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Old 02-01-2014, 07:18 AM   #1
Mom
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Desperately Seeking Info on IT Herceptin

My daughter is stage iv Her2 positive with brain mets (as well as liver, lung, etc). All but brain seem to be reacting well to various chemos (i.e. tdm-1, Xeloda) but we need to find the best treatment plan for the brain (FAST). I am aware of the IT Herceptin trial at Northwestern University, Chicago (and other locations) but I also feel like there are other facilities (outside the trial) that are administering the Herceptin directly to the brain. She lives in Atlanta so I'm looking for information regarding whether anyone has rec'd IT Herceptin locally in Atlanta or close by. Also just curious about anyone's experience outside of a trial. I spoke to a research nurse at Dana-Farber and she was not aware of IT Herceptin outside of a trial they are doing there (in conjunction with Northwestern U) but I have personal knowledge of a lady getting it at University of Michigan in Ann Arbor and I've seen some other posts here regarding MD Anderson doing it. I am my daughter's best patient advocate (as I've had to find out over the past few years) so any and all information would be greatly appreciated.
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Old 02-01-2014, 09:28 AM   #2
KDR
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Re: Desperately Seeking Info on IT Herceptin

If you haven't connected with Rolepaul, now might be the time. Best of luck, Karen
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World Trade Center Survivor (56th Floor/North Tower): 14 years and still just like yesterday.
Graves Disease, became Euthyroid via Radioactive Iodine, June 2001.
Thyroid Eye Disease. 2003. Decompression surgery in 2009; eyelid lowering surgery in 2010.
Diagnosed: June 2010, liver mets. ER-/PR+10%; HER2+++.
July 2010: Begin Taxol/Herceptin. Eliminate sugar from diet. No surgery or radiation.
January 2011: NED
April 2011: Progression in liver only. Other previous affected areas eradicated. Stop Taxol/Herceptin after 32 infusions.
May 2011: Brain MRI: clear.
May 2011: Begin Tykerb daily, Xeloda twice per day for one week on, one week off, and Herceptin.
November 2011: Progression in liver. All other tumors remain eradicated.
December 2011: BEGIN TRIAL #09-093 Taxol, MCC-DM1 (T-DM1), Perjeta.
Trial requires scans every six weeks, bloodwork and infusions weekly.
Brain MRI: clear.
January 2012: NED. Liver mets, good riddance!
March 2012: NED. Developed SMA (rare blood clot) in intestinal artery and loss of sight in right eye due to optical nerve neuropathy. Resolved when Taxol removed this month.
Continue Protocol of T-DM1 weekly and Perjeta every 3 weeks.
May 2012: NED.
June 2012: Brain MRI: clear.
June-December 2012: NED.
December 2012: TRIAL CONCLUDED; ENTER TRIAL EXTENSION #09-037. CT, Brain MRI, bone scan: clear. NED.
January-March 2013: NED.
June 2013: Brain MRI: clear. CEA upticking; CT shows new met on liver.
July 3, 2013: DISASTER STRIKES during liver ablation: sloppy surgeon cuts intercostal artery and I bleed out, lose 3.5 liters of blood, have major hemothorax, and collapsed lung requiring emergency resuscitative thoracotomy, lung surgery, rib rearrangement and cutting deep connective tissue, transfusion. Ablation incomplete. This life-saving procedure would end up causing me unforgiving pain with every movement I make, permanently, otherwise known as forever.
July 26, 2013: Try Navelbine/Herceptin. Body too weak after surgery and transfusion. Fever. CEA: Normal.
August 16, 2016: second dose Navelbine/Herceptin; CEA: Normal. Will skip doses. Watching and waiting.
September 2013: NED, Herceptin only. CEA: Normal. Started Arimidex.
October-November 2013: NED. Herceptin and Arimidex. CEA, CA125, 15-3: Normal.
December 2013: Something brewing. PET lights up on little spot on liver; CEA upward trend, just outside normal. PET and triphasic liver scan confirm Little Met. Restart Perjeta with Herceptin, stay on Arimidex. Genomic sequencing completed for future treatments, if necessary.
January 2014: Ablate Little Met on the 6th. Happy New Year.
March 2014: Brain MRI: clear. PET/CT reveal liver mets return; new lung mets. This is not funny.
March 2014: BEGIN TRIAL #10-005 A(11)-Temsirolimus plus Neratinib.
April 2014: Genomic testing indicated they could work, they did not. Very strange drug combo for me, felt weird.
April 2014: Started Navelbine and Herceptin. Needed something tried and true, but had significant progression.
June 2014: Doxil and Herceptin.
July 2014: Progression. Got nothing out of it. Brain: NED.
July 2014: Add integrative medical hematologist-oncologist to my team. Begin supplements. These are tumor-busting, immune system boosters. Add glutathione, lysine and taurine IV infusions every three weeks.
July 2014: Begin Gemzar, Herceptin & Perjeta. Happy.
August 2014: ECHO perfect.
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Old 02-01-2014, 11:40 AM   #3
Mom
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Re: Desperately Seeking Info on IT Herceptin

