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Old 08-27-2008, 07:13 AM   #1
Believe51
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Question Joe, Christine or Lani....BRAIN MET CLINICAL TRIALS~ANYWHERE???

Looking for clinical trials for BRAIN METS somewhere close to home but will go anywhere.

Also need to get into Dana Farber again. I will know more after 1:00 today. Need to see Dr Wiener this time, sorry we did not have him in the beginning and I do regret that very very much.

Any sugggestions or thoughts??>>Believe51
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9/7/06Husband 50yrs=StageIV IBC/HER2+,BoneMets10/06TaxotereX10,'H'1X wk,Zometa,Tamoxifen4/12/07Last Tax5/18/07Pet=Rapid Cell Activity,No Organ Mets,Lytic Lesions,Degeneration,Some Bone Repair5/07ChemoFail6/01/07Pleural Thoracentisis=Effusions,NoMalignantCells6/19/07+7/2/07DFCI
6/25/07BrainMRI=BrainMets,Many<9mm7/10/07WBR/PelvisRad37.5Gx15&Nutritionist8/19/07T/X9/20/07BrainMRI=2<2mm10/6/07Pet=BoneProgression
10/24/07ChemoFail11/9/07A/Cx10,EndTam12/7/07Faslodex12/10/07Muga7512/13/07BlasticLesions1/7/08BrainMRI=Clear4/1/08Pet=BoneImprovement,
NoProgression,Stable4/7/08BrainPerfect5/16/08Last A/C8/26/08BrainMets=10(<9mm)9/10/08Gamma10/30/08Met=5mm12/19/08Gamma5mets5
12/22/08SpinalMets1/14/09SpinalRads2/17/09BrainMRI=NoNewMets4/20/09BoneScan5/14/09Ixempra6/1/09BrainMRI=NumerousMets6/24/09DFCIw/DrBurstein6/26/09Continue
Ixempra/Faslodex/Zometa~TM now lower7/17/09Stop Ixempra By Choice9/21/09HOSPICE10/16/09Earned His Deserved Wings And Halo=37 Month Fight w/Stage 4 IBC, Her2+++,My Hero!!
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Old 08-27-2008, 10:10 AM   #2
hutchibk
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Eric Winer is the way to go, Marie. I talked to him at SABCS last December and he is a gem! If anyone knows brain mets trials, he would be the one. And he might even have some himself. Also, you might contact Kent Osborne at Baylor College of Medicine Breast Center in Houston. He or his other docs may have something cooking. But, I just don't know if you need anything experimental just yet - as there are so many very solid options available that are working wonderfully for many of us!
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Brenda

NOV 2012 - 9 yr anniversary
JULY 2012 - 7 yr anniversary stage IV (of 50...)

Nov'03~ dX stage 2B
Dec'03~
Rt side mastectomy, Her2+, ER/PR+, 10 nodes out, one node positive
Jan'04~
Taxotere/Adria/Cytoxan x 6, NED, no Rads, Tamox. 1 year, Arimadex 3 mo., NED 14 mo.
Sept'05~
micro mets lungs/chest nodes/underarm node, Switched to Aromasin, T/C/H x 7, NED 6 months - Herceptin only
Aug'06~
micro mets chest nodes, & bone spot @ C3 neck, Added Taxol to Herceptin
Feb'07~ Genetic testing, BRCA 1&2 neg

