EphA2 Gene Targeting Using Neutral Liposomal Small Interfering RNA Delivery - Full Text View - ClinicalTrials.gov Phase 1 solid tumors

EphA2 Gene Targeting Using Neutral Liposomal Small Interfering RNA Delivery - Full Text View - ClinicalTrials.gov

Official Title:

EphA2 Gene Targeting Using Neutral Liposomal Small Interfering RNA Delivery (IND# 72924): A Phase I Clinical Trial

This study is not yet open for participant recruitment.

Verified May 2012 by M.D. Anderson Cancer Center

First Received on May 2, 2012.   No Changes Posted

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Ovarian Cancer Research Fund
Information provided by (Responsible Party):	M.D. Anderson Cancer Center ( M.D. Anderson Cancer Center )
ClinicalTrials.gov Identifier:	NCT01591356

  Purpose

The goal of this clinical research study is to learn about the safety of siRNA-EphA2-DOPC when given to patients with advanced, recurrent cancer. Researchers also want to learn the highest tolerable dose of this drug that can be given.

siRNA-EphA2-DOPC is designed to shut down the activity of a gene that causes tumor growth.

Phase I Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer - Full Text View - ClinicalTrials.gov

Phase I Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer - Full Text View - ClinicalTrials.gov

Phase I Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer

This study is currently recruiting participants.

Verified April 2012 by Stanford University

First Received on December 13, 2011.   Last Updated on April 18, 2012   History of Changes

Sponsor:	Stanford University
Information provided by (Responsible Party):	Stanford University
ClinicalTrials.gov Identifier:	NCT01494012

  Purpose

This phase I trial studies the side effects and the best dose of stereotactic body radiation therapy (SBRT) in treating patients with metastatic or recurrent ovarian cancer or primary peritoneal cancer. SBRT may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

financial news: ImmunoGen Says IND For Anticancer Compound IMGN853 Is Now Active

ImmunoGen Says IND For Anticancer Compound IMGN853 Is Now Active


(RTTNews.com) - ImmunoGen, Inc. (IMGN) announced that the Investigational New Drug, or IND, application for its IMGN853 product candidate is now active. IMGN853 is a potential new therapeutic for ovarian cancer, non-small cell lung cancer and other epithelial malignancies which over-express folate receptor 1, or FOLR1.
The company expects Phase I evaluation of IMGN853 to commence in the middle of 2012.....

abstract: Phase I trial of intraperitoneal pemetrexed, cisplatin, and paclitaxel in optimally debulked ovarian cancer.

Phase I trial of intraperitoneal pemetrexed, cisplatin, and paclitaxel in optimally debulked ovarian cancer.

Abstract

PURPOSE:

This phase I trial evaluated intraperitoneal (IP) pemetrexed, cisplatin, and paclitaxel in optimally debulked ovarian cancer.

Phase 1 - TKM 080301 for Primary or Secondary Liver Cancer - Full Text View - ClinicalTrials.gov (ovariancolorectal/pancreas/gastric (stomach)/breast)

TKM 080301 for Primary or Secondary Liver Cancer - Full Text View - ClinicalTrials.gov

Colorectal Cancer With Hepatic Metastases
Pancreas Cancer With Hepatic Metastase
Gastric Cancer With Hepatic Metastase
Breast Cancer With Hepatic Metastase
Ovarian Cancer With Hepatic Metastase

TKM 080301 for Primary or Secondary Liver Cancer

This study is currently recruiting participants.

Verified February 2012 by National Institutes of Health Clinical Center (CC)

First Received on September 16, 2011.   Last Updated on March 9, 2012   History of Changes

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT01437007

  Purpose

Background:

Cancer in the liver can start in the liver (e.g., primary liver cancer or hepatocellular cancer) or spread to the liver from cancers in other parts of the body (e.g. colon, pancreas, gastric, breast, ovarian, esophageal cancers, cancer with metastases to the liver.) People who have tumors that can be removed by surgery live longer than those whose cancer cannot be removed. Chemotherapy can shrink some tumors in the liver, which also helps people to live longer, and sometimes chemotherapy can shrink tumors enough that they can be removed by surgery. However, most chemotherapy drugs do not work well on tumors in the liver. In this study we are testing a new drug, TKM-080301, given directly into the cancer blood supply in the liver circulation, to see if it will cause tumors to shrink.

