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stimuvax trials


RandyW

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Here's the link: http://www.targetedtherapies.org/rdt1_5.html

-click on the hyperlink to launch presentation

Let's Review Dr. Butts presentation.

Slide 16 Final Analysis

The vaccine arm: 11/2005 survival data at 30.6 months, median survival milestone is reached (18 deaths=51%).

Looks like a death at 46 months and another at 53 months

Stage IIIB subgroup n=65

vaccine arm = 35 patients, Control arm = 30

Looks like 14 of the 35 patients (40%)in the vaccine are are still alive at 64 months.....WOW!

The actual survival calculation was in fact better because survival was calculated at the start of randomization. The true baseline can be argued to be at the actual beginning of therapy!......WOW!

Study might be optomized futher with repeated use of cyclophosamide!.....WOW!

P value was actually .049 at end of study.....WOW!

EXTRA BONUS: Stage IIIA is included in protocol, IV excluded, 3 month window on randomization. Gender balance more evenly weighted in phase III......WOW

Why won't the FDA allow patients access to this Drug when it has shown in every trial to be perfectly safe with little or no side affects????????????????

Those who are suffering deserve access on a humanitarian basis.

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RandyW

MODERATOR

Joined: 27 Jan 2005

Posts: 3242

Location: Greensboro North Carolina

Posted: Thu Nov 16, 2006 8:14 pm Post subject:

THANK YOU FOR THIS

_________________

april/03 Diagnosed adenocarcinoma NSCLC

1/20/2006 Admitted to hospital Respiratory distress

1/23/2006 Ran to the light and is waiting for us to be rejoined in the Kingdom Of Heaven Her journey is Over but mine lingers on for Now!!!

"Life Isn't always beautiful, But it's a beautiful ride" Gary Allen

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karen335

Senior Member

Joined: 28 May 2003

Posts: 2675

Location: Corona, California

Posted: Fri Nov 17, 2006 5:43 pm Post subject:

Thanks Kim...

_________________

God Bless and Praying for a "Cure" for all of us.

<*}}}><

By His stripes, I am healed, I claim His healing

I believe in "Miracles"

Dx'd 3-03, nsclc 3a-b

Radiation 3-25-03 to 5-15-03 (3 treatments

Taxol/carbo 4-1-03 to 5-20-03

Taxol/carbo 7-23-03 to 10-27-03 (every 3 wks)

Pneumonia 9-16-03 in Hosp 4 days

Bronc 10-16 - Pulm Doc can't find tumor & NED

Biopsy 10-16 - test back "NEGATIVE"

Last chemo 10-27-03, PET looks good

CEA <.5 Nov .6 in Jan .9 in March.6 April .7 July

CT & MRI March 04, one 1" tumor brain. Surgery 4-6-04 remove brain tumor successful, cured - Rad Stereotactic 4-04 - NOT WBR

Possible radiation Necrosis 11-05

PET/CT Cking for Necrosis

New pic is Bob & I @ X-mas party 12-13-03

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klmline

Joined: 05 Mar 2006

Posts: 12

Posted: Sat Dec 09, 2006 12:32 am Post subject: Started

http://www.clinicaltrials.gov/ct/show/N ... 88?order=1

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Jyoung20

MODERATOR

Joined: 07 Aug 2005

Posts: 1684

Location: Memphis

Posted: Sat Dec 09, 2006 7:15 am Post subject:

Thanks Kim

_________________

Age 35 at diagnosis

Dx December 2004 Stage IIIB

Started Tarceva June 2005(working)

Stable scans (8/2005)

Stable scans (10/2005)

Stable scans (11/2005)

Celebrating 1 year since diagnosis

1/16/06 NED--just scar tissue and/or fibrosis

4/16/06 NED--just scar tissue and/or fibrosis

7/19/06 Stability again--Thank you Lord Jesus!!

11/19/06 NED

1/19/07 NED Again!!!

4/19/07 NED Again!! God is Good!

