All Drugs and Chemicals

Vaccines

Monatide (IMS 3015)

Adjuvants, Immunologic

Immunologic Factors

NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51 was administered to patients with cancer expressing NY-ESO-1 or LAGE-1 antigen. The injections were given subcutaneously beginning on week 1 and repeated every three weeks for 4 injections total. There was a 3 week follow-up period after the last injection. In the absence of toxicity and progressive disease (PD), a second cycle was offered to patients who received 4 vaccinations.

NY-ESO-1b peptide plus CpG 7909 and Montanide® ISA-51

Nasser K Altorki, MD

This cancer vaccine research study involves the injection of the NY-ESO-1b peptide along with 2 other agents to help stimulate the immune system. Peptides are small fragments of protein. NY- ESO-1 peptides are normally found in the testis and the placenta. They have also been found on various types of cancer cells. The purpose is to stimulate the immune system to react against the peptides that are found on cancer cells.

This is a pilot study of patients of HLA-A2 phenotype whose tumor expresses the NY-ESO-1 or LAGE-1 antigen. Patients will receive NY-ESO-1b peptide mixed with 0.5 milliliter (mL) of Montanide® ISA-51 and 1 mg of CpG 7909 given every three weeks for four doses by subcutaneous injection. There will be a three-week follow-up period after the fourth injection making the cycle 13 weeks long. In the absence of toxicity and progressive disease, a second cycle will be offered to patients who have received four vaccinations.

The primary objective is to evaluate the immune response (antibodies, CD8+ T-cells, and DTH) and safety to vaccination with NY-ESO-1b peptide mixed with CpG 7909 and Montanide® in patients with cancer expressing NY-ESO-1 or LAGE-1. The secondary objective is to document tumor responses in patients with evaluable or measurable disease.

A Pilot Study of NY-ESO-1b Peptide Plus CpG 7909 and Montanide® ISA-51 in Patients With Cancer.

A Pilot Study of NY-ESO-1b Peptide Plus CpG 7909 and Montanide® ISA-51 in Patients With Cancer Expressing NY-ESO-1 or LAGE-1.

Blood samples were obtained at baseline (prior to the first dose), prior to the second, third and fourth injection and 2 weeks after the fourth injection in both cycles 1 and 2 for the assessment of NY-ESO-1 specific antibodies by an enzyme-linked immunosorbent assay (ELISA). A positive response was a readable optical density at 280 nm.

Blood samples were obtained at baseline, prior to the second, third and fourth injection and 2 weeks after the fourth injection in both cycles 1 and 2 for the assessment of NY-ESO-1b specific CD8+ T-cells by ELISPOT assays.

10 mcg NY-ESO-1b peptide was injected intradermally at a separate site from the vaccination at baseline and after the second and fourth injection of each cycle.

Assessment of DTH reactions as evidenced by redness and induration was performed 48 h after injection.

The number of patients with DTH positive skin reactions was reported at each timepoint.

DLT was defined as the following toxicities definitely, probably, or possibly related to the administration of NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51:

* ≥ Grade 2 autoimmune phenomena
* Asymptomatic bronchospasm or generalized urticaria
* ≥ Grade 3 hematological and non hematological toxicities.

Computed tomography (CT) scans were performed at screening, and during weeks 13 and 28. Response was assessed using RECIST version 1.0 (Therasse et al, J Natl Cancer Inst 2000; 92:205-16). Per RECIST, target lesions are categorized as follows: complete response (CR): disappearance of all target lesions (no evaluable disease); partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria. No evidence of disease (NED): no target or non-target lesions at baseline and no new lesions identified on post-baseline scans.

Ludwig Institute for Cancer Research

All adverse events (AEs) occurring after signed informed consent were to be documented in the source records and on the respective AE case report form (CRF), regardless of causal relationship. Toxicity was evaluated according to the National Cancer Institute CTCAE Scale (Version 3.0).

NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51 was administered to patients with cancer expressing NY-ESO-1 or LAGE-1 antigen. The injections were given subcutaneously beginning on week 1 and repeated every three weeks for 4 injections total. There was a 3 week follow-up period after the last injection of peptide. In the absence of toxicity and PD, a second cycle was offered to patients who received 4 vaccinations.

Patients With Cancer Expressing NY-ESO-1 or LAGE-1 Antigen.

