Summary

Sunitinib (Sutent) may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial in which all patients receive a defined therapy (no one receives a placebo/sugar pill) is studying how well sunitinib works in treating patients with metastatic, locally advanced, or locally recurrent chordomas. A similar trial using Sutent for patients with sarcomas has reached maximum enrollment and this trial has been opened specifically for 20 chordoma patients.

Locations

Note: when calling, make sure to specify that your chordoma is a type of sarcoma

Memorial Sloan - Kettering Cancer Center
New York, New York
Phone: 800-525-2225 (M- F 9:00am -5:00pm EST)

Eligibility

Age: 18 or older

Inclusion criteria:
1) Individuals with metastatic and/or locally advanced or recurrent chordomas
2) Chordoma confirmed by pathologists at Memorial MSKCC
3) May have had up to three previous chemotherapy treatments for recurrent or metastatic chordoma, with the last dose 2 weeks or more prior to registration
4) May have had previous radiation with last dose 3 weeks or more prior to registration
5) Must be able to swallow medications
6) Must have normal organ and bone marrow function
7) Agree to use birth control or abstinence prior and during the entire time of the study to avoid pregnancy while on medications
8) Must be able to understand and sign an informed written consent

Exclusion Criteria:
1) Previous treatment with Sutent
2) 4 or more previous treatments with chemotherapy
3) Radiation treatment within 3 weeks prior to registration
4) Use of other investigational medications or treatments
5) Women who are pregnant and/or breast feeding
6) Any of the following diagnosis within 6 months of registration – Heart attack, Coronary Bypass surgery, Severe or Unstable Angina, Congestive Heart Failure, Stroke, Transient Ischemic Attack (TIA) or Lung Clot (pulmonary embolism)
7) Any of the following medical conditions – bleeding disorders (no hemorrhage within 4 weeks), Severe heart arrhythmias (abnormal beats), uncontrolled thyroid disease, prolonged Q-T interval on EKG, uncontrolled high blood pressure (>150/100), psychiatric illness,
8) People will be excluded if they are taking the following medications:Blood thinners, Theophyline, Seizure drugs (phenytoin, carbamazepine, or Phenobarbital), Ketoconazole or Rifampin

About Sutent from the manufacturer

How does SUTENT work?
What to tell the doctor
Taking SUTENT
Side effects
Managing side effects
Important safety information

Summary

Preliminary response data, observed by Casali (Cancer, 2004) with imatinib 800 mg/day in patients affected by chordoma, need to be confirmed by a Phase II study, whose primary endpoint will be the formal assessment of clinical and pathological response. Aim of the study will be to explore treatment’s activity, but also the potential impact of tumor response, the feasibility and outcome of subsequent surgery and radiotherapy. In addition, patterns of tumour response need to be investigated as well, given the peculiar patterns of response shown with molecular-targeted therapy in solid tumors.

Full Trial Description

Location

Istituto Nazionale Tumori
Milan, Italy
Phone: +39 2 2390 2803
Principal Investigator: Paolo Casali, MD, paolo.casali@istitutotumori.mi.it

About Gleevec from the manufacturer (USA)

About Glivec from the manufacturer (International)

Publications on the use of Imatinib for Chordoma

1. Stacchiotti, S., et al., 2007. Imatinib mesylate in advanced chordoma: A multicenter phase II study. Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I. Vol 25, No. 18S (June 20 Supplement)
2. Casali, P. G., et al., 2004. Imatinib mesylate in chordoma. Cancer. 101, 2086-2097.

Summary

This study will examine the response rate and the 6-month progression-free survival rates of patients with advanced sarcoma treated with dasatinib (Sprycel).

Full trial description

Locations

Washington Cancer Institute
Washington, District of Columbia
Contact: Jake Patterson, jake.w.patterson@medstar.net
Phone: 202-877-5371
Principal Investigator: Dennis A Priebat, MD,

University of Michigan
Ann Arbor, Michigan
Contact: Gino Metko, ginom@med.umich.edu
Phone: 734-647-2095
Principal Investigator: Scott Schuetze, MD, PhD

Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania
Contact: Deb Riordan, RN, BS, debbieriordan@pennoncology.com
Phone: 215-829-6712
Principal Investigator: Arthur Staddon, MD

About Sprycel from the manufacturer

Patient information sheet

Important safety information

Summary

The purpose of this study is to explore how sarcomas are affected by a new medication, cetuximab. Cetuximab is directed towards a protein called EGFR (epidermal growth factor receptor), that is found in some types of cancer. Studies have shown that this drug can be beneficial in patients with colon cancer and has been approved by the US Food and Drug Administration (FDA) for this purpose. The researchers are conducting a study to see if it is beneficial in patients with sarcoma.

Full Trial Description

Location

Note: when calling, make sure to specify that your chordoma is a type of sarcoma

University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Phone: 800-865-1125
Principal Investigator: Rashmi Chugh, M.D.

About ERBITUX from the manufacturer (USA)

What is ERBITUX

How does ERBITUX work?

About Cetuximab from the manufacturer (International)

Publications on the use of Cetuximab for Chordoma

1. Effectiveness of Cetuximab/Gefitinib in the Therapy of a Sacral Chordoma

Summary

Proton therapy is a kind of external beam radiation therapy where protons are directed to a tumor site. Researchers are trying to determine what level of proton therapy gives the most benefit without causing toxic side effects. Researchers will also be testing the treatment's effect. All participants will receive proton beam therapy 1 time a day. One group will receive a higher dose level than the other group (70 Gy versus 78 Gy). About 75 participants will take part in this study.

Full Trial Description

Location

M.D. Anderson Cancer Center
Houston, Texas, United States
Phone: 713-563-2300
Principal Investigator: Eric L. Chang, MD

About the M.D. Anderson Proton Beam Center

Summary

While most people with chordoma have no other family members with the disease, rare occurrences of multiple cases within families have been documented. This suggests that some people may be genetically predisposed to develop chordoma. Because genetic or hereditary risk factors for chordoma may exist, scientists are searching for genes involved in the development of this tumor.

Researchers seek to enroll families that meet one of the following criteria: have at least two blood relatives with a history of chordoma; have one family member with a history of chordoma and at least one blood relative with a history of a childhood brain tumor; or have one family member diagnosed with chordoma at age 20 or younger. See the full list of eligibility criteria for this trial.

Knowing your family’s health history essential. If more than one family member has a chordoma, then the entire family is at high risk, and others may in fact already have undiagnosed tumors. Relatives at high genetic risk should be screened for chordomas along the entire neuroaxis (head to tail). By participating in the NCI Familial Chordoma Study, all blood relatives in a “chordoma family” will receive thorough evaluations, including MRI, at no charge. Early screening and diagnosis in asymptomatic family members could be lifesaving.

Full Trial Description

Location

NIH Clinical Center
Bethesda, Maryland, United States
Phone: 1-800-518-8474
Principal Investigators: Dilys Parry, PhD and Margaret Tucker, MD