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Clinical Trial News

Abstracts by Tom Swartz

 

[Editor's Note: Because the Clinical Trial News column is so highly accessed, we have reduced the need for you to "search" back issues of ESUN to locate clinical study information. We have created three separate webpages where all of the clinical trial information that we have published in ESUN to date has been collected. You can read about these changes in the editorial, Changes Made, in the October 2006 issue of ESUN. With the addition of the clinical trials described in this issue of ESUN, we now have over 250 clinical trials listed on our website.]

 

Currently Accepting Eligible Patients (not previously published in ESUN)

 

A Multiple Ascending Dose Study of R1507 in Children and Adolescents With Advanced Solid Tumors

This Phase I trial is currently recruiting patients. This 3 arm study will determine the dose of R1507 which will achieve a mean drug exposure in children and adolescents with advanced solid tumors equivalent to the exposure achieved in adults at the recommended dose of 9mg/kg/week. It will also determine the maximum tolerated dose (if appropriate) and the pharmacokinetic profile of R1507. Groups of patients will be sequentially enrolled in one of up to 3 dose levels (3,9mg/kg or a PK-derived dose, not to exceed 16 mg/kg) of R1507 administered weekly by intravenous infusion. An expanded cohort of patients will be enrolled at the optimal dose/MTD. The anticipated time on study treatment is until disease progression or dose limiting toxicity, and the target sample size is < 100 individuals. Patients between 2 and 17 years of age are eligible. This trial is taking place in: Arizona, Colorado, Maryland, New York, and Texas.

 

Registry Information

Official Title:  Multiple Ascending Dose (MAD) Study of the IGF-1R Antagonist R1507 Administered as an Intravenous Infusion in Pediatric Patients With Advanced Solid Tumors

Registered in ClinicalTrials.gov: NCT00560144

Information Last Updated: January 18, 2008

 

Safety Study of SGX523, a Small Molecule Met Inhibitor, to Treat Solid Tumors

This Phase I trial is currently recruiting patients. SGX523 is a drug which acts by blocking the function of an enzyme called MET. MET activity may be important in growth and survival of some types of cancer. This trial is studying the safety, side effects, and best dose of SGX523 when given to patients with advanced cancer, and how well it inhibits MET activity in tumors. The estimated enrollment is 46 patients. Patients 18 years of age and older are eligible. This trial is taking place in Arizona.

 

Registry Information

Official Title:  A Phase I, Multi-Center, Open Label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Orally Administered SGX523, a Small Molecule Anti-Cancer Agent, On a Twice Daily, Interrupted Schedule in Patients With Advanced Cancer

Registered in ClinicalTrials.gov: NCT00607399

Information Last Updated: January 23, 2008

 

Phase 1, Open-Label, Dose Escalation Study of TRC093, in Patients With Locally Advanced or Metastatic Solid Tumors

This Phase I trial is currently recruiting patients. TRC093 is a humanized monoclonal antibody to cleaved collagen. This study is being performed to evaluate the safety and tolerability of the TRC093 antibody. It will be administered by IV on days 1 and 15 of each 28 day cycle until progression or unacceptable toxicity develops. The estimated enrollment is 24 patients. Patients 18 years of age and older are eligible. This trial is taking place at centers in Alabama, Arizona, and California.

 

Registry Information

Official Title:  A Phase 1, Open-Label, Dose Escalation Study of the Humanized Monoclonal Antibody, TRC093, in Patients With Locally Advanced or Metastatic Solid Tumors

Registered in ClinicalTrials.gov: NCT00492830

Information Last Updated: December 19, 2007

 

A Phase 1 Study of STA-9090, Administered Once-Weekly in Patients with Solid Tumors

This is a Phase I study of the HSP90 Inhibitor, STA-9090, Administered Once-Weekly in Patients with Solid Tumors. This is a dose-escalation study. The first cohort will consist of three patients who will receive STA 9090 during a 1-hour infusion once per week for three consecutive weeks followed by a 1 week dose-free interval. Subsequent cohorts will receive higher amounts of STA-9090 provided that the previous dose was well tolerated during cycle 1 (week 1 – 4). Dose escalation will continue until the maximum tolerated dose (MTD) is determined. For further information contact: Pilar De La Roche Mur, Dana Farber Cancer Institute, Boston, MA 02115; Telephone: 617-632-5841 or Dr. Patricia LoRusso. Wayne State University Karmanos Cancer Institute, Detroit, MI 48201. Telephone: 313-576-8716

 

Registry Information

No registry information currently available

 

Currently Accepting Eligible Patients (previously published in ESUN and additional information is now available)

Ariad has set us the most current list of open United State study sites for the SUCCEED trial which was discussed in the last issue of ESUN. You can download a copy of the SUCCEED Patient and Caregiver brochure by clicking here.

 

Principal Investigator

Site Name

Location

Maurice Berkowitz, MD

Kenmar Research Institute

Los Angeles

Sant Chawla, MD

Sarcoma Oncology Center

Santa Monica

George D. Demetri, MD 

Sarcoma Center, Dana-Farber Cancer Institute

Boston

Dr. Ronald Drengler, MD

South Texas Oncology & Hematology PA

San Antonio

Nashat Y. Gabrail, MD

Gabrail Cancer Center

Canton

W. Graydon Harker, MD

Utah Cancer Specialists

Salt Lake City

Ali Khojasteh, MD

Columbia Comprehensive Cancer Care Center

Columbia, MO

Brian Samuels, MD

North Idaho Cancer Center

Coeur D'Alene

Alexander Spira, MD

Fairfax Northern VA Hemotology/Oncology

Fairfax

Arthur Staddon, MD

Joan Kamell Cancer Center, Pennsylvania Hospital

Philadelphia

Samir Undevia, MD

University of Chicago-Sect of Hematology/Oncology

Chicago

 

Currently Accepting Eligible Patients (not previously published in ESUN)

 

No entries in this category this issue

 

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