squamous Cell Cancer of the Head and Neck (A Phase I Safety and Immunogenicity Trial)

Robert Ferris

UPMC Endowed Professor and Chief, Division of Head and Neck Surgery, Department of Otolaryngology

Carcinoma, Bronchogenic

Bronchial Neoplasms

Jay A. Berzofsky, MD, PhD

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: This phase II trial is studying vaccine therapy given after standard therapy to see how well it works in treating patients with stage III non-small cell lung cancer.

OBJECTIVES:

* Determine the overall survival in patients with locally advanced non-small cell lung cancer immunized with adjuvant mutant p53 peptide-pulsed autologous dendritic cells after standard therapy.
* Assess the safety and immunological efficacy of this regimen in terms of inducing or boosting a mutant p53-specific immune response in this patient population.

OUTLINE: Patients undergo p53 gene mutation analysis. Patients without a suitable gene mutation receive no vaccination. Patients with a suitable p53 gene mutation receive mutant p53 peptide-pulsed autologous dendritic cells IV over 1-2 minutes weekly for 5 weeks. Patients achieving an immune response with no evidence of progressive disease may receive additional vaccinations every 2 months for a maximum of 10 immunizations.

Patients are followed for 5 years.

PROJECTED ACCRUAL: Approximately 120 patients (40 on the vaccination arm) will be accrued for this study.

Vaccine Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

Phase II Trial of Individualized Mutant p53 Peptide-Pulsed Cultured Autologous Dendritic Cells in the Adjuvant Treatment of Patients With Locally Advanced Non-Small Cell Lung Cancer After Standard Therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Vaccine Therapy and Biological Therapy in Treating Patients With Advanced Cancer	NCT00019084	Breast Cancer Cervical Cancer Colorectal Canc... Lung Cancer Ovarian Cancer Pancreatic Canc...	aldesleukin mutant p53 pept... ras peptide can... sargramostim therapeutic aut... therapeutic tum...	18 Years -	National Cancer Institute (NCI)
Vaccine Therapy in Treating Patients With Head and Neck Cancer	NCT00404339	Head and Neck C...	mutant p53 pept... tetanus toxoid ... adjuvant therap...	18 Years - 120 Years	University of Pittsburgh
Vaccine Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer	NCT00019929	Lung Cancer	mutant p53 pept... adjuvant therap...	-	National Cancer Institute (NCI)
Vaccine Therapy in Treating Patients With Head and Neck Cancer	NCT00404339	Head and Neck C...	mutant p53 pept... tetanus toxoid ... adjuvant therap...	18 Years - 120 Years	University of Pittsburgh
Vaccine Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer	NCT00019929	Lung Cancer	mutant p53 pept... adjuvant therap...	-	National Cancer Institute (NCI)
Vaccine Therapy in Treating Patients With Head and Neck Cancer	NCT00404339	Head and Neck C...	mutant p53 pept... tetanus toxoid ... adjuvant therap...	18 Years - 120 Years	University of Pittsburgh

Spots Global Cancer Trial Database for mutant p53 peptide pulsed dendritic cell vaccine