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Germany

United States

Region of Enrollment

Jonathan Skipper PhD

Number of patients with negative titers both pre- and post-treatment

Number of patients with positive titers both pre- and post-treatment

Number of patients with negative titers at baseline and positive titers after treatment

NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51 was administered to patients with cancer expressing NY-ESO-1 or LAGE-1 antigen. The injections were given subcutaneously beginning on week 1 and repeated every three weeks for 4 injections total. There was a 3 week follow-up period after the last injection. In the absence of toxicity and PD, a second cycle was offered to patients who received 4 vaccinations.

All patients who received at least one dose of NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51 and had pre- and post-treatment samples taken.

Number of Patients With NY-ESO-1 Specific Humoral Immunity as Determined by an Increase in Antibody Titer From Baseline.

Number of patients with an increase in NY-ESO-1b specific CD8+ T-cells during cycle 1

Number of patients without an increase in NY-ESO-1b specific CD8+ T-cells during cycle 1

Number of patients with an increase in NY-ESO-1b specific CD8+ T-cells during cycle 2

All patients who received at least one dose of NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51 and had pre- and post-treatment samples taken were included in the Cycle 1 results. Cycle 2 results include all patients who received Cycle 2 treatment.

Number of Patients With NY-ESO-1 Specific Cellular Immunity as Measured by an Increase in NY-ESO-1b Specific CD8+ T-cells Following Treatment.

Baseline

Week 4

Week 10

Week 19

Week 25

All patients who received at least one dose of NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51 and had pre- and post-treatment assessments at the given timeframes. One patient did not have post-injection DTH testing.

Number of Patients With Delayed-Type Hypersensitivity (DTH) Skin Reactions to NY-ESO-1b Peptide

NY-ESO-1b peptide, 100 μg mixed with 1mg CpG 7909 and 0.5mL of Montanide® ISA-51 was administered to patients with cancer expressing NY-ESO-1 or LAGE-1 antigen. The injections were given subcutaneously beginning on week 1 and repeated every three weeks for 4 injections total. There was a 3 week follow-up period after the last injection. In the absence of toxicity and PD, a second cycle was offered to patients who received 4 vaccinations.

All patients who received at least one dose of NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51.

Safety as Measured by the Number of Patients With Dose Limiting Toxicities (DLT)

Stable Disease

Complete Response

Partial Response

No Evidence of Disease

Progressive Disease

All patients who received at least one dose of NY-ESO-1b peptide, 100 μg mixed with 1 mg CpG 7909 and 0.5mL of Montanide® ISA-51 and had at least one tumor response assessment.

Number of Patients With Tumor Responses as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)

Overall Study

Symptoms and General Pathology

All Conditions

Infections

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Recurrence

Mycoses

Mycosis Fungoides

Bacterial Infections

Communicable Diseases

Bacterial Infections and Mycoses

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Cutaneous

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

CPG 7909

Ronald Levy

This is a single institution phase I / II trial to evaluate the safety and efficacy of intratumoral CpG injections combined with local radiation in patients with mycosis fungoides. Patients will receive low-dose radiotherapy to a single tumor site on days 1 and 2 (2 Gy each day). CpG injections will be administered into the same tumor site within 24 hours before or 24 hours after each radiation treatment. Weekly doses of (intratumoral or peritumoral injections) CpG will be then administered subcutaneously in the region of previous injections for 23 additional doses. The total treatment duration is 24 weeks.

Phase I/II Study of Intratumoral Injection of CPG 7909, a TLR9 Agonist, Combined With Local Radiation for Patients With Recurrent Mycosis Fungoides.

Phase I/II Study of Intratumoral Injection of CPG 7909, A TLR9 Agonist, Combined With Local Radiation for Patients With Recurrent Mycosis Fungoides

National Institutes of Health (NIH)

Stanford University

Robert K. and Helen K. Summy Professor in the School of Medicine

Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)

Mycosis fungoides patients must have failed or have been intolerant of at least 1 topical or 1 systemic treatment

Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)

6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).

This is a single institution phase 1-2 trial to evaluate the safety, feasibility and efficacy of CpG injections (4 intratumoral injections followed by 6 peri-tumoral injections) combined with local irradiation in patients with recurrent low-grade lymphomas.

