WithdrawnPhase 2

GRN1005 for Brain Metastases From Breast or Lung Cancer

0Started 2012-08-29

Plain-language summary

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.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* INCLUSION CRITERIA: * 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 with or without prior radiotherapy. Patients must be greater than 28 days from WBRT or SRS * Presence of resectable brain metastases, as assessed by neurosurgical evaluation. A brain tumor will be considered to be resectable for the purposes of the study if it is located in the cerebrum or the cerebellum. Tumors that are located in deep brain structures, including the medulla, pons, midbrain, thalamus, and basal ganglia will be considered non-resectable. The tumor must be solitary or, if not, accompanied by another tumor on the same side of the brain that is also considered to be resectable by the same criteria. * At least one radiologically-confirmed and measurable metastatic brain lesion (greater than or equal to 1.0 centimeters in the longest diameter) by Gd-MRI of the brain less than 14 days prior to first dose of GRN1005 (Cycle 1, Day 1). The spatial resolution of the Philips Gemini TOF PET/CT is 4millimeters \[FWHM, (full width half maximum)\]. One cm is greater than 2 times this FWHM and it is anticipated that greater than 70% of the actual activity in the lesion will be visualized (i.e. recovered). It is expected that all lesions greater than or equal to 1 centimeters will have sufficient FLT uptake. If no lesions on the baseline image are visualized on FLT P…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Effect of GRN therapy on PET uptake after treatment cycle 1

Timeframe: 2 years

Trial details

NCT IDNCT01679743

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2014-08-11

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