Consolidation Therapy in Patients With Hematologic Malignancies

Cancer Clinical Trial

Official title: Phase I/II Study of Low-Dose Cyclophosphamide, Tumor Associated Peptide Antigen-Pulsed Dendritic Cell Therapy and Low Dose GM-CSF, As Consolidation Treatment in Patients With Hematologic Malignancies

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to determine the safety and efficacy of Tumor Associated Peptide Antigen (TAPA) pulsed dendritic cell (DC) vaccines in the treatment of hematologic malignancies.

Clinical Trial Description

Patients diagnosed with hematologic malignancies (as defined) who have responded to conventional therapy, and without any potentially curative therapeutic intervention, will be candidates for this Phase I/II study. Following confirmation of disease response to conventional antineoplastic therapy, eligible patients who agree to participate and sign a consent form will have their tumor cells and/or blood analyzed for the expression of a specific panel of Tumor Associated Peptide Antigens (TAPAs), including SP17, Ropporin, AKAP4, PTTG1 and Span-xb. Patients whose tumors express one (1) or more of these TAPAs will receive three (3) days of subcutaneous Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) to increase bone marrow production of monocytes and dendritic cell (DC) precursors, and peripheral blood mononuclear cells will be obtained by phlebotomy and/or leukapheresis for generation of autologous DCs. Patient's DCs will be generated at Kiromic's Cell Processing Good Manufacturing Process (GMP) facility, according to established Standard Operating Procedures, and activated by pulsing/loading them with the TAPA(s) relevant for each particular patient. Patients will receive five (5) days of low-dose cyclophosphamide prior to each vaccination with TAPA-pulsed DCs to decrease Treg activity. TAPA-pulsed DCs will be administered at a fixed dose of up to 1 x 107 DCs at least two (2) days following cyclophosphamide administration. DC vaccination schedule will be once every fourteen (14) days via subcutaneous (SC) and intradermal (ID) injections for a total of 6 vaccinations. Low dose GM-CSF will also be administered SC for five (5) consecutive days, starting three (3) to six (6) hours after each TAPA-pulsed DC treatment, to optimize immune response and DC viability in vivo. Patients will be followed on a weekly basis (or more frequently if required) to evaluate treatment-related toxicity. Immune responses and anti-tumor responses will be evaluated per protocol specifications. Continuation and stopping rules for the study will be defined based on toxicity/tolerability (Phase I) and/or immune responses (Phase II). ;

Related Conditions & MeSH terms

• Cancer
• Hematologic Malignancies
• Neoplasms

• NCT number: NCT02709993
• Study type: Interventional
• Source: Kiromic, Inc.
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: July 28, 2017
• Completion date: October 31, 2020