Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

All Drugs and Chemicals

Hematinics

Anti-Infective Agents

Antineoplastic Agents

Vaccines

Immunomodulating Agents

Liver Extracts

Interferons

Interferon-gamma

* The priming step with ID injections of AlloStim on Days 0, 7, and 14
* The vaccination step with cryoablation and IT (intratumoral) injection of AlloStim on Day 21
* The activation step with IV infusion of AlloStim on Day 28
* The booster step with two IV booster infusions of AlloStim on Days 56 and 84

Protocol follow-up procedures continue until day 112. Efficacy evaluation will continue monthly for each subject until death or loss to follow-up

* The priming step with ID injections of AlloStim on Days 0, 3 and days 7 and 10
* The vaccination step with cryoablation and IT (intratumoral) injection of AlloStim on Day 14
* The activation step with IV infusion of AlloStim on Day 21
* The booster step with two IV booster infusions of AlloStim on Days 49 and 77

Protocol follow-up procedures continue until day 105. Efficacy evaluation will continue monthly for each subject until death or loss to follow-up

* The priming step with ID injections of AlloStim on Days 0, 3, 7, 10 and day 14
* IV AlloStim on Day 21
* The booster step with two IV booster infusions of AlloStim on Days 49 and 77

Protocol follow-up procedures continue until day 105. Efficacy evaluation will continue monthly for each subject until death or loss to follow-up

The priming step with ID injections of AlloStim on Days 0, 3, 7, 10 and day 14

* IV AlloStim on Day 21
* The booster step with two IV booster infusions of AlloStim on Days 49 and 77

Protocol follow-up procedures continue until day 105. Efficacy evaluation will continue monthly for each subject until death or loss to follow-up Protocol follow-up procedures continue until day 105. Efficacy evaluation will continue monthly for each subject until death or loss to follow-up

AlloStim is an activated living CD4+ Th1 memory cell derived from the blood of normal blood donors and intentionally mismatched to the recipient. AlloStim is bioengineered to express high levels of Type 1 inflammatory cytokines (such as interferon-gamma, TNF-alpha, GM-CSF) and immunomodulatory molecules such as CD40L. AlloStim has CD3/CD28-coated microbeads attached to assure activation upon infusion.

AlloStim

Percutaneous partial cryoablation of a single metastatic tumor lesion in the liver. The procedure is conducted under CT or ultrasound image-guidance

Cryoablation

Madappa Kundranda, MD PHD

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.

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.

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

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

Longitudinal changes in tumor burden by RECIST and compare these changes with the histopathological analysis of corresponding biopsies

To assess whether immune response correlates with Overall Survival (OS), RECIST and histopathology

Three patients are enrolled at each frequency schedule in the absence of dose limiting toxicity (DLT).Two types of toxicity are assessed for determination of whether a Dose Limiting Toxicity (DLT) has occurred. An acute dose limiting toxicity (ADLT) is assessed within 48h of a dose administration. Cumulative dose limiting toxicity (CDLT) is assessed during the complete Safety Evaluation Period.

Subjects at the new proposed dose and frequency schedule will be monitored for radiological, pathological and immunological response

Health-Related Quality of Life (HRQoL) will be measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)

Immunovative Therapies, Ltd.

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Everolimus

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Retaspimycin HCl (IPI-504) and everolimus will be administered on a 21-day cycle. All patients will remain on study until progression of disease or intolerability to study treatments occurs.

IPI-504

Tess Schmalbach, MD, PhD

Study IPI-504-15 is a Phase 1b/2 clinical trial to evaluate the safety and efficacy of retaspimycin HCl (IPI-504) plus everolimus in patients with KRAS mutant Non-small Cell Lung Cancer (NSCLC).

This is a Phase Ib/2 study of retaspimycin HCl (IPI-504) in combination with everolimus. The Phase 1b portion is to test the safety and tolerability of retaspimycin HCl (IPI-504) in combination with everolimus and determine the highest dose of retaspimycin HCl (IPI-504) and everolimus that can safely be given in combination. The Phase 2 portion of this study will continue the evaluation of safety of retaspimycin HCl (IPI-504) in combination with everolimus and compare the effect of the study drugs on tumor response and life expectancy in patients with KRAS mutant NSCLC.

Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in KRAS Mutant Non-small Cell Lung Cancer

A Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in Patients With KRAS Mutant NSCLC

Overall response rate (ORR), defined as a partial response (PR) or complete response (CR) occurring at any point post-treatment according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

Progression free survival (PFS), defined as time from study entry to progression or death whichever occurs first.

Time to progression (TTP), defined as time from study entry to progression.

Overall survival (OS), defined as time from study entry to death due to any cause, in patients with KRAS mutant NSCLC administered IPI-504 plus everolimus.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
AlloStim® Immunotherapy Dosing Alone or in Combination With Cryoablation in Metastatic Colorectal Cancer	NCT02380443	Colorectal Canc...	AlloStim Cryoablation	18 Years - 80 Years	Immunovative Therapies, Ltd.
AlloStim® Immunotherapy Dosing Alone or in Combination With Cryoablation in Metastatic Colorectal Cancer	NCT02380443	Colorectal Canc...	AlloStim Cryoablation	18 Years - 80 Years	Immunovative Therapies, Ltd.
Phase 1b/2 Study of Retaspimycin HCl (IPI-504) in Combination With Everolimus in KRAS Mutant Non-small Cell Lung Cancer	NCT01427946	Non-small Cell ...	IPI-504 Everolimus	18 Years -	Infinity Pharmaceuticals, Inc.

Spots Global Cancer Trial Database for kras mutant

Every month we try and update this database with for kras mutant cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for kras mutant

Every month we try and update this database with for kras mutant cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for kras mutant cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.