Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Vaccines

Molgramostim

Sargramostim

Immunologic Factors

In the Dose Ranging part of the study, cohorts of 3 patients will be treated at increasing dose levels of GM-CSF DNA delivered subcutaneously (100, 400, or 800 mg), followed by administration of both peptides subcutaneously to the same site on day 5 or day 6. Patients will be treated monthly for three immunizations.

GM-CSF DNA, NSC 683472 gp100: 209-217(210M), NSC 699048 Tyrosinase: 368-376(370D)

Miguel-Angel Perales, MD

This is a pilot trial to investigate the use of GM-CSF DNA as an adjuvant for peptide vaccination in patients with metastatic melanoma. The objective of this study is to determine the safety and adjuvant effect of vaccination with the gene coding for human GM-CSF with a multi-epitope melanoma peptide vaccine (tyrosinase and gp100 peptides) in patients with AJCC stage IIB, IIC, III and IV melanoma who are HLA-A2+. We will assess whether use of GM-CSF DNA is safe and generates an immune response to peptides derived from antigens on melanoma cells.

This is a pilot trial to investigate the use of GM-CSF DNA as an adjuvant for peptide vaccination in patients with metastatic melanoma. The objective of this study is to determine the safety and adjuvant effect of vaccination with the gene coding for human GM-CSF with a multi-epitope melanoma peptide vaccine (tyrosinase and gp100 peptides) in patients with AJCC stage IIB, IIC, III and IV melanoma who are HLA-A2+. We will assess whether use of GM-CSF DNA is safe and generates an immune response to peptides derived from antigens on melanoma cells.

In the Dose Ranging part of the study, cohorts of 3 patients will be treated at increasing dose levels of GM-CSF DNA delivered subcutaneously (100, 400, or 800 ug), followed by administration of both peptides subcutaneously to the same site on day 5 or day 6. Patients will be treated monthly for three immunizations. Pharmacokinetic studies will be performed during the first cycle. Patients' peripheral blood mononuclear cells will be collected in order to measure the T cell responses induced by the vaccines. Toxicity will be assessed during this part of the study, although we do not expect to achieve a dose limiting toxicity (DLT). The dose for the second part of the study will be the maximum tolerated dose.

The second part of the study will assess the immunological efficacy of the vaccine. Nine patients will receive GM-CSF DNA delivered subcutaneously at one site, followed by administration of both peptides to the same site on day 5 or day 6, every month for three immunizations. A total of at least 18 patients is planned for both phases of the study. Patients' peripheral blood mononuclear cells will be collected in order to measure the T cell responses induced by the vaccines. Specifically, Elispot assays for CD8+ T cells responses against the peptides will be assessed, and will be the primary method to determine the generation of a specific immune response to the peptide antigens.

Injection Of AJCC Stage IIB, IIC, III And IV Melanoma Patients With A Multi-Epitope Peptide Vaccine Using GM-CSF DNA As An Adjuvant: A Pilot Trial To Assess Safety And Immunity

National Cancer Institute (NCI)

Memorial Sloan Kettering Cancer Center

Miguel-Angel Perales

Digestive System Diseases

Adenocarcinoma

Rectal Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Camurati-Engelmann Disease

Capecitabine

Fluorouracil

Immunomodulating Agents

Mitogens

Antimetabolites

Immunosuppressive Agents

Patients will receive a 14 day course of LY2157299. On day 15 patients will begin chemoradiation treatment with Capecitabine or Fluorouracil. On day 29, patients will undergo another fourteen day course of LY2157299 concurrent with their ongoing chemoradiation treatment. Six to ten weeks after completing their neoadjuvant therapy, patient will undergo a tumor specific mesorectal excision as per standard of care.

Small molecule inhibitor of transforming growth factor-beta signaling pathway

LY2157299

Tumor specific mesorectal excision

Kristina Young, MD, PhD

Todd Crocenzi, MD

The purpose of this study is to see how effective and safe LY2157299, in combination with chemotherapy and radiation therapy, might be in treating rectal cancer. Also as part of this study, research will be done on tumor samples to see if it is possible to predict if patients will respond to treatment, and blood samples to look at the immune system response to study treatment.

About 50 people will take part in this study. The study treatment will be given over an 8 week period and the investigators will continue to collect your health information for up to 5 years, as part of this study

This is a prospective Phase II study to test the efficacy of LY2157299 in combination with neoadjuvant chemoradiation in patients with rectal adenocarcinoma. This study will test the hypothesis that LY2157299 will improve effector T cell tumor infiltration and activity resulting in improved pathologic response rates. The investigators propose that this improved immune response will result in improved disease-free and overall survival.

The objectives are:

1. Determine the rate of pathologic complete response in patients with locally advanced rectal adenocarcinoma treated with neoadjuvant chemoradiation and the investigational agent LY2157299
2. Correlate immunoscore changes prior to therapy, during therapy, and at surgical resection with pathologic response and MRI parameters
3. Immune monitoring to evaluate potential biomarkers of treatment success.

Eligible patients will have histologically confirmed rectal adenocarcinoma, AJCC Stage IIA IIIC or AJCC Stage IV appropriate for consideration of primary rectal tumor resection. Patients will undergo a forceps biopsy of the rectal mass as part of the diagnostic workup as well as undergo staging evaluation including an MRI with additional study sequences. Enrolled patients will receive a 14 day course of LY2157299 followed by a repeat biopsy and MRI with study sequences. In this trial the investigators plan to use the maximum tolerated dose of LY2157299 established in human clinical trials, 300mg delivered as 150mg P.O. BID. On day 15 patients will begin chemoradiation with either 5-FU (fluorouracil ) or capecitabine (Xeloda®). On day 29, patients will undergo another fourteen day course of LY2157299 concurrent with their ongoing chemoradiation.