Apr'07~
MRI - two 9mm brain mets & 5 punctates, new left chest met, & small increase of bone spot C3 neck, Stopped Aromasin
May'07~
Started Tykerb/Xeloda, no WBR for now
June'07~
MRI - stable brain mets, no new mets, 9mm spots less enhanced, CA15.3 down 45.5 to 9.3 in 10 wks, Ty/Xel working magic!
Aug'07~
MRI - brain mets shrunk half, NO NEW BRAIN METS!!, TMs stable @ 9.2
Oct'07~
PET/CT & MRI show NED
Apr'08~
scans still show NED in the head, small bone spot on right iliac crest (rear pelvic bone)
Sept'08~
MRI shows activity in brain mets, completed 5 fractions/5 consecutive days of IMRT to zap the pesky buggers
Oct'08~
dropped Xeloda, switched to tri-weekly Herceptin in combo with Tykerb, extend to tri-monthly Zometa infusion
Dec'08~
Brain MRI- 4 spots reduced to punctate size, large spot shrunk by 3mm, CT of torso clear/pelvis spot stable
June'09~
new 3-4mm left cerrebellar spot zapped with IMRT targeted rads
Sept'09~
new 6mm & 1 cm spots in pituitary/optic chiasm area. Rx= 25 days of 3D conformal fractionated targeted IMRT to the tumors.
Oct'09~
25 days of low dose 3D conformal fractionated targeted IMRT to the bone mets spot on rt. iliac crest that have been watching for 2 years. Added daily Aromasin back into treatment regimen.
Apr'10~ Brain MRI clear! But, see new small spot on adrenal gland. Change from Aromasin back to Tamoxifen.
June'10~ Tumor markers (CA15.3) dropped from 37 to 23 after one month on Tamoxifen. Continue to monitor adrenal gland spot. Remain on Tykerb/Herceptin/Tamoxifen.
Nov'10~ Radiate positive mediastinal node that was pressing on recurrent laryngeal nerve, causing paralyzed larynx and a funny voice.
Jan'11~ MRI shows possible activity or perhaps just scar tissue/necrotic increase on 3 previously treated brain spots and a pituitary spot. 5 days of IMRT on 4 spots.
Feb'11~ Enrolled in T-DM1 EAP in Denver, first treatment March 25, 2011.
Mar'11~ Finally started T-DM1 EAP in Denver at Rocky Mountain Cancer Center/Rose on Mar. 25... hallelujah.

"I would rather be anecdotally alive than statistically dead."
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Old 08-27-2008, 11:26 AM   #3
schoonder
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Believe51

I searched clinicaltrials.gov registry using search keys brain and her2 and found following six active trials.
Use of other search keys, like brain and met will probably result in other trials. I hope that this helps.
http://www.clinicaltrials.gov/ct2/re...her2&recr=Open
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Old 08-27-2008, 11:34 AM   #4
Lani
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I did a quick search of clinical trials and

of the one with WBR or SBR--they only allowed 1-3 brain mets

Another was for lapatinib after failure of WBR or SBR

I didn't get a chance yet for a full review but thought of Dr. Wicha of Michigans new gamma secretase inhibitor trial against cancer stem cells as the gamma secretase inhibitors have been investigated for Alzheimers and must therefore cross the blood brain barrier.

So for I just found this notch inhibitor trial, but will get back on the web later and try to find Dr. Wicha (of U of Michigan)'s trial

Here is the notch inhibitor--don't know if it crosses the blood-brain barrier--
and unfortunately it is only Phase I--will keep looking

A Notch Signalling Pathway Inhibitor for Patients With Advanced Breast Cancer
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs



Phase I


Treatment


Active


18 and over


Pharmaceutical / Industry


2005_008
MK0752-014, NCT00106145


Trial Description


Summary

An investigational study to determine the safety/tolerability, and efficacy of a notch signaling pathway inhibitor in patients with metastatic or locally advanced breast cancer and other advanced solid tumors.

Eligibility Criteria

Inclusion Criteria:

Women or men greater than or equal to 18 years of age
ECOG status less than or equal to 2 (a measurement to determine your ability to perform daily activities)
In Part I of the study, patients must have metastatic or locally advanced breast cancer or other solid tumors, and have failed at least one prior systemic therapy.
In Part II of the study, patients must have metastatic or locally advanced breast cancer.
Exclusion Criteria:

Patient has had an investigational treatment in the preceding 30 days
Uncontrolled congestive heart failure or myocardial infarction (heart attack) within 3 months of study start
History of hepatitis B or C or HIV
Trial Contact Information


Trial Lead Organizations/Sponsors

Merck and Company, Incorporated

Medical Monitor Study Director

Toll Free Number Ph: 1-888-577-8839

Trial Sites

U.S.A.