Patients will receive low-dose radiotherapy to a single tumor site on days 1 and 2 (2 Gy each day). CpG injections will be administered into the same tumor site within the 24 hours before and the 24 hours after the radiation, and on days 8 and 15. Weekly doses of CpG will be then administered subcutaneously in the region of previous injections for 6 additional doses.

CPG 7909 + Local Radiotherapy in Recurrent Low-Grade Lymphomas

Le23 CPG: A Phase 1-2 Study of Intratumoral Injection of CPG 7909, A TLR 9 Agonist, Combined With Local Radiation in Recurrent Low-Grade Lymphomas

Objective Response Rate (ORR) consisting of Complete Response (CR) + Partial Response (PR), not including Stable Disease (SD)

Lymphoma Research Foundation

American Society of Clinical Oncology

Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)

CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).

Lymphoma, B-cell Low-grade (BCL)

Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)

CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections).

Mycosis Fungoides (MF)

Total

Age, Continuous

Ronald Levy, MD / Robert K and Helen K Summy Professor of Medicine

Objective Response Rate (ORR)

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Intravenous infusions will be administered with a standard infusion pump beginning at 125 cc/hr through an intravenous catheter (central or peripheral).

Subcutaneous injections should be administered in the abdominal wall, upper arm, hip, or anterior thigh. If the volume of injection exceeds 1.5 ml, the volume should be divided into equal injections at a volume less than 1.5 ml and administered in different areas of the body. The maximum dose level on this trial may require 5 - 6 injections at an equal number of sites.

CpG 7909

Brian Link, MD

Clive Zent, M.D.

* CpG has the potential to stimulate the immune system
* this study will evaluate the safety of CpG given sub-q or IV
* purpose is to measure biological changes in CLL cells after receiving CpG

A Dose Finding Study of CpG in Patients With Chronic Lymphocytic Leukemia Who Have Been Previously Treated

A Dose-Finding Study of CpG 7909 in Previously Treated Chronic Lymphocytic Leukemia

Mayo Clinic

Pfizer

National Cancer Institute (NCI)

University of Iowa

Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Immunomodulating Agents

In the phase I portion of the protocol, patients will be included in escalating dose groups: 0.08, 0.12, 0.16, 0.36, 0.54 or 0.81 mg/kg of CPG 7909 Injection. Patients will be treated once weekly subcutaneously for 24 weeks. In the Phase II portion of the trial patients will be treated at the MTD or the highest dose of 0.81 mg/kg identified in the Phase I dose escalation portion of the trial. All patients in Phase I and Phase II will be treated until disease progression or a maximum of 24 weeks.

Pfizer CT.gov Call Center

CPG 7909 given alone to patients with renal cell cancer after their nephrectomy. CPG 7909 is as a subcutaneous injection once per week for up to 24 weeks. Up to 40 patients will be included in the study.

CPG 7909 in Patients Wih Stage IV Renal Cell Cancer

A Phase I/II, Open Label, Multi-Center Study For The Evaluation Of CPG 7909 In Patients With Stage Iv Renal Cell Carcinoma

Director, Clinical Trial Disclosure Group

Skin and Connective Tissue Diseases

Breast Neoplasms

Antineoplastic Agents

Trastuzumab

Antineoplastic Agents, Immunological

Each 0.01 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.

Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert

Herceptin®

Each 0.04 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.

Each 0.16 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.

Each 0.32 mg/kg CPG 7909 treatment will consist of a monitored 2-hour infusion given once weekly until disease progression or a maximum of 24 weeks.

Harold Burstein, M.D., Ph.D.

The purpose of this study is to determine if the combination of CPG 7909 and Herceptin is safe and effective in the treatment of metastatic breast cancer.

RATIONALE: There is preclinical data that supports the hypothesis that CPG 7909 may potentiate the action of Herceptin. This Phase I/II study is designed to evaluate the safety and efficacy of the combination treatment of CPG 7909 and Herceptin in patients with metastatic breast cancer who have previously been treated with Herceptin and chemotherapy.

SCHEDULE: Patients will receive CPG 7909 weekly for up to six months.

Phase II part of study not initiated because the development plan modified the route of administration to subcutaneous injection.

Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer

A Phase I/II Open Label, Multi-Center Study For The Evaluation Of The Combination Of CpG 7909 And Herceptin® In Patients With Metastatic Breast Cancer

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Paclitaxel

Carboplatin

Docetaxel

Albumin-Bound Paclitaxel

Cisplatin

Taxane

Tubulin Modulators

Antimitotic Agents

Chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection

Chemotherapy (a taxane and a platinum compound)

CPG 7909 Injection will be administered subcutaneously at a starting dose of 0.20 mg/kg at the beginning of Weeks 2 and 3 of the three-week cycle.

A taxane and a platinum compound given on week one of three-week cycles:

Regimen A: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Cisplatin 75 mg/m2 Regimen B: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Carboplatin AUC of 6 Regimen C: Docetaxel 75 mg/m2, Cisplatin 75 mg/m2 Regimen D: Docetaxel 75 mg/m2, Carboplatin AUC of 6

Chemotherapy

Eligible patients will be randomized in a ratio of 2:1 to receive either chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection or chemotherapy alone. Protocol therapy will be administered until disease progression or intolerable toxicity. CpG 7909 Injection will be administered subcutaneously, on Weeks 2 and 3 of each three-week cycle (days 8 and 15) and chemotherapy will be administered on Week 1 (Day 1). Patients will undergo complete disease evaluation at the end of every other treatment cycle until disease progression.

CPG 7909 Injection in Non-Small Cell Lung Cancer

Promune™ (CPG 7909 Injection) In Combination With Chemotherapy In Patients With Advanced Or Metastatic Non-Small Cell Lung Cancer, A Randomized, Multi-Center, Controlled, Phase 2 Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Pilot Study of NY-ESO-1b Peptide Plus CpG 7909 and Montanide® ISA-51 in Patients With Cancer.	NCT00199836	Cancer Neoplasm	NY-ESO-1b pepti...	18 Years -	Ludwig Institute for Cancer Research
Phase I/II Study of Intratumoral Injection of CPG 7909, a TLR9 Agonist, Combined With Local Radiation for Patients With Recurrent Mycosis Fungoides.	NCT00226993	Mycosis Fungoid...	CPG 7909	18 Years -	Stanford University
Phase I/II Study of Intratumoral Injection of CPG 7909, a TLR9 Agonist, Combined With Local Radiation for Patients With Recurrent Mycosis Fungoides.	NCT00226993	Mycosis Fungoid...	CPG 7909	18 Years -	Stanford University
CPG 7909 + Local Radiotherapy in Recurrent Low-Grade Lymphomas	NCT00185965	Non-Hodgkin Lym... Mycosis Fungoid...	CPG 7909	18 Years -	Stanford University
A Dose Finding Study of CpG in Patients With Chronic Lymphocytic Leukemia Who Have Been Previously Treated	NCT00233506	Chronic Lymphoc...	CpG 7909	18 Years -	University of Iowa
A Dose Finding Study of CpG in Patients With Chronic Lymphocytic Leukemia Who Have Been Previously Treated	NCT00233506	Chronic Lymphoc...	CpG 7909	18 Years -	University of Iowa
CPG 7909 in Patients Wih Stage IV Renal Cell Cancer	NCT00043407	Carcinoma, Rena...	CPG 7909	18 Years -	Pfizer
Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer	NCT00031278	Carcinoma, Meta...	CPG 7909 Herceptin® CPG 7909 Herceptin® CPG 7909 Herceptin® CPG 7909 Herceptin®	18 Years -	Pfizer
CPG 7909 Injection in Non-Small Cell Lung Cancer	NCT00070629	Carcinoma, Non-...	CPG 7909 Chemotherapy Chemotherapy	18 Years -	Pfizer
CPG 7909 Injection in Non-Small Cell Lung Cancer	NCT00070629	Carcinoma, Non-...	CPG 7909 Chemotherapy Chemotherapy	18 Years -	Pfizer
A Pilot Study of NY-ESO-1b Peptide Plus CpG 7909 and Montanide® ISA-51 in Patients With Cancer.	NCT00199836	Cancer Neoplasm	NY-ESO-1b pepti...	18 Years -	Ludwig Institute for Cancer Research

Spots Global Cancer Trial Database for cpg 7909

Every month we try and update this database with for cpg 7909 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 cpg 7909

Every month we try and update this database with for cpg 7909 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 cpg 7909 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.