Pic of my and my little one on a ferris wheel

www.caringbridge.org/tn/jamie

www.lungevity.org/playingforacure

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klmline

Joined: 05 Mar 2006

Posts: 12

Posted: Mon Dec 18, 2006 11:04 pm Post subject: How to participate

Patients interested in potentially participating in the upcoming Phase 3 study of Stimuvax® should contact EMD Pharmaceuticals toll free at 866-363-4543 or visit their Web site for additional information (www.emdpharmaceuticals.com).

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Joe B

OVER 500 POSTS !

Joined: 22 Nov 2003

Posts: 672

Location: Fenton, Michigan

Posted: Tue Dec 19, 2006 2:41 am Post subject:

this is very, very, very good news.....

_________________

Stage IIIA NSCLC (w/ prominent BAC)

45 year old - NEVER SMOKER

10/2/03 - lobectomy RML (same ann. date as Lance Armstrong)

2.8 CM tumor ; 1 (out of 7) lymph node positive

11/10/03- Concurrent Chemo/ Radiation (cisplatin/etoposide- 28 rad txs) -finished 12/22.

1/5/04 completed adjunctive tx w/ x3 Taxotere (q 3 weeks)- Finished 2/16/04

5/21/04 Radiation Changes in R Lung-

7/6/04- No evidence of Disease

10/8/04 No evidence of Disease

1/11/05 No evidence of Disease

4/14/05 No evidence of Disease

7/8/05 No evidence of Disease

10/4/05 tiny nodules mentioned (3mm,3mm,4mm)

1/9/06 numerous nodules both lungs all small (2mm-5mm)

5/20/06 slight progression rescan in 5 months

10/28/06 MRI Reveal single Brain Met

Surgically removed on 11/9/06

Started Tarceva 2/15/07

-------------------------------------------------------

Husband to my "twin soul", Gina

Father of 3 great daughters (Aly-19, Hannah- 17, Miranda- 15)

-------------------------------------------------------

Romans 10:9 - "That if thou shalt confess with thy mouth the Lord Jesus, and shalt believe in thine heart that God hath raised him from the dead, thou shalt be saved."

John 3:16,17 - "For God so loved the world, that he gave his only begotten Son, that whosoever believeth in him should not perish, but have everlasting life. 17 For God sent not his Son into the world to condemn the world; but that the world through him might be saved "

Revelation 21:4 "And God shall wipe away all tears from their eyes; and there shall be no more death, neither sorrow, nor crying, neither shall there be any more pain: for the former things are passed away."

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tkelley

Over 100 Posts!

Joined: 08 May 2006

Posts: 158

Posted: Tue Dec 19, 2006 2:53 am Post subject:

Thanks KIm

_________________

7/2002 (60 yrs. old) Dad dx laryngeal cancer

8/2002 Laryngectomy and Radical Neck Dissection (only 1 lymph node involved) with follow up radiation treatments (Johns Hopkins)

Clean until 6/2004 spot on lung found by x-ray and CT scan

7/2004 Biopsy shows NSCLC (SCC)

8/2004 Successful Lobectomy of middle right lobe and slight wedge resection of upper right lobe (1 lymph node in removed lobe came back positive) (Johns Hopkins) Drs. feel that it is a new primary cancer.

9/04 started clinical trial of taxotere and cisplatin

12/04 New spot found on CT and PET (lymph node) Bronchoscopy not successful stopping clinical trial

1/05 Started 6 weeks of daily radiation and one time a week regimen (for 6 weeks) of carbo/taxol

2/17/05 Finished with rounds of treatment!

3/30/05 Great news, spot on CT has shrunk from 2.5 cm. to less than 1cm. No new spots, STABLE!

7/05 Angiogram, stent put in, doing great!

7/05 The beast is back in the other lung, 9mm spot top of lung, currently waiting to do treatment due to heart medication (Plavix), will do PET in September to confirm cancer and then make treatment decisions.

9/05 PET revealed that spot doubled in size and there is fluid in other lung. Waiting on thorocentesis and hopefully surgery.

10/05 Heart attack from stopping Plavix for lung procedures.

