Trials Sponsors Conditions Drugs Pricing

Conditions

Keywords

Brain TumorCentral Nervous SystemCNSSpinal Cord TumorAnaplastic EpendymomaSupratentorial EpendymomaInfratentorial EpendymomaSpinal Cord EpendymomaLapatinibGW572016TemozolomideTemodar

Outcome Measures

Primary Outcomes (1)

Time to Progression
Time to progression defined as progressive disease, toxicity at a level of severity that precludes the patient continuing on the protocol, or death. Progression is a 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
Assessed every two months till disease progression, up to 4 years

Secondary Outcomes (2)

Number of Participants With an Overall Response (Complete Response or Partial Response) Assessed by the MacDonald Criteria
4 weeks

Study Arms (1)

Temozolomide + Lapatinib

EXPERIMENTAL

Temozolomide starting dose 125 mg/m\^2 daily by mouth on days 1-7 \& 15-21 of a 28 day cycle. Lapatinib starting dose 1250 mg daily by mouth.

Drug: TemozolomideDrug: Lapatinib

Interventions

TemozolomideDrug

Starting dose 125 mg/m\^2 daily by mouth on days 1-7 \& 15-21 of a 28 day cycle.

Also known as: Temodar

Temozolomide + Lapatinib

LapatinibDrug

Starting dose 1250 mg daily by mouth.

Also known as: GW572016

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Histologically proven ependymoma or anaplastic ependymoma. There must be pathologic or imaging confirmation of tumor progression or regrowth. The patients histologic diagnosis must be confirmed on Central Pathology Review prior to registration Step 2.
History and physical examination, including neurologic examination, within 2 weeks prior to registration.

Sponsors & Collaborators

CERN Foundation - Collaborative Ependymoma Research Network
Research networkcollaborator
National Institutes of Health Clinical Center (CC)
NIHlead

Study Sites (6)

University of California, San Francisco

San Francisco, California, 94143, United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

University of Pittsburgh Medical Center - Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

MeSH Terms

Conditions

Brain NeoplasmsSpinal Cord NeoplasmsEpendymoma

Interventions

TemozolomideLapatinib

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesGlioma

Results Point of Contact

Title: Dr. Mark Gilbert
Organization: National Cancer Institute

Study Officials

Marta Penas-Prado, MD
M.D. Anderson Cancer Center
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

58 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: NIH
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

January 20, 2009

First Posted

January 22, 2009

Study Start

January 2009

Actual (reported)

You may not qualify if:

Prior invasive malignancy that is not the ependymoma (except non-melanomatous skin cancer or carcinoma in situ of the cervix) unless the patient has been disease free and off therapy for that disease for a minimum of 3 years
Transmural myocardial infarction or unstable angina within 3 months prior to study registration
Evidence of recent myocardial infarction or ischemia by the findings of S-T elevations of \>/= 2 mm using the analysis of an electrocardiography (EKG) performed within 14 days prior to registration
New York Heart Association grade II or greater congestive heart failure requiring hospitalization within 12 months prior to registration
History of stroke or transient ischemic attack within 3 months prior to registration.
Inadequately controlled hypertension (systolic blood pressure \> 140 mm Hg and/or diastolic blood pressure \> 90 mm Hg despite antihypertensive medication)
History of cerebral vascular accident (CVA) within 3 months prior to registration
Serious and inadequately controlled cardiac arrhythmia
Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection)
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with acquired immunodeficiency syndrome (AIDS) from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
Pregnant or nursing women because of concern of fetal/infant exposure to these agents
Any condition that impairs ability to swallow pills (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, active peptic ulcer disease).
Patients cannot be receiving enzyme-inducing anti-epileptic Drugs (EIAEDs) nor any other Image result for CYP3A4 Cytochrome P450 3A4 (CYP3A4) inducers such as rifampin or St. John's wort beginning at least 14 days prior to registration Step 2.
Patients cannot be receiving CYP3A4 inhibitors beginning at least 7 days prior to registration Step 2.
+2 more criteria

Dose-Dense Temozolomide + Lapatinib for Recurrent Ependymoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Temozolomide + Lapatinib

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Temozolomide + Lapatinib

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Documents

Locations