Neoplasms

All Conditions

Nervous System Diseases

Rare Diseases

Glioma

Brain Neoplasms

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

tablets of 25 mg, 100 mg and 150 mg 75 to 150 mg/m² Once daily

Tarceva (Erlotinib Hydrochloride)

Vassal Gilles, Pr.

The purpose of this study is to establish the recommended dose/Maximum Tolerated Dose (MTD) of Tarceva in children as single agent and in combination with radiation therapy

Prognosis in relapsing malignant brain tumors is poor. Those in brain stem gliomas is dismal; median survival of these children does not exceed 9 months. Radiation therapy may result in early and transient amelioration of symptoms, but have not contributed to increase or prolong survival. Moreover, chemotherapy has not increased this outcome to date.Prados et al. reported encouraging results from a phase I study of TarcevaTM/OSI-774 alone or with temozolomide (TMZ) in patients with malignant gliomas. Of 25 evaluated patients, 6 experienced PR: 4 GBM (glioblastoma multiforme) and 1 grade 3 astrocytoma treated with TarcevaTM alone, 1 GBM treated with TarcevaTM/TMZ; 2 had minor responses, and 3 stable diseases. These results in malignant glioma and the lack of efficacy in brain stem glioma with current treatment suggests the evaluation of this new therapeutic agent in children with relapsed brain tumors and upfront at diagnosis in brain stem glioma in combination with radiation therapy.

Safety Study of Tarceva in Children With Refractory and Relapsed Malignant Brain Tumors and Newly Diagnosed Brain Stem Glioma

Phase I Studies of TarcevaTM (Erlotinib Hydrochloride, OSI-774) as Single Agent in Children With Refractory and Relapsed Malignant Brain Tumors and in Combination With Irradiation in Newly Diagnosed Brain Stem Glioma

Gustave Roussy, Cancer Campus, Grand Paris

Geoerger Birgit/Coordinating Physician

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Tarceva (Erlotinib hydrochloride) + Radiation Therapy. Tarceva 150 mg by mouth every day beginning Day 1. Whole Brain Radiation Therapy (WBRT) for total dose of 3500cGy in 14 daily fractions beginning after Day 6.

150 mg by mouth every day beginning Day 1.

Tarceva (Erlotinib hydrochloride)

Whole Brain Radiation Therapy (WBRT) for total dose of 3500cGy in 14 daily fractions beginning after Day 6.

Radiation Therapy

James Welsh, MD

The goal of this clinical research study is to learn whether Tarceva (erlotinib hydrochloride), when given in addition to whole brain radiation therapy, is better to treat brain metastases in patients with Non-Small Cell Lung Cancer (NSCLC).

The Study Drugs:

Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells that may control tumor growth and survival. This may stop tumors from growing.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will take the study drug on Days 1-6 before receiving radiation therapy. You will take 1 pill each day at least 1 hour before or 2 hours after eating. You will take the study drug while you are receiving radiation therapy. You will continue to take the study drug daily after the radiation therapy is complete for as long as the study doctor thinks it is necessary.

You will record at what time each day you take the study drug on a calendar that the will be provided to you. You will bring this calendar with you to each of your study visits.

During the time you are taking the study drug, you must tell the research staff if you have any changes in the drugs that you are taking. If you feel you are having any problems from the study drug before starting radiation therapy, you must tell the study doctor right away.

Radiation Therapy:

After Day 6 of taking the study drug, you will begin radiation therapy. You will receive radiation therapy 1 time each day (Monday through Fridays only) for a total of 14 days.

Once a week during radiation therapy:

* You will have a physical exam.
* You will complete a quality of life questionnaire (at the last week visit)
* You will complete a mini-mental status exam (at the last week visit)
* You will be asked about any changes in the drugs you may be taking
* You will be asked about how you are feeling and any side effects that you may be having
* You will have blood drawn (about 1/2 teaspoon) for lab tests if necessary.

One month after Radiation therapy follow up:

* You will have a follow up visit 1 month after radiation therapy is complete. The study doctor will decide if you will continue to take the study drug at the follow-up visit. The following tests and procedures will be performed:
* You will have a physical exam.
* You will have an MRI or CT of the brain.
* Your vital signs will be recorded.
* You will complete a quality of life questionnaire.
* You will complete a mini-mental status exam.
* You will be asked about any changes in the drugs you may be taking.
* You will be asked about how you are feeling and any side effects that you may be having.
* You will have blood drawn (about 1/2 teaspoon) for lab tests if necessary.