Patients will undergo 50.4 to 54Gy of radiation in 1.8Gy daily fractions delivered Monday through Friday for a total of 28-30 fractions. The acceptable duration of chemoradiation, including treatment breaks or delays, is up to 8 weeks total. Six to ten weeks after completing their neoadjuvant therapy, patient will undergo a tumor specific mesorectal excision as per standard of care with evaluation of pathologic response rate. Patients will be followed for disease-free survival, progression free survival, local recurrence, and overall survival. A three patient safety lead-in will be performed, where a six week safety period following completion of radiation will be completed prior to enrolling subsequent patients.

ExIST Study of LY2157299 (Galunisertib) in Rectal Cancer

Phase II Study of TGFβ Type I Receptor Inhibitor LY2157299 With Neoadjuvant Chemoradiation in Patients With Locally Advanced Rectal Adenocarcinoma

Complete response is defined as no viable tumor cells identified.

For the immunoscore, a value of 0 or 1 is assigned to each cell population of interest with 0 corresponding to a poor immune infiltrate and 1 corresponding to a favorable immune infiltrate as determined by immunohistochemistry.

Investigators will test a minimum of three MRI parameters including but not limited to ADC and f_p from the IVIM sequence, and Ktrans from the DCE sequence.

The immunologic monitoring parameters will be combined to arrive at an aggregated measure of "pro-tumor immune environment" or "anti-tumor immune environment" using cell counts derived from flow cytometry of peripheral blood and serum measures of inflammation.

Eli Lilly and Company

Providence Health & Services

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

Cetuximab

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Cetuximab was administered weekly at an initial dose (Week 1) of 400 mg/m2 IV infusion and a weekly maintenance dose of 250 mg/m2 IV infusion.

Paclitaxel 225 mg/m2 infused over 180 minutes on Day 1 and subsequently every 3 weeks.

Carboplatin (AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 3 weeks.

Cetuximab was administered weekly at an initial dose (Week 1) of 400 mg/m2 IV infusion and a weekly maintenance dose of 250 mg/m2 IV infusion.

Paclitaxel 100 mg/m2 infused over 180 minutes on Day 1, Day 8 and Day 15 of a 4-week cycle.

Carboplatin (AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 4 weeks.

(Week 1) of 400 mg/m2 IV infusion and a weekly maintenance dose of 250 mg/m2 IV infusion.

A cycle of therapy was defined as 3 weeks in Arm A and 4 weeks in Arm B.

(AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 3 weeks (AUC = 6) was infused over 30 minutes on Day 1 and subsequently every 4 weeks.

225 mg/m2 infused over 180 minutes on Day 1 and subsequently every 3 weeks. OR 100 mg/m2 infused over 180 minutes on Day 1, Day 8 and Day 15 of a 4-week cycle.

E-mail: ClinicalTrials@ ImClone.com

The purpose of the study is to determine if the combination of cetuximab, carboplatin and paclitaxel will shrink a specific type of lung cancer known as non-small cell lung cancer (NSCLC). The safety of this combination will also be evaluated.

Lung cancer is the second most common cancer diagnosed for both genders in the United States. Approximately 173,770 new cases are estimated for 2004. It is the leading cause of cancer deaths in both men and women, with approximately 160,440 deaths estimated for 2004. Prognosis for many is poor if not diagnosed at an early stage, and therapy for advanced disease is limited. The study will test two chemotherapy agents, carboplatin and paclitaxel, in combination with a newly approved drug called cetuximab, which is continuing to be tested in colorectal cancer and other cancers. Cetuximab is a monoclonal antibody, which is believed to work by attaching to an epidermal growth factor receptor (EGFR) on tumor cells and thereby blocking tumor cells from reproducing. It is an antibody to the EGFR. Fifty percent of lung cancers overexpress EGFR.

Rationale:

The present study is built upon the data from previous studies, incorporating cetuximab into each of two regimens of paclitaxel plus carboplatin. The results of prior studies using paclitaxel and carboplatin demonstrate that these drugs in combination, using a variety of schedules, are both safe and effective as therapy for advanced or metastatic NSCLC. The addition of biologic therapy with the anti-EGFR agent cetuximab to the combination will presumably maximize the therapeutic index while keeping toxicity to a minimum in patients with Stage IIIB/IV NSCLC.

Research Hypothesis:

Subjects with previously-untreated stage IIIB/IV NSCLC who receive a combination of paclitaxel, carboplatin, and cetuximab will have a progression-free survival rate greater than that previously reported for subjects receiving the combination of paclitaxel and carboplatin.

Trial of Carboplatin/Paclitaxel/Cetuximab in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)

A Randomized Phase II Trial of Two Dose Schedules of Carboplatin/Paclitaxel/Cetuximab in Stage IIIB/IV Non-small Cell Lung Cancer

Bristol-Myers Squibb

Chief Medical Officer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Injection Of AJCC Stage IIB, IIC, III And IV Melanoma Patients With A Multi-Epitope Peptide Vaccine Using GM-CSF DNA As An Adjuvant: A Pilot Trial To Assess Safety And Immunity	NCT00580060	Melanoma	GM-CSF DNA, NSC...	-	Memorial Sloan Kettering Cancer Center
ExIST Study of LY2157299 (Galunisertib) in Rectal Cancer	NCT02688712	Rectal Adenocar...	LY2157299 Capecitabine Fluorouracil Tumor specific ...	18 Years -	Providence Health & Services
Trial of Carboplatin/Paclitaxel/Cetuximab in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)	NCT00097227	Non-small Cell ...	Cetuximab Carboplatin Paclitaxel	18 Years -	Eli Lilly and Company

Spots Global Cancer Trial Database for iv

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

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