11/05 Fluid gone Cleared for surgery, scheduled for December 5th

12/05 After a successful lobectomy, had another heart attack while in hospital, pacemaker put in, long road to recovery. Pathology report came back with lymph node involvement, restaged to stage III.

2/06 Scans performed NO EVIDENCE OF ACTIVE DISEASE!! Started Tarceva

5/06 NED!!! Will continue on Tarceva

8/06 NED!!! Tarceva still working!

12/06 Its Back 2cm spot found in mediastinum area between the lungs, doctors believe it is a node.Off Tarceva and on to Alimta right after Christmas.

3/07 STABLE after 3 rounds of Alimta! Starting another three and then scans in May.

*Avatar Picture is of dad at my brother's wedding in September Picture below is of my two children, Connor and Erin

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klmline

Joined: 05 Mar 2006

Posts: 12

Posted: Fri Dec 22, 2006 10:59 pm Post subject: Trial is now recruiting

The trial is now recruiting patients

http://www.clinicaltrials.gov/ct/show/N ... 88?order=1

Trial has a completion date of Dec. 2008. Very odd that a multi national Phase III trial could recruit 1322 patients and be slated for completion within two years. Does anyone here know something that I don't about this trial?

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RandyW

MODERATOR

Joined: 27 Jan 2005

Posts: 3242

Location: Greensboro North Carolina

Posted: Fri Jan 19, 2007 5:45 am Post subject:

This article is part of a press release and the Trial is slated for over 30 countries including UK. THIS IS Very promising providing they can recruit the much needed required patients.

The drug, called Stimuvax, is a type of therapeutic vaccine that targets a specific protein found in many tumours, including non-small cell lung cancer. It was developed by Canadian biotech company Biomira following Cancer Research UK-funded studies led by Professor Joyce Taylor-Papadimitriou of Guy's Hospital, London. Biomira have already run phase II trials with very encouraging results.

The international phase III trial, named START (Stimulating Targeted Antigenic Responses To NSCLC), is expected to enrol its first patient this month. Run by pharmaceutical company Merck KGaA, it will eventually include more than 1,300 lung cancer patients in 30 countries, including the UK.

Therapeutic vaccines are a relatively new development in cancer treatment. Unlike preventative vaccines, they are treatments that induce the body's own immune system to identify and kill existing cancer cells. Stimuvax is designed to stimulate the immune system to recognise and react to a molecule called MUC1, which is much more abundant on tumour cells than healthy cells. The immune system then kills the cancer cells with MUC1, hopefully without overly harming healthy cells.

Cancer Research Technology Limited (CRT), Cancer Research UK's development and commercialisation company, licensed a number of discoveries to Biomira, which led to the development of Stimuvax for advanced non small cell lung cancer. Merck KGaA also plans to investigate the use of Stimuvax for other types of cancer.

Dr Keith Blundy, chief operating officer of CRT, said: "We are extremely pleased that Stimuvax has entered the final stage of clinical trials. The drug is one of CRT's portfolio of more than 20 partnered agents in clinical development. Targeted vaccines are an exciting approach that could potentially offer new treatment options for major types of cancer."

_________________

april/03 Diagnosed adenocarcinoma NSCLC

1/20/2006 Admitted to hospital Respiratory distress

1/23/2006 Ran to the light and is waiting for us to be rejoined in the Kingdom Of Heaven Her journey is Over but mine lingers on for Now!!!

"Life Isn't always beautiful, But it's a beautiful ride" Gary Allen

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Jyoung20

MODERATOR

Joined: 07 Aug 2005

Posts: 1684

Location: Memphis

Posted: Fri Jan 19, 2007 8:07 am Post subject:

Awesome!!

_________________

Age 35 at diagnosis

Dx December 2004 Stage IIIB

Started Tarceva June 2005(working)

Stable scans (8/2005)

Stable scans (10/2005)

Stable scans (11/2005)

Celebrating 1 year since diagnosis

1/16/06 NED--just scar tissue and/or fibrosis

4/16/06 NED--just scar tissue and/or fibrosis

7/19/06 Stability again--Thank you Lord Jesus!!

11/19/06 NED

1/19/07 NED Again!!!