Thank you Karen, yes I considered contacting him as well as Marvass via PM, but was also hoping to hear from others who might be able to shed some light on treatment in the Atlanta area. For such a huge city I'm disappointed by the lack of cancer care/trials available to us here. Or at least, we have not find them if they're out there. I appreciate your input!
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Old 02-01-2014, 02:13 PM   #4
Lani
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Re: Desperately Seeking Info on IT Herceptin

Intrathecal herceptin classically is described as a treatment for leptomeningeal metastases not brain mets.

Has your daughter's CSF (cerebrospinal fluid) been tapped and examined for her2+ malignant cells?

As I understand it, even if a brain met is at/near the periphery of the brain or spinal cord (where the linings that envelope those structures reside) or perhaps within the areas adjacent to where the CSF circulates within the brain, it is not clear that herceptin would be able to get to it if herceptin is injected into the CSF which bathes the outside linings of the brain and spinal cord and the various internal "lakes" within the brain.

The IT herceptin trials cite "leptomeningeal involvement"--concomitant brain mets do not exclude one from the trial but leptomeningeal involvement by MRI and/or malignant cells in CSF are required for participation.
Here is the trial info:
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HomeFind StudiesStudy Record Detail
Intrathecal Trastuzumab for Leptomeningeal Metastases in HER2+ Breast Cancer
This study is currently recruiting participants.
Verified January 2014 by Northwestern University
Sponsor:
Northwestern University
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT01325207
First received: March 7, 2011
Last updated: January 13, 2014
Last verified: January 2014
History of Changes
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
Purpose
The drug being studied is Trastuzumab, a medicine that is used to slow or stop the growth of cancerous tumors that are HER-2 positive. Patients are being asked to participate in this study because they have been diagnosed with having tumor cells in their spinal fluid. This study will investigate the safety and effects of this drug when given directly into the spinal fluid.

Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer The purpose of this research study is to determine a safe dose of the drug Trastuzumab and then determine how effective this treatment is.


Condition Intervention Phase
Breast Cancer
Radiation: Trastuzumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Trastuzumab
U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
Determine the safety and maximum tolerated dose of IT trastuzumab. [ Time Frame: treated twice a week for 4 weeks, then once a week for 4 weeks, and then every 2 weeks ] [ Designated as safety issue: No ]
The initial phase of this study will be a dose escalation trial of 3-6 patients per each dose level. Dose escalation will occur until the MTD or the maximal defined dose (MDD) (40 mg) is reached. The starting dose will be 10 mg for cohort 1, 20 mg for cohort 2, 30 mg for cohort 3 and 40 mg for cohort 4. Patients will be treated twice a week for 4 weeks, then once a week for 4 weeks, and then every 2 weeks. The starting dose is based on the safety of this dose and higher doses as reported in the literature. The MTD or MDD will be used for phase II.


Secondary Outcome Measures:
Determine response to IT trastuzumab: radiological, cytological and clinical. [ Time Frame: A baseline enhanced MRI of the brain and spine within 14 days of registration. The first follow up MRI of the brain and spine will be done after 4 weeks then every 6-8 weeks +/- 3 days for each ] [ Designated as safety issue: No ]
A baseline MRI of the brain and spine within 14 days of registration. Follow up MRI of the brain and spine,at 4 weeks then every 6-8 weeks. CT chest/abdomen/pelvis is optional but will be ordered if needed to assess systemic disease and any response.