Colorado

Denver

Call for Information
Florida

Tampa

Call for Information
Massachusetts

Boston

Call for Information
Michigan

Detroit

Call for Information
New York

Troy

Call for Information
Texas

Austin

Call for Information
Bedford

Call for Information
Dallas

Call for Information
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00106145
Information obtained from ClinicalTrials.gov on August 15, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials.
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Old 08-27-2008, 11:37 AM   #5
Joe
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Trials specific to Dana Farber:

http://www.clinicaltrials.gov/ct2/re...ND+dana+farber

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Old 08-27-2008, 11:45 AM   #6
Lani
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you might email this gentlemen re whether there are trials

1: J Neurooncol. 2006 Sep 26; [Epub ahead of print] Links
A lipoxygenase inhibitor in breast cancer brain metastases.

Flavin DF.
Foundation for Collaborative Medicine and Research, 24 Midwood Drive, Greenwich, CT, 06831, USA, Dana_FK@hotmail.com.
The complication of multiple brain metastases in breast cancer patients is a life threatening condition with limited success following standard therapies. The arachidonate lipoxygenase pathway appears to play a role in brain tumor growth as well as inhibition of apoptosis in in-vitro studies. The down regulation of these arachidonate lipoxygenase growth stimulating products therefore appeared to be a worthwile consideration for testing in brain metastases not responding to standard therapy. Boswellia serrata, a lipoxygenase inhibitor was applied for this inhibition. Multiple brain metastases were successfully reversed using this method in a breast cancer patient who had not shown improvement after standard therapy. The results suggest a potential new area of therapy for breast cancer patients with brain metastases that may be useful as an adjuvant to our standard therapy.
PMID: 17001517 [PubMed - as supplied by publisher]
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Old 08-28-2008, 08:54 AM   #7
Believe51
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Thumbs up Whew!

You guys are the best, looks like no xanax for me today, I will be too busy investigating options. Oh...and Lani..looks like Santa came early this year..LOL>>Believe51
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9/7/06Husband 50yrs=StageIV IBC/HER2+,BoneMets10/06TaxotereX10,'H'1X wk,Zometa,Tamoxifen4/12/07Last Tax5/18/07Pet=Rapid Cell Activity,No Organ Mets,Lytic Lesions,Degeneration,Some Bone Repair5/07ChemoFail6/01/07Pleural Thoracentisis=Effusions,NoMalignantCells6/19/07+7/2/07DFCI
6/25/07BrainMRI=BrainMets,Many<9mm7/10/07WBR/PelvisRad37.5Gx15&Nutritionist8/19/07T/X9/20/07BrainMRI=2<2mm10/6/07Pet=BoneProgression
10/24/07ChemoFail11/9/07A/Cx10,EndTam12/7/07Faslodex12/10/07Muga7512/13/07BlasticLesions1/7/08BrainMRI=Clear4/1/08Pet=BoneImprovement,
NoProgression,Stable4/7/08BrainPerfect5/16/08Last A/C8/26/08BrainMets=10(<9mm)9/10/08Gamma10/30/08Met=5mm12/19/08Gamma5mets5
12/22/08SpinalMets1/14/09SpinalRads2/17/09BrainMRI=NoNewMets4/20/09BoneScan5/14/09Ixempra6/1/09BrainMRI=NumerousMets6/24/09DFCIw/DrBurstein6/26/09Continue
Ixempra/Faslodex/Zometa~TM now lower7/17/09Stop Ixempra By Choice9/21/09HOSPICE10/16/09Earned His Deserved Wings And Halo=37 Month Fight w/Stage 4 IBC, Her2+++,My Hero!!
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