AlloStim® In-Situ Vaccine in Pre-Treated Metastatic Colorectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01741038|
Recruitment Status : Not yet recruiting
First Posted : December 4, 2012
Last Update Posted : August 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Biological: AlloStim® Procedure: cryoablation Other: Physician's Choice (PC)||Phase 2 Phase 3|
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 due to a mutation in KRAS or BRAF.
This is a Phase II/III, randomized, open-label, multicenter, controlled, two arm study designed to determine the efficacy in terms of OS and the safety of the InSituVax (AlloStim+ Cryoablation) personalized in-situ anti-cancer vaccine protocol (Treatment Arm) compared with Physician's Choice (PC) of Treatment + Cryoablation (Control Arm) in Metastatic Colorectal Cancer. Subjects are randomized 2:1 into the treatment or control arms.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II/III, Randomized, Open Label, Controlled, Two Arm Study Comparing Overall Survival of AlloStim® Combined With Cryoablation to a Physician's Choice Combined With Cryoablation in 3rd Line Treatment for Metastatic Colorectal Cancer|
|Study Start Date :||December 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||October 2020|
Experimental: AlloStim® treatment
The treatment schedule includes: (1) the priming step with two ID AlloStim® injections (Days 0 and 3), an additional two ID injections followed by IV infusion of AlloStim® (Days 7 and 10); (2) the vaccination step with cryoablation of a single metastatic lesion followed by injection of AlloStim® into the ablated tumor and IV infusion of AlloStim® on protocol day 14, followed by IV infusion of AlloStim® on Day 17 (3) the activation step with an IV study drug infusion on Day 21 and (4) the booster step with IV booster infusions of AlloStim® on days 49 and 77. Additional booster infusions can be administered monthly at the discretion of the Investigator.
AlloStim® is derived from the blood of normal blood donors and is intentionally mismatched to the recipient. CD4+ T-cells are separated from the blood and differentiated and expanded for 9-days in culture to make an intermediary called T-Stim. AlloStim is made by incubating T-Stim cells for 4h with antibody coated microbeads. The cells with the beads still attached are suspended in infusion media and loaded into syringes. The syringes are shipped refrigerated to the point-of-care.Procedure: cryoablation
percutaneous ablation of a single metastatic tumor lesion usually in liver. The procedure is conducted under CT or ultrasound image-guidance.
Physician's Choice (PC)
All subjects will be assigned Physician's Choice (PC) therapy. PC can consist of best supportive care (BSC) or any US-FDA-approved cancer drug (e.g. Cetuximab) administrated as a monotherapy at the manufacturer's recommended dose. The treatment schedule shall be prospectively determined and administered as tolerated.
percutaneous ablation of a single metastatic tumor lesion usually in liver. The procedure is conducted under CT or ultrasound image-guidance.Other: Physician's Choice (PC)
Physician's Choice therapy can consist of best supportive care (BSC) or any US-FDA approved cancer drug (e.g. Cetuximab) administrated as a monotherapy at the manufacturer's recommended dose. The treatment schedule shall be prospectively determined and administered as tolerated
- Overall Survival [ Time Frame: from randomization within 30 days of accrual to death for any cause followed for up to 2 years from date of randomization ]To assess whether cryoablation combined with AlloStim treatment (arm 1) provides an overall survival (OS) advantage when compared to treatment with cryoablation combined with physician's choice (arm 2).
- Safety [ Time Frame: 168 days from randomization ]Safety will be evaluated by physical exam, changes in laboratory values and patient reported symptoms
- Health-Related Quality of Life (HRQoL) [ Time Frame: 168 days from randomization ]To assess change in HRQoL between treatment arms
- Immunological Response [ Time Frame: 168 days from randomization ]blood samples will be evaluated for immunological response and a determination made as to whether immunological response correlates with survival
- Longitudinal changes in tumor burden [ Time Frame: 168 days from randomization ]To document the longitudinal changes in tumor burden by Response Evaluation Criteria in Solid Tumors (RECIST) and Immune-Related Response Criteria (irRC)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741038
|Contact: Thu Bui, BSfirstname.lastname@example.org|
|National Cancer Institute of Thailand||Not yet recruiting|
|Contact: Supranee Kongpinyopanich, MS +66-2-354-3273 email@example.com|
|Principal Investigator: Wirote Lausoontornsiri, MD|
|Principal Investigator:||Wirote Lausoontornsiri, MD||National Cancer Institute of Thailand|
|Study Director:||Thu Bui, BS||Immunovative Therapies, Ltd.|