Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

All Drugs and Chemicals

Hematinics

Vaccines

Immunomodulating Agents

Liver Extracts

Intradermal injection (ID) of AlloStim(TM) (1ml) on day 4 and 7. AlloVax Treatment: ID injection of AlloSim(TM) (1 ml) followed immediately by the ID injection of CRCL (1ml) on day 11 and 14 in same location on the left arm and on day 18 and 21 in the same location on the right arm. Intravenous infusion of AlloStim(TM)(5ml) and a CRCL alone Intradermal injection on Day 27.

AlloVax

CRCL

AlloStim

Yaron Ilan, MD

The purpose of this study is to determine the safety and the immunological, radiological, and pathological response of the personalized anti-cancer vaccine AlloVax(TM) in patients with refractory Hepatocellular Carcinoma (HCC) and who are not eligible for any approved HCC treatments or have failed all approved HCC treatments. AlloVax(TM) is a personalized anti-cancer vaccine combining Chaperone Rich Cell Lysate (CRCL) as a source of tumor antigen prepared from patient's tumor and AlloStim(TM) as an adjuvant. The combination of these two components provides a vaccine designed to bring out an immune response capable of finding and killing the tumor cells.

All accrued subjects will undergo tumor harvest procedure. The tumor samples will be processed into personalized Chaperone Rich Cell Lysate (CRCL) vaccine. This study consists of three phases: priming phase, vaccination phase, and activation phase. The priming phase involves intradermal injections of AlloStim(TM). The aim of this phase is to increase the titer of Th1 immune cells in circulation. The vaccination phase involves the intradermal injections of AlloSim(TM) immediately followed by the intradermal injections of CRCL. This phase is designed to elicit tumor-specific immunity. The activation phase involves intravenous infusion of AlloStim(TM). This phase is designed to activate memory cells and NK cells and cause them to extravasate and traffic to tumor sites.

An Individualized Anti-Cancer Vaccine Study in Patients With HCC

An Individualized Anti-Cancer Vaccine (AlloVaxTM) Study in Patients With Refractory Hepatocellular Carcinoma (HCC)

To determine if there are any evidence of anti-tumor immune-mediated response by radiological and pathological changes.

To assess adverse events and laboratory abnormalities associated with AlloVax

Determine if AlloVax elicits detectable tumor specific immunity

Biomarker concentration will be evaluated at different time points.

Immunovative Therapies, Ltd.

Blood and Lymph Conditions

Immune System Diseases

Heart and Blood Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Hodgkin Disease

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Myeloid Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Graft Versus Host Disease

Lymphosarcoma

Chronic Lymphocytic Leukemia

Chronic Myeloid Leukemia

Hodgkin Lymphoma

Acute Graft Versus Host Disease

Intravenous AlloStim infusion on day 1 and day 7

Intravenous AlloStim infusion on day 1, day 7 and day 14

Intravenous AlloStim infusion on day 1, day 7, day 14 and day 21

single intravenous infusion of 1 x 10\^9 AlloStim cells

Intravenous infusion of 1 x 10\^9 AlloStim on day 1 and a second intravenous infusion of 1 x 10\^8 AlloStim on day 7

Intravenous infusion of 1 x 10\^9 AlloStim on day 1 and a second intravenous infusion of 1 x 10\^8 AlloStim on day 7 and day 14

Intravenous infusion of 1 x 10\^9 AlloStim on day 1 and a second intravenous infusion of 1 x 10\^8 AlloStim on day 7, day 14 and day 21

Dr. Michael Har-Noy

The purpose of this study is to determine the safety and anti-tumor effects of an experimental immunotherapy drug, called AlloStim, which is intentionally mis-matched immune cells which are designed to elicit the same anti-tumor mechanism that occurs in allogeneic bone marrow/stem cell mini-transplant (BMT) procedures, without the toxicity associated with graft vs. host disease (GVHD).

AlloStim is combination biological drug and medical device formulation consisting of allogeneic immune cells that have been expanded and differentiated ex-vivo. These cells are conjugated to monoclonal antibody coated microparticles prior to infusion. The immune cells are living CD4+ memory Th1-like T-cells (T-Stim) that are differentiated from precursors purified from normal donor blood. AlloStim is a composition of T-Stim cells conjugated to paramagnetic epoxy covered microparticles (4.5micron) with covalently bound anti-CD3/anti-CD28 monoclonal antibodies (Dynabeads® ClinExVivo™ CD3/CD28) at a 2:1 bead:cell ratio. The T-Stim cells are intentionally mismatched to the recipient.

