Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
OBJECTIVES: * Determine whether endogenous cellular immunity to a tumor-specific mutated ras protein is present in cancer patients. * Determine whether vaccination with synthetic peptides corresponding to the tumor's ras mutation with DetoxPC adjuvant, interleukin-2 (IL-2), and/or sargramostim (GM-CSF) can induce or boost a patient's cellular immunity to that particular mutation. * Determine the type and characteristics of the cellular immune response generated. * Determine the tolerance to and toxicity spectrum of such peptides given with DetoxPC adjuvant along with IL-2 and/or GM-CSF. * Correlate immune response with tumor response in patients treated with these regimens. OUTLINE: Patients are assigned to one of three treatment groups. * Group I (closed to accrual 6/4/01): Patients receive tumor-specific ras peptide vaccine with DetoxPC subcutaneously (SC) once every 5 weeks for 3 courses. Beginning 4 days after vaccination, patients receive interleukin-2 (IL-2) SC 5 days a week for 2 weeks. * Group II (closed to accrual 6/4/01): Patients receive sargramostim (GM-CSF) SC daily beginning 1 day prior to the vaccination and continuing for 4 days. Patients receive the vaccination as in group I immediately followed by GM-CSF on day 2. Patients are vaccinated once every 4 weeks for 3 courses. * Group III: Patients receive the vaccination and IL-2 as in group I and GM-CSF as in group II. In all groups, patients receive up to 15 vaccinations in the absence of disease progression. Patients are followed every 2 months. PROJECTED ACCRUAL: A maximum of 60 patients (20 per treatment group) will be accrued for this study within 2-4 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
