Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Nervous System Diseases

Carcinoma, Non-Small-Cell Lung

Breast Neoplasms

Neoplasm Metastasis

Lung Neoplasms

Brain Neoplasms

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Trastuzumab

Immunoglobulins

Antineoplastic Agents, Immunological

Trastuzumab will be administered after GRN1005 in patients with HER2+ metastatic breast cancer.

GRN1005 will be administered at a dose of 550 mg/m2 as an IV infusion at a rate of 8.0 - 8.5 mL/minute on Day 1 of 21-day cycle ( 3 days) and a second dose will be given on the day of surgery (day 21) 3-6 h prior to surgery.

GRN 1005

Susan E Bates, M.D.

Background:

- Brain metastases are cancer cells that have spread to the brain from primary cancers in other organs. These tumors can be removed surgically. However, researchers are trying to find better ways to treat brain metastases. A new drug, GRN1005, has been designed to cross into the brain and deliver the cancer treatment drug paclitaxel to treat tumors. Researchers want to see how well GRN1005 works on brain metastases from breast or lung cancer.

Objectives:

- To test the safety and effectiveness of GRN1005 in treating brain metastases from breast or lung cancer.

Eligibility:

- Individuals at least 18 years of age who have breast or lung cancer that has spread to the brain.

Design:

* Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Tumor tissue samples may also be collected. Imaging studies will also be performed.
* Participants who have breast cancer will be divided into two groups. Those whose cancer contains the HER2 protein will be treated with the drug Herceptin as well as GRN1005. Those without HER2 will have only GRN1005.
* Participants who have lung cancer will also have only GRN1005.
* All participants will have two doses of GRN1005, each 3 weeks apart. On the day the second dose of GRN1005 is given, participants will undergo surgery to remove the brain tumors.
* Treatment will be monitored with frequent blood tests and imaging studies.

Background:

Brain metastasis is the most common intra-cranial tumor in adults with approximately 170,000 new cases being diagnosed in the United States annually. The incidence of brain metastasis is increasing. Usually brain metastases of breast cancer occur after the diagnosis of systemic metastases; but approximately 10 25% of patients with lung cancer have brain metastases at diagnosis and another 40 50% develop them during the course of their disease. Multiple factors are contributing to this increase: aging population, improved imaging techniques, and improvement in the treatment of tumors leading to prolonged survival, thereby allowing the emergence of brain metastases, with the brain being generally regarded as a sanctuary site because of the blood brain barrier (BBB). Lung cancer and breast cancer are the leading tumor types, accounting for approximately 50% and 15 - 20% of patients with brain metastases. This study will evaluate the ability of 18F-FLT to determine if amount of change in the uptake in the brain metastases from breast and lung cancer after one dose of therapy with GRN1005, correlates with intra-cranial response. FLT-PET utilizes a radiolabeled form of thymidine, which is incorporated into DNA in proliferating cells. 18F-FLT uptake correlates better than 18F-FDG with proliferation, tumor progression, and survival. Because CNS uptake of FLT is low in contrast to FDG, this makes it potentially useful in evaluating CNS metastases. We would like to see which of these imaging modalities is superior in detection of brain metastases, and monitoring response to therapy.

Objectives:

-Determine whether one cycle of therapy GRN1005 is associated with a change in FLTPET uptake.

Eligibility:

* Adult patients (greater than or equal to 18 years)
* Histologically or cytologically-documented breast cancer (HER2 status must be known) or NSCLC
* Presence of resectable brain metastases based on evaluation by neurosurgery.
* At least one radiologically-confirmed and measurable metastatic brain lesion.

Design:

* Pilot non-randomized trial with or without trastuzumab
* Ten patients with resectable brain metastases from breast cancer and ten patients with resectable brain metastases from NSCLC will be studied.
* Baseline imaging (brain tumor protocol MRI and DSC-PWI MRI, FLT-PET) 1-14 days prior to first dose of GRN1005.
* Patients will receive 1 dose of GRN1005 on day 1 of study.
* Repeat FLT-PET imaging and MRIs will be done after 1 cycle of therapy and prior to surgery, on day 21.
* On the day of surgery, patients will receive a second dose of GRN1005 3 to 6 hours prior to brain surgery.
* PK studies will be done after each dose of GRN1005.
* Optional extra-cranial tumor biopsies will be performed before and after GRN1005 administration.
* Following surgery radiation therapy will be offered to patients as clinically indicated per radiation oncologist s recommendation.

GRN1005 for Brain Metastases From Breast or Lung Cancer

A Pilot Study of GRN1005 for Resectable Brain Metastases in Patients With Breast Cancer and Non-Small Cell Lung Cancer

National Cancer Institute (NCI)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
GRN1005 for Brain Metastases From Breast or Lung Cancer	NCT01679743	Breast Cancer Lung Neoplasms Breast Neoplasm... Lung Cancer	Trastuzumab GRN 1005	18 Years - 99 Years	National Institutes of Health Clinical Center (CC)
GRN1005 for Brain Metastases From Breast or Lung Cancer	NCT01679743	Breast Cancer Lung Neoplasms Breast Neoplasm... Lung Cancer	Trastuzumab GRN 1005	18 Years - 99 Years	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for 18flt

Every month we try and update this database with for 18flt cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for 18flt

Every month we try and update this database with for 18flt cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for 18flt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.