The graft vs. tumor (GVT) effect that occurs after allogeneic bone marrow transplant (BMT) is a curative therapy for advanced hematological malignancy but the clinical application of GVT is severely limited by graft vs. host disease (GVHD) toxicity. AlloStim is designed to elicit the "mirror" of the GVT/GVHD effects in the host immune system. Rather than trying to separate these effects, we have proposed that the effects could remain associated and "mirrored" onto the host immune system creating linked host vs. tumor (HVT) and host vs. graft (HVG) effects. We hypothesized that allogeneic Th1 memory cells activated at time of infusion to produce type 1 cytokines and express CD40L would elicit HVT/HVG "mirror effects" in immunocompetent cancer patients.

A Phase I/II Study of Mis-Matched Immune Cells (AlloStim) in Patients With Advanced Hematological Malignancy

A Phase I/II Study of Intentionally Mis-Matched, Allogeneic Th1 Memory Cells (AlloStim) Conjugated With CD3/CD28-coated Microbeads in Patients With Relapsed or Refractory Hematological Malignancy

Hadassah Medical Organization

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Prostatic Neoplasms

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Sarcoma

Melanoma

Carcinoma, Renal Cell

Colorectal Neoplasms

Skin Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Connective and Soft Tissue

Ovarian Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Neuroendocrine Tumor

Neuroepithelioma

Anti-Infective Agents

Central Nervous System Depressants

Ethanol

Patients meeting eligibility criteria will be primed with at least three and up to nine intradermal AlloStim-TM injections at a frequency of every 2-8 days at doses between 1-4 x 10\^7 cells

Percutaneous cryoablation of selected tumor lesion under CT or US guidance

Cryoablation

intratumoral injection of AlloStim-TM into cryoablated tumor lesion at a dose of 1-6 x 10\^7 cells

intravenous AlloStim-TM at doses between 1 x 10\^7 to 1 x 10\^9 cells

Intraperitoneal AlloStim-TM infusion in patients with peritoneal carcinomatosis and/or ascites

Patients with malignant pleural effusion may receive intrapleural AlloStim-TM infusion at a dose of 5-10 x 10\^7 cells.

Patients with palpable tumors may receive alcohol ablation and intratumoral AlloStim-TM

Tamar Peretz, MD

A Phase I/II study of an in-situ therapeutic cancer vaccine. Vaccines contain a source of antigen and and adjuvant. In this study the source of tumor antigen comes from the killing of a selected tumor by cryoablation (killing using extreme cold) and the adjuvant is intentionally mis-matched immune cells (AlloStim-TM) engineered to produce inflammatory cytokines.

This is a Phase I/II clinical study to investigate the optimal protocol and indication for creating a personalized anti-tumor vaccine within the body of patients with cancer. The aim of the study is to evaluate the safety of administration and anti-tumor effect of a vaccine protocol that has three separate steps. Cancer patients generally present with an immune response to cancer biased to a Th2 response, while a Th1 response is considered necessary for mediating anti-tumor immunity. The first step of the study consists of multiple intradermal priming doses of AlloStimTM. The aim of this step is to create Th1 immunity to the alloantigens in AlloStimTM, thus increasing the number of Th1 cells in circulation. The second step of the protocol involves the cryoablation of a selected tumor lesion followed by an intratumoral AlloStimTM injection. The aim of this step is to generate tumor-specific CTL killer cells in the circulation. The final step is an intravenous infusion of AlloStimTM. The aim of this step is to activate circulating Th1 cells, killer cells, and natural killer cells. The further aim of this step is to create an inflammatory environment that can break-down the ability of the tumor to avoid an anti-tumor immune response. In patients with partial responses and recurrence of disease, additional intravenous "booster" infusions are utilized to reactivate the circulating immune cells.

Experimental Therapeutic Cancer Vaccine Created In-situ in Patients With Stage II-Stage IV Cancer

A Phase I/II Study of an Experimental Therapeutic Cancer Vaccine Created In-situ in Patients With Stage II-Stage IV Cancers

Michael Har-Noy

Investigator: Dept of Bone Marrow Transplantation and Immunotherapy

AlloStim is administered in three cycles:

Cycle 1 Day 0: 0.5ml ID AlloStim® Day 7: 0.5ml ID AlloStim® Day 14: 0.5ml ID AlloStim® Day 21: 0.5ml ID AlloStim® Day 28: 0.5ml ID AlloStim®