Follow-up Visits (While on Tarceva):

If, at the end-of-study visit, the doctor decides that you will continue to take the study drug, you will have a follow-up visit with the research nurse 1 time each month. At these visits, the following tests and procedures will be performed:

(If unable to return to MDACC, this visit will be conducted over the telephone and arrangements will be made to mail study Tarceva medication.)

* Your medical history will be reviewed.
* You will receive a 30-day supply of the study drug.
* You will bring in your study drug calendar for the nurse to review.
* You will be asked about how you are feeling and any side effects that you may be having.
* You will also be asked about any changes in the drugs you may be taking.
* Blood (about 1/2 teaspoon) may be drawn for routine tests.

The following tests and procedures will be performed every 3 months:

* You will have a physical exam.
* You will have an MRI or CT of the brain
* Your vital signs will be recorded.

Follow up visit (Discontinuation of Study Drug):

You will have a follow up visit with the research nurse 1 month after your last dose of the study drug, and the following will be performed:

(If unable to return to MDACC, this visit will be conducted over the telephone and arrangements will be made to have the study Tarceva medication and medication diary returned by mail.)

* Your medical history will be reviewed.
* You will be asked about how you are feeling and any side effects that you may be having.
* You will return your study drug calendar and any remaining Tarceva tablets to the research nurse.
* You will also be asked about any changes in the drug you may be taking
* Your vital signs will be recorded.

The following tests and procedures will be performed every 3 months (off Tarceva) for the first 2 years then every 6 months thereafter:

* You will have a physical exam.
* Your medical history will be reviewed.
* You will have an MRI or CT of the brain
* If you are unable to return for your follow up visits due to physical conditions, you will be contacted by phone.

Duration of Study Treatment:

You will remain on study for as long as the study doctor thinks you are benefitting from the study drug. You will be taken off study treatment early if the disease gets worse, you experience intolerable side effects, or your doctor thinks that it is no longer in your best interest to continue to receive treatment on this study.

This is an investigational study. Erlotinib hydrochloride is FDA approved and commercially available. It has not been FDA approved to treat NSCLC that has spread to the brain.

Up to 20 patients will take part in this study. All will be enrolled at MD Anderson.

Tarceva With Whole Brain Radiation Therapy - Brain Mets From Non-Small Cell Lung Cancer

A Phase II Study to Determine the Efficacy of Tarceva® (Erlotinib Hydrochloride) With Concurrent Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer (NSCLC)

Median Survival will be estimated using the method of Kaplan and Meier (1958) using the intent-to-treat principle.

Overall Survival will be estimated using the method of Kaplan and Meier (1958) using the intent-to-treat principle. The participants overall survival measured at 6 month, 1-year and 2 years.

OSI Pharmaceuticals

M.D. Anderson Cancer Center

Patients were treated with Tarceva 150mg PO daily. On day 7, whole brain radiation 3000cGy/10. remained on Tarceva until disease progression/toxicity

Phase II Tarceva for Brain Metastases in NSCLC

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Mexico

Region of Enrollment

KPS≥ 80

KPS≤ 70

The KPS ranking runs from 100 to 0, where 80: Normal activity with effort; some signs or symptoms of disease. 70: Cares for self; unable to carry on normal activity or to do active work. The KPS was to allow physicians to evaluate a patient's survival. The higher KPS scores, the better treatment outcome.

Karnofsky Performance Score (KPS)

Adenocarcinoma

Other

Squamous

Tumor Histology

Never

Prior

Current

Unknown

Smoking History

Previous Therapy

4 -10

Number of Brain Metastases

43 out of 44 patients was were consented and treated under this protocol. 1 patients withdrew consent prior to protocol treatment.

James Welsh,MD- Associate Professor, Radiation Oncology Department

Twenty patients from University of Arizona and 20 patients at MDACC for a total of 40 patients were combined for statistical analysis for Median Survival. We excluded 4 MDACC patients because: 1 patients withdrew consent prior to protocol treatment, I patient death during radiotherapy, 2 patients early death without follow-up data.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety Study of Tarceva in Children With Refractory and Relapsed Malignant Brain Tumors and Newly Diagnosed Brain Stem Glioma	NCT00418327	Malignant Brain... Brain Stem Glio...	Tarceva (Erloti...	1 Year - 21 Years	Gustave Roussy, Cancer Campus, Grand Paris
Tarceva With Whole Brain Radiation Therapy - Brain Mets From Non-Small Cell Lung Cancer	NCT00871923	Non-small Cell ... Brain Cancer	Tarceva (Erloti... Radiation Thera...	18 Years - 70 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for tarceva (erlotinib hydrochloride)