Objectives:

- To test the safety and effectiveness of TKM-080301 for cancer in the liver that has not responded to standard treatments.

DPX-Survivac vaccine - Biotech company raises $2.8 million for R&D | The Chronicle Herald

"Halifax biotechnology company Immunovaccine Inc. has raised $2.8 million in equity funding that will help the company push forward with clinical trials of its anti-cancer vaccine.

“The proceeds will be used to fund research and development and for our other corporate activities,” Immunovaccine chief financial officer Kimberley Stevens said Wednesday.

Foremost among those R&D efforts are the Phase 1 clinical trails on patients with advanced-stage ovarian cancer for DPX-Survivac, Immunovaccine’s therapeutic cancer vaccine. In January, the first patient was vaccinated in the trials, which have been simultaneously approved in Canada and the United States.

The company, through the non-brokered private placement, issued 9,294,005 common shares at 30 cents each to raise the funds.
Under Phase 1 trials, patients in Canada and the United States will be treated with DPX-Survivac after completing debulking surgery — the removal of part of a tumour — and chemotherapy treatments.
If the vaccine is found to be safe for humans, testing will proceed to Phase 2.

Typically, if a vaccine passes Phase 2, the company either licenses it or partners with a big drug company before beginning definitive tests that regulatory agencies use to decide whether to approve a product.
Stevens said the $2.8 million in fresh equity will be enough for Immunovaccine to operate until the first quarter of 2013 before it needs to raise new funds.

abstract: Phase I clinical and pharmacokinetic study of trabectedin and carboplatin in patients with advanced solid tumors (including OC)

Phase I clinical and pharmacokinetic study of trabectedin and carboplatin in patients with advanced solid tumors.

Investigational new Drugs [2012, 30(2):616-28]

Purpose
This study intended to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RD) of trabectedin combined with carboplatin in patients with advanced solid tumors.

Patients and methods
Carboplatin-pretreated patients received carboplatin AUC 4 (Group 1), whereas carboplatin-naïve patients received carboplatin AUC 5 (Group 2) as a 1-h i.v. infusion followed by trabectedin at dose range from 0.5-1.2 mg/m(2) in the schedule of 3-h/every-3-weeks. Pharmacokinetic (PK) sampling was performed in the first 2 cycles.

Results
Forty-four patients were treated and evaluable for safety and dose-limiting toxicities (DLTs). In Group 1, at trabectedin 1.0 mg/m(2), cumulative hematological toxicity was found in all patients and 1/10 patients had DLTs. The RD was considered trabectedin 0.8 mg/m(2) combined with carboplatin AUC 4. Although no DLT occurred at this dose level, frequent dose delays (28.6%) and the 4-week cycle re-scheduling (66.7%) were required. In Group 2, DLTs occurred at trabectedin 0.8 mg/m(2) (3/8 patients), 1.0 mg/m(2) (3/10 patients) and 1.2 mg/m(2) (2/2 patients) with cumulative hematological toxicity associated with an important number of transfusions. In this group, neither the MTD nor the RD were established. Promising antitumor activity was found for this carboplatin/trabectedin combination; especially in patients with advanced ovarian cancer and soft tissue sarcoma. No significant PK drug-drug interaction occurred.