Cycle 2 Day 42: 0.5ml ID AlloStim® Day 49: 0.5ml ID AlloStim® Day 56: 0.5ml ID AlloStim® Day 63: 0.5ml ID AlloStim® Day 70: 0.5ml ID AlloStim® + 3ml IV AlloStim®

Cycle 3 Day 84: 0.5ml ID AlloStim® Day 91: 0.5ml ID AlloStim® Day 98: 0.5ml ID AlloStim® Day 105: 0.5ml ID AlloStim® Day 112: 0.5ml ID AlloStim® + 3ml IV AlloStim®

Living bioengineered, non-genetically manipulated, activated Th1-like immune cells differentiated and expanded from precursor cells purified from blood of healthy unrelated donors

Kim Demonte

Thu Bui, MHA

Luz Smith

Mike Cusnir, MD

Oleg Gligich, MD

Gerard Chaaya, MD

Jacqueline Barrientos, MD

Ragisha Gopalakrishnan, MD

Aron Simkins, MD

Michael Schwartz, MD

Prachi Shah

Paige Buzenski

Mohammed Al Hallak, MD

Michelle Mackenzie, RN

David Gallinson, MD

Karla Witkowski

Azriel Hirschfeld, MD

This is a Phase IIB multi-site, open label study of a next generation immunotherapy for third-line MSI-S metastatic colorectal cancer using an "off-the-shelf", non-genetically manipulated living immune cell product (AlloStim) derived from the blood of healthy donors.

This is a Phase IIB open label immunotherapy protocol called "StimVax". The protocol design is based upon information obtained from a previous Phase IIA dose level and dose frequency ranging study. The population targeted is MSI-S metastatic colorectal cancer previously treated with two lines of chemotherapy regimens, one containing oxaliplatin and the other containing irinotecan. This population is not considered to be responsive to immunotherapy.

The study drug is called "AlloStim". AlloStim is an "off-the-shelf", non-genetically-manipulated, living immune cell immunotherapy. AlloStim is derived from precursors purified from the blood of healthy donors and grown and differentiated in specialized bioreactors in the laboratory. Because the donors are intentionally mis-matched to the host, AlloStim is completely eliminated by the host in a non-toxic rejection response within 24h of administration.

Unlike autologous immune cell therapies, like CAR-T cells or TIL cells, AlloStim is allogeneic and is not intended to directly kill tumors. Rather, the novel AlloStim mechanism is designed to modify and train the host immune system to kill tumors and prevent tumor growth and spread. Uniquely, the AlloStim mechanism is also designed to increase Th1/Th2 balance, activate innate effector cells (such as NK and NKT), counter-regulate the immune suppressive and immune evasion mechanisms that tumors use to evade immune elimination both systemically and in the tumor microenvironment.

The AlloStim mechanism creates self-amplifying waves of temporal and spatial immune effects that can lead to an initial non-specific cellular innate NK cell immune response followed by a tumor-specific killer T-cell immune response specific for the host tumor through a combination of immune processes called "allo-priming" and "in-situ vaccination".

Immunotherapy for Third Line Metastatic Colorectal Cancer

Phase IIB Open-Label Study to Assess the Safety and Efficacy of STIMVAX® as Third-line Therapy for Metastatic Colorectal Cancer

measurement of the survival on experimental treatment

Mirror Biologics, Inc.

Breast Diseases

Antineoplastic Agents

Capecitabine

Taxane

Immunologic Factors

1. the priming step with ID injection of AlloStim on Days 0, 7, and 14;
2. the ablation step with cryoablation and intra-tumor injection of AlloStim on Day 21;
3. the activation step with an IV infusion of AlloStim on Day 28;
4. the booster step with intravenous booster infusion of AlloStim on Days 56 and 84;

Protocol follow-up procedures continue until day 168 and at investigator discretion thereafter.

1. the priming step with ID injection of AlloStim on Days 0 and 3 and an additional ID injection of AlloStim on Days 7 and 10;
2. the ablation step with cryoablation and intra-tumor injection of AlloStim on Day 14;
3. the activation step with an IV infusion of AlloStim on Day 21;
4. the booster step with intravenous booster infusion of AlloStim on Days 49 and 77.

Protocol follow-up procedures continue until day 168 and at investigator discretion thereafter.

1. the priming step with ID injection of AlloStim on Days 0 and 3 and an additional ID injection of AlloStim on Days 7 and 10;
2. the ablation step with cryoablation and intra-tumor injection of AlloStim on Day 14, and intra-tumor injection of AlloStim again into the same cryoablated lesion on Day 17;
3. the activation step with an IV infusion of AlloStim on Day 21;
4. the booster step with intravenous infusion of AlloStim on days 49 and 77.