4/19/07 NED Again!! God is Good!

Pic of my and my little one on a ferris wheel

www.caringbridge.org/tn/jamie

www.lungevity.org/playingforacure

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klmline

Joined: 05 Mar 2006

Posts: 12

Posted: Mon Feb 26, 2007 9:56 am Post subject: Stimuvax Cancer Vaccine Phase III Study Begins

http://biz.yahoo.com/prnews/070226/to345.html?.v=13

Anyone here lucky enough to get in?

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RandyW

MODERATOR

Joined: 27 Jan 2005

Posts: 3242

Location: Greensboro North Carolina

Posted: Tue Feb 27, 2007 6:24 am Post subject:

DARMSTADT, Germany, Feb. 26 /PRNewswire/ -- Merck KGaA today announced that the first patient has been enrolled in its global Phase III clinical study, START (Stimulating Targeted Antigenic Responses To NSCLC), assessing the efficacy and safety of Stimuvax (BLP25 liposome vaccine) as a potential treatment for patients with unresectable stage III non-small cell lung cancer (NSCLC).

Enrollment in the study, which will involve more than 1,300 patients in approximately 30 countries, is now open to patients in the U.S. where the first randomization has occurred. Enrollment will subsequently expand to additional countries. Currently, there are no approved maintenance therapies for patients responding to first-line treatment for unresectable stage III NSCLC.

"Patients with advanced lung cancer are in need of new therapies that effectively target cancer cells while providing better safety and tolerability," said Dr. Frances Shepherd, Director of Medical Oncology at Princess Margaret Hospital in Toronto, Ontario and lead investigator of the START study. "Novel therapeutic vaccines such as Stimuvax may help the body's immune system identify and destroy cancer cells without targeting normal, healthy cells."

Lung cancer is the leading cause of cancer-related deaths in both men and women worldwide with approximately 80 percent of cases classified as NSCLC. Further, only about 15 percent of people diagnosed with NSCLC survive this disease after five years.(1) For most patients with NSCLC, current treatments provide limited success.

"The START study is the first Phase III program to evaluate a cancer vaccine in unresectable stage III non-small cell lung cancer and marks an important milestone for the company in its growing oncology business," said Dr. Wolfgang Wein, Senior Executive Vice President, Oncology, Merck Serono. "Our continued investment in research reflects our confidence in Stimuvax and commitment to developing innovative targeted therapies to advance treatment options for patients with cancer."

The START study is a randomized, double-blind, placebo-controlled study that will evaluate patients with documented unresectable stage III NSCLC who have had a response or stable disease after at least two cycles of platinum-based chemo-radiotherapy. The study has been designed considering scientific advice from the European Medicines Agency (EMEA/CHMP) and has been agreed upon with the U.S. Food and Drug Administration (FDA) through a Special Protocol Assessment (SPA). Data from a randomized phase IIb study encouraged the initiation of the Phase III program.

For more information on the START study, or to find a participating center and eligibility criteria, go to http://www.nsclcstudy.com/. The study is also listed on http://www.clinicaltrials.gov/.

Notes for editors

About Stimuvax

Stimuvax is an innovative cancer vaccine designed to induce an immune response to cancer cells that express MUC1, a protein antigen widely expressed on common cancers. MUC1 is over expressed on many cancers such as lung cancer, breast cancer and colorectal cancer. Stimuvax is thought to work by stimulating the body's immune system to identify and destroy cancer cells expressing MUC1.

A randomized Phase IIb study was conducted in 171 patients with stage IIIb and IV NSCLC with response or stable disease after first line therapy. While the overall study results were not statistically significant, in the randomization stratum of patients with stage IIIb locoregional disease, Stimuvax showed a median survival of 30.6 months versus 13.3 months in the control group -- an improvement of 17.3 months. In the Phase IIb study, side effects were primarily limited to mild-to-moderate flu-like symptoms, GI disturbances, and mild injection site reactions.