Define the CSF PK of IT trastuzumab. [ Time Frame: CSF analysis for cytology will be done every 2 weeks when CSF is obtained for PK and then every 4 weeks ] [ Designated as safety issue: No ]
Patients may need a CSF flow study at the discretion of the treating principal investigator. If a spinal block is seen by CSF flow study or MRI, it will need local RT prior to treatment. Concurrent radiation is not allowed.


Estimated Enrollment: 24
Study Start Date: April 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intravenous trastuzumab infusions
A Phase I single dose study (H0407g) of intravenous trastuzumab infusions ranging from 10-500 mg resulted in dose-dependent pharmacokinetics (PK) with serum clearance of trastuzumab decreasing with an increasing dose at doses <250 mg. PK modeling of trastuzumab concentration-time data from 7 patients that were administered doses of 250 mg and 500 mg had in a mean halflife of 5.8 days (range 1-32 days).
Radiation: Trastuzumab
Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks
Other Names:
(also known as Herceptin, which
is a medicine that is used to slow or stop the growth of a cancerous tumor)

Detailed Description:
Phase I: Patients will be treated in cohorts of 3-6 based on standard phase I dose escalation parameters requiring 0/3 or 1/6 patients per cohort to have a DLT before dose escalation. Dosing is as follows: Cohort 1-10 mg IT, cohort 2-20 mg IT, cohort 3-30 mg IT and cohort 4-40 mg IT. Patients will be treated twice a week for 4 weeks, then once a week for 4 weeks, and then every 2 weeks. Toxicity for DLT will be assessed during first 4 weeks of treatment. Phase II: Patients will be treated with the MTD or maximal defined dose. Patients will be treated twice a week for 4 weeks, then once a week for 4 weeks, and then every 2 weeks.

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:

ELIGIBILITY CRITERIA

HER2 positive (IHC 3+ and/or FISH positive) breast cancer patients with leptomeningeal metastases by MRI or CSF (if MRI is negative). o Review will be performed for cases not reviewed at Northwestern for confirmation, but will not preclude patients from entering the trial (pathology report is sufficient for registration).
Patients can have concomitant brain metastases as long as they do not require active treatment or have been treated.
Patients with leptomeningeal disease from ependymomas, gliomas, and medulloblastoma will be eligible for phase I
Life expectancy > 8 weeks
Normal renal (creatinine < 1.5 ULN), liver (bilirubin < 1.5 x ULN, transaminases < 3.0 x ULN, except in known hepatic metastasis, wherein may be < 5 x ULN) and blood counts (WBC > 3.0, Neutrophils > 1500, platelets >100 000, Hemoglobin > 10).
LVEF > 50%
KPS > 50
Age > 18 years
Cannot be on systemic agents (chemotherapy) that have CNS penetration unless they develop leptomeningeal metastases while on these agent(s) and have controlled systemic disease. May continue on IV trastuzumab, lapatinib or hormonal agents if controlling systemic disease and developed LM while on therapy. Patients requiring systemic chemotherapy are eligible but will not be able to start treatment until after the first assessment by imaging and cytology.
Patients may need a CSF flow study at the discretion of the treating principal investigator. If a spinal block is seen by CSF flow study or MRI, it will need local RT prior to treatment. Concurrent radiation is not allowed.
Patients should be > 2 weeks from RT treatment and all effects of treatment should have resolved
No limit on prior systemic or IT therapies.
CSF sampling to document LM if not documented on MRI.
Must be willing to have an Ommaya reservoir placed.
NO history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless in complete remission and off all therapy for the disease for a minimum of 3 years.
Significant medical or psychiatric illness that would interfere with compliance and ability to tolerate treatment as outlined in the protocol.
Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study.
Women may not be pregnant or breast-feeding.
Ability to sign an informed consent; can be signed by family member or health care proxy. Informed consent must be done prior to registration on study.
All patients must have given signed, informed consent prior to registration on study.
No known hypersensitivity to trial medications Note: The eligibility criteria listed above are interpreted literally and cannot be waived.
Exclusion Criteria:

- Any deviations from the inclusion criteria

Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01325207

Contacts
Contact: Jeffrey Raizer, MD 312-695-0990 Jraizer@nmff.org
Contact: Study Coordinator 312-695-1301 cancertrials@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Nancy Lin, MD nancy_lin@dfci.harvard.edu
Principal Investigator: Nancy Lin, MD
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Elena Pentsova, MD 212-639-7330 omuroa@mskcc.org
Principal Investigator: Elena Pentsova, MD
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Suriya A. Jeyapalan, MD 401-444-6788
Principal Investigator: Suriya A. Jeyapalan, MD
United States, Texas
Texas Oncology-Austin Recruiting
Austin, Texas, United States, 78705
Contact: Morris Groves, MD 512-421-4100
Principal Investigator: Morris D. Groves, M.D.
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Jeffrey Raizer, MD Northwestern University
More Information

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT01325207 History of Changes
Other Study ID Numbers: NU 10C03, STU00040150
Study First Received: March 7, 2011
Last Updated: January 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Meningeal Carcinomatosis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Nervous System Diseases
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 30, 2014

Hope this helps
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Old 02-01-2014, 02:29 PM   #5
Adriana Mangus
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Re: Desperately Seeking Info on IT Herceptin

Hi,

God Bless you for taking care of your daughter. I understand your situation and agree with Karen, Rolepaul is your best shot.

Please keep us posted.

Adriana
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28 nodes neg
Er,Pr, Positive HER2 status unknown
2003- Recur to rt lung.July 16 ( B-Day!)
Her2+++ Er,Pr, Negative
2003 - Aug04--Navelbine + Herceptin
2004- 2007--
NED - Herceptin, only
2007 Feb-April Xeloda added to hereceptin
2007-May Back on Navelbine+Herceptin
2008-Feb-Mar 15 Ses Rad to Rt. Lung
2008- Oc 17 Add Tykerb to Herceptin
2009- June-- Discont Tykerb
2009 July 7--Current Taxol + Herceptin
2009 Dec--Discontinued treatment due to progression. Looking into cyberknife.
2010-Aug Accepted to TDM1, no SE, except liver count went up.
2010-2011 September got kicked out of the trial, due to a small spot found on lung.
2011- 2012 September thru early 2013 on Herceptin
2013- March Bone density shows small spot on 5th rib.
2013 - April 4th appt with onc. will post after discussing course of treatment.
2013-March-April Cyber knife to brain and radiation to rib. Chest --base line before chemo-CT-Scan stable for lung issue. CA2729 Normal.
2013 April Herceptin- TDMI
2013 Sept Herceptin + Perjeta . CA2729 within normal range. Brain and Pet scans October 31st. will post results.
2013 October Brain MRI- mixed response. Will see Onc/rad on Halloween.
2013 October/November Brain-MRI nothing new. Repeat MRI next year in May.

2013 December Continue Herceptin and Perjeta. Stable at the moment.
2014 February Brain MRI -clear!
2014 January Added Taxotere to Perjeta+Herceptin.
2014 March Stopped chemo-chest ct-scan next.

2014- March Scans shows tumor's larger, CA2729 higher. Discontinue Herceptin.
2014 April Perjeta+ Halaven
2014 April CA2729 went down 60 points after one cycle. Cough does not want to go away.
2014 June Continue on Perjeta + Halaven-- no more cough. Stable
2014 June Back on Herceptin + abraxane
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Old 02-01-2014, 02:58 PM   #6
Mom
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Re: Desperately Seeking Info on IT Herceptin

Thank you Lani for the detailed info. From what I can gather, she has parenchymal brain mets with a possibility of now developing the leptomeningeal mets. I guess I was hoping that the IT Herceptin would be a solution for both.
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Old 02-05-2014, 03:25 PM   #7
Jackie07
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Re: Desperately Seeking Info on IT Herceptin

Perhaps you can get some information through the toll-free number provided here: https://winshipcancer.emory.edu/ The navigator there ought to know the best access in Atlanta.
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