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GRN1005 for Brain Metastases From Breast or Lung Cancer

NCT01679743 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-11-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Trastuzumab

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

DRUG

GRN 1005

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Susan E Bates, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-29
Primary Completion
2014-08-11
Completion
2014-08-11

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01679743 on ClinicalTrials.gov