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
Roswell Park Cancer Institute
PRIMARY OBJECTIVES: * To determine the clinical efficacy (progression free survival \[PFS\]) of combining temozolomide and SVN53-67/M57-KLH peptide vaccine (SurVaxM) in patients with progressing NECs. * To evaluate the safety and toxicity of the study drug combination (temozolomide + SurVaxM) in patients with progressing NECs. SECONDARY OBJECTIVES: I. To assess clinical benefit (including complete response, partial response and stable disease as defined by Response Evaluation Criteria in Solid Tumors \[RECIST\] version \[v\]1.1) at 3 months, 6 months, 9 months, and 12 months from study entry. II. To assess anti-survivin IgG titer response. EXPLORATORY OBJECTIVES: I. To explore immune markers associated with clinical responses to SurVaxM in peripheral blood of NETs patients. II. To assess the methylguanine methyltransferase (MGMT) status of all patients and correlate with response. III. To assess the tumor growth rate (TGR) on radiographic imaging prior to study enrollment and while on study. OUTLINE: Patients receive temozolomide orally (PO) once daily (QD) on days 1-5. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity and can be continued at investigators discretion at end of treatment. Patients also receive SurVaxM with incomplete Freund's adjuvant (montanide ISA-51) subcutaneously (SC) and sargramostim SC once every 2 weeks for 4 doses. Patients with clinical benefit after 4 doses of SurVaxM and remain free of tumor progression and unacceptable toxicity may receive 3 additional doses on weeks 24, 36, and 48. Additionally, patients undergo blood sample collection, computed tomography (CT) scans or magnetic resonance imaging (MRI) scans throughout study. After completion of study treatment, patients are followed up at 30 days.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