About Merck KGaA

Merck KGaA is investigating the use of Stimuvax® (BLP25 Liposome Vaccine) in the treatment of non-small cell lung cancer. The vaccine was granted fast-track status in September 2004 by the FDA. Merck obtained the exclusive worldwide licensing rights from Biomira Inc. of Edmonton, Alberta, Canada, with the exception of Canada where the companies will share rights. Stimuvax is being developed in Europe by Merck KGaA and in the United States by its affiliate, EMD Serono Pharmaceuticals.

References: 1. American Cancer Society. Detailed Guide: Lung Cancer - Non-small Cell, What Are the Key Statistics for Lung Cancer?, revised 06/29/2006. (http://www.cancer.org/docroot/CRI/conte ... e_the_Key_ Statistics_About_Lung_Cancer_15.asp?sitearea, accessed 2/26/07)

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.subscribe.merck.de/ to register online, change your selection or discontinue this service.

Merck is a global pharmaceutical and chemical company with sales of EUR 6.3 billion in 2006, a history that began in 1668, and a future shaped by about 35,000 employees (including Merck Serono) in 56 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

http://www.merck.de/

Website: http://www.merck.de/

_________________

april/03 Diagnosed adenocarcinoma NSCLC

1/20/2006 Admitted to hospital Respiratory distress

1/23/2006 Ran to the light and is waiting for us to be rejoined in the Kingdom Of Heaven Her journey is Over but mine lingers on for Now!!!

"Life Isn't always beautiful, But it's a beautiful ride" Gary Allen

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klmline

Joined: 05 Mar 2006

Posts: 12

Posted: Thu Mar 01, 2007 12:25 am Post subject: Further Trials

http://www.targetedtherapies.org/rdt1_3.html

The Eastern Cooperative Oncology Group (ECOG) is planning a randomized phase II trial to assess the addition of the anti-vascular endothelial growth factor agent, bevacizumab (Avastin®), to L-BLP25 vaccine. It will compare the L-BLP25 vaccine plus bevacizumab to bevacizumab alone after best standard therapy for locally advanced lung cancer

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RandyW

MODERATOR

Joined: 27 Jan 2005

Posts: 3242

Location: Greensboro North Carolina

Posted: Thu Mar 01, 2007 5:11 am Post subject:

thankx for this info!!

_________________

april/03 Diagnosed adenocarcinoma NSCLC

1/20/2006 Admitted to hospital Respiratory distress

1/23/2006 Ran to the light and is waiting for us to be rejoined in the Kingdom Of Heaven Her journey is Over but mine lingers on for Now!!!

"Life Isn't always beautiful, But it's a beautiful ride" Gary Allen

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klmline

Joined: 05 Mar 2006

Posts: 12

Posted: Thu May 31, 2007 6:25 pm Post subject: Patient website is Live!

www.nsclcstudy.com

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Welthy

OVER 1000 POSTS !

Joined: 14 Mar 2006

Posts: 1181

Location: Chicago Suburbs

Posted: Thu May 31, 2007 6:38 pm Post subject:

Does anyone know the status of the Stimuvax/Avastin trial mentioned earlier in this post?

The most recent listed START trial is Stimuvax alone in Phase III for 3a and 3b patients.

Thanks for any help!

Welthy

_________________

‘There are none so blind as those who will not see.’ — Jonathan Swift

'Doh!' -- Homer Simpson

Beloved Husband - 67 (at diagnosis) – non-smoker/23 years, night sweats, coughing up blood & very SOB. Oxygen 24/7. Lung capacity 50%, blood/ox levels 88%. TB Test, Broncoscopy, CT, PET Scan

- 3-28-05 Wedge section biopsy Dx’d NSCLC Adenocarcinoma Stage IV. Primary tumor 3 x 5 cm, extensive mets both lungs. Mediastinum, hilar, lymph node & supraclavicular involvement. Histologic grade: Poorly differentiated Emphysema also.

-4-05 PLAN A -Chemo– TAXOL/CARBOPLATIN - 8 CYCLES(full strength dose)- 21 day cycle APRIL-AUGUST 2005

- PET & CAT in May & Aug. 2005 show marked reduction in all nodules.

- Cycