Clinical Trials Logo
  1. Home
  2. Colorectal Cancer Metastatic
  3. NCT02380443

AlloStim® Immunotherapy Dosing Alone or in Combination With Cryoablation in Metastatic Colorectal Cancer

Colorectal Cancer Metastatic Clinical Trial

Official title:
In-Situ Cancer Vaccine: Phase IIA, Open-Label Study to Assess the Safety of AlloStim® Immunotherapy Alone and in Combination With Cryoablation as Third Line Therapy for Metastatic Colorectal Cancer

Clinical Trial Summary

This is a single center, open label dose frequency escalation study of CryoVax®. personalized anti-tumor vaccine protocol combining the cryoablation of a selected metastatic lesion with intra-lesional immunotherapy with AlloStim®. The in-situ (in the body) cancer vaccine step combines killing a single metastatic tumor lesion by use of cryoablation in order to cause the release of tumor-specific markers to the immune system and then injecting bioengineered allogeneic immune cells (AlloStim®) into the lesion as an adjuvant in order to modulate the immune response and educate the immune system to kill other tumor cells where ever they reside in the body.

Clinical Trial Description

Colorectal cancer (CRC) ranks as the third most common cancer worldwide. Metastasis is the main reason of death in CRC patients. The current drugs used to treat colorectal cancer provide important treatment options for patients, their limitations including drug resistance, poor efficacy and severe side effects. Development of new therapeutic strategies for KRAS mutant as well as BRAF mutant tumors are therefore highly needed in order to offer a new category of drug (immunotherapy). This study targets the population of mCRC patients that have progressed after two lines of chemotherapy and are not eligible for targeted therapies. The study will assess six different dosing schedules. A standard 3 plus 3 study design will be used. The starting frequency for each dosing schedule will be escalated in subsequent groups of patients. The study will evaluate safety of increased frequency of AlloStim® dosing and anti-tumor effect of the new proposed dose and frequency schedule. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02380443
Study type Interventional
Source Immunovative Therapies, Ltd.
Contact
Status Completed
Phase Phase 2
Start date September 2016
Completion date September 2018
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03941080 - Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer
Completed NCT03213314 - HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies N/A
Completed NCT03647839 - Modulation Of The Tumour Microenvironment Using Either Vascular Disrupting Agents or STAT3 Inhibition in Order to Synergise With PD1 Inhibition in Microsatellite Stable, Refractory Colorectal Cancer Phase 2
Recruiting NCT05057052 - Cryoablation Combined With Sintilimab Plus Regorafenib In Previously Treated Colorectal Cancer Liver Metastasis Phase 2
Terminated NCT02316496 - Rechallenge of Cetuximab Combined With Irinotecan as Third-line Chemotherapy in Patients With Metastatic Colorectal Cancer - Phase II Study Phase 2
Completed NCT03251612 - Predictive Value of Drug Sensitivity Testing Tumorspheres From Patients With Metastatic Colorectal Cancer Phase 2
Recruiting NCT02149784 - Effectiveness Study of Resection of Primary Tumor in Stage IV Colorectal Cancer Patients Phase 3
Recruiting NCT01959061 - Efficacy and Safety of Raltitrexed-based Transarterial Chemoembolisation(TACE)for Colorectal Cancer Liver Metastases Phase 4
Terminated NCT01668680 - Maintenance Metronomic Chemotherapy for Metastatic Colorectal Carcinoma Phase 2
Recruiting NCT05068531 - Early Detection of Treatment Failure in Metastatic Colorectal Cancer Patients
Not yet recruiting NCT04525807 - Precision Medicine for Colorectal Cancer Liver Metastasis Guided by Multi-omics Data Under the Umbrella Theory
Completed NCT04482608 - The mCRC Patients With pMMR/MSS or dMMR/MSI-H Status Received Palliative Chemotherapy Efficacy and Survival
Recruiting NCT03193710 - The Effects of General Anesthetics on Lymphocytes in Patients Undergoing Colorectal Cancer Resection and Mechanism Involved N/A
Recruiting NCT04854213 - PRELUDE-1 (Prospective Evaluation of Radiotherapy-induced Biologic Effects in Colorectal Cancer Oligometastatic Patients With LUng-limited Disease: Evolution of Cancer Genetics and Regulatory Immune Cells) N/A
Suspended NCT04108481 - Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer Phase 1/Phase 2
Completed NCT03144804 - A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer Phase 2
Completed NCT03142516 - FOLFIRI + Panitumumab First-line Treatment in Elderly Patients With Unresectable Metastatic Colorectal Cancer, RAS/BRAF Wild-type and Good Performance Status Phase 2
Active, not recruiting NCT01910610 - Multi-Line Therapy Trial in Unresectable Metastatic Colorectal Cancer Phase 3
Recruiting NCT05759728 - A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer Phase 1/Phase 2
Recruiting NCT04874207 - Evaluation of Treatment PERSOnalization Based on Its Therapeutic Monitoring in Patients With Metastatic Colorectal Cancer Treated With REgorafenib Phase 4