Conclusions
This study established a trabectedin dose of 0.8 mg/m(2) combined with carboplatin AUC 4 and given every 4 weeks as the most feasible schedule in carboplatin-pretreated patients. Dose and cycle recommendations for carboplatin-naïve patients warrant further evaluation.

abstract: A Phase I Study of Veliparib in Combination with Metronomic Cyclophosphamide in Adults with Refractory Solid Tumors and Lymphomas (brca/triple negative bc)

CONCLUSIONS:

The combination of veliparib with metronomic cyclophosphamide is well tolerated and shows promising activity in a subset of patients with BRCA mutations. A phase II trial of the combination compared to single-agent cyclophosphamide is ongoing in BRCA-positive ovarian cancer, triple-negative breast cancer, and low-grade lymphoma.

not yet recruiting - Phase 1 Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors - Full Text View - ClinicalTrials.gov

UK phase 1 - ADZ5363 - New cancer drug to be tested by patients - Business News - Healthcare Digital

"Medication that prevents the enzyme, Protein Kinase B (PKB), has the potential to treat breast cancer, prostate cancer, ovarian cancer, pancreatic cancer and gastric cancers.

The Royal Marsden NHS Foundation Trust and the Christie Hospital NHS Trust in the UK are going to be involved in testing the drug, along with a hospital in the Netherlands.

Scientists and doctors are looking for patients with advanced solid tumours to test the drug, in order to determine the safety, tolerability and initial anti-cancer activity of ADZ5363....."

full free access (pdf): A phase I study with an expanded cohort to assess the feasibility of intraperitoneal carboplatin and intravenous paclitaxel in untreated ovarian, fallopian tube, and primary peritoneal carcinoma: A Gynecologic Oncology Group study

Research Highlights

► The MTD (maxium tolerated dose) of IP carboplatin with IV paclitaxel (175 mg/m²) was an AUC 8.
►IP carboplatin can be given with IV paclitaxel over multiple cycles at an AUC 6.
►Dose-limiting toxicities of IP carboplatin were thrombocytopenia and leukopenia.

Phase 1/pharmacology study of intraperitoneal topotecan alone and with cisplatin: potential for consolidation in ovarian cancer.

Phase I Study of Vorinostat in Patients With Advanced Solid Tumors and Hepatic Dysfunction: A National Cancer Institute Organ Dysfunction Working Group Study — JCO

Note: abstract does not indicate if ovarian cancer patients were included in this phase 1 study

First-in-human trial of a poly(ADP-ribose) polymerase (PARP) inhibitor MK-4827 in advanced cancer patients (pts) with antitumor activity in BRCA-deficient and sporadic ovarian cancers (phase 1)

Results: 39 pts (male 10, female 29; median age 58 years; 11 BRCA mutation carriers) were treated...
Conclusions: MK-4827 is well tolerated, blocks PARP and has promising antitumor activity in both BRCA-deficient and sporadic cancers.

Phase I clinical trials in 85 patients with gynecologic cancer: The M. D. Anderson Cancer Center experience

Note: the abstract does not detail outcomes/disease specific sites

med blog: You Shouldn't Call Something a Breakthrough When It's in a Phase I Trial

MLN8237 in Patients With Ovarian, Fallopian Tube or Peritoneal Cancer Preceded by Phase 1 Study of MLN8237 Plus Paclitaxel Treatment of Ovary or Breast Cancer

Intensity-modulated whole abdominal radiotherapy after surgery and carboplatin/taxane chemotherapy for advanced ovarian cancer: phase I study

CONCLUSIONS: The results of this Phase I study showed for the first time, to our knowledge, the clinical feasibility of intensity-modulated whole abdominal radiotherapy, which could offer a new therapeutic option for consolidation treatment of advanced ovarian carcinoma after adjuvant chemotherapy in selected subgroups of patients. We initiated a Phase II study to further evaluate the toxicity of this intensive multimodal treatment.

utube - Deborah Armstrong, MD, Johns Hopkins Kimmel Cancer Center, discusses Early studies of enzastaurin and bevacizumab.SGO

free full access: A phase-I trial of pemetrexed plus carboplatin in recurrent ovarian cancer.

for full free access click on 'pdf'