Protocol follow-up procedures continue until day 168 and at investigator discretion thereafter.

AlloStim is derived from the blood of normal blood donors and is intentionally mismatched to the recipient.

Percutaneous ablation of a single metastatic tumor lesion usually in liver or bone. The procedure is conducted under CT or ultrasound image-guidance.

Zivile Katiliene, Ph.D.

This phase I/II study is designed to compare different treatment schedules of a personalized anti-cancer vaccine protocol which combines the cryoablation of a selected metastatic lesion with intra-tumor immunotherapy. The cryoablation causes the tumor to release tumor-specific antigens into the surrounding environment. The injection of bioengineered allogeneic immune cells, AlloStim(TM), into the lesion is designed to modulate the immune response and educate the immune system to kill other tumor cells.

The study will assess three different dosing schedules. A standard 3 plus 3 study design will be used. The starting dose for each dosing schedule will be escalated in subsequent groups of patients. The study will evaluate safety of increased frequency of AlloStim (TM) dosing and anti-tumor effect of the new proposed dose and frequency schedule.

Increased Frequency of AlloStim(TM) Dosing in Combination With Cryoablation in Metastatic Breast Cancer Patients

In-Situ Cancer Vaccine: Phase I/IIb, Open-Label Study to Assess Safety of AllostimTM in Combination With Cryoablation in Metastatic Breast Cancer Previously Treated With an Anthracycline, a Taxane and Capecitabine

Blood samples will be evaluated for immunological response and a determination made as to whether immunological response correlates with RECIST and pathology.

The changes in tumor burden by RECIST and compare these changes with the pathological analysis of corresponding biopsies.

Three patients are enrolled at each frequency schedule in the absence of dose limiting toxicity (DLT). A DLT is defined as any allergic or autoimmune toxicity or other study drug related toxicity Grade 3 or higher during the DLT assessment window.

Health-Related Quality of life will be measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and its supplementary breast cancer questionnaire (QLQ-BR23).

Each treatment schedule will be monitored for radiological, pathological, and immunological response. These assessments will be compared between three treatment schedules.

Neoplasm Metastasis

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Individualized Anti-Cancer Vaccine Study in Patients With HCC	NCT01995227	Hepatocellular ...	AlloVax CRCL AlloStim	18 Years -	Immunovative Therapies, Ltd.
A Phase I/II Study of Mis-Matched Immune Cells (AlloStim) in Patients With Advanced Hematological Malignancy	NCT00558675	Hematological M... Leukemia Lymphoma Multiple Myelom...	AlloStim AlloStim AlloStim AlloStim	18 Years -	Immunovative Therapies, Ltd.
Experimental Therapeutic Cancer Vaccine Created In-situ in Patients With Stage II-Stage IV Cancer	NCT01065441	Solid Tumors St... Breast Cancer Colorectal Canc... Prostate Cancer Melanoma Ovarian Cancer Sarcoma Non-small Cell ...	AlloStim Cryoablation AlloStim AlloStim AlloStim AlloStim AlloStim	18 Years -	Immunovative Therapies, Ltd.
Immunotherapy for Third Line Metastatic Colorectal Cancer	NCT04444622	Metastatic Colo...	AlloStim	18 Years -	Immunovative Therapies, Ltd.
Increased Frequency of AlloStim(TM) Dosing in Combination With Cryoablation in Metastatic Breast Cancer Patients	NCT02018419	Metastatic Brea...	AlloStim Cryoablation	18 Years - 70 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.
Safety and Tolerability Study of AlloVax(TM) in Patients With Metastatic or Recurrent Cancer of the Head and Neck	NCT01998542	Cancer of Head ... Squamous Cell C...	AlloVax CRCL AlloStim	18 Years - 70 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.
A Phase I/II Study of Mis-Matched Immune Cells (AlloStim) in Patients With Advanced Hematological Malignancy	NCT00558675	Hematological M... Leukemia Lymphoma Multiple Myelom...	AlloStim AlloStim AlloStim AlloStim	18 Years -	Immunovative Therapies, Ltd.
Safety and Tolerability Study of AlloVax(TM) in Patients With Metastatic or Recurrent Cancer of the Head and Neck	NCT01998542	Cancer of Head ... Squamous Cell C...	AlloVax CRCL AlloStim	18 Years - 70 Years	Immunovative Therapies, Ltd.

Spots Global Cancer Trial Database for allostim

Every month we try and update this database with for allostim 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 allostim

Every month we try and update this database with for allostim 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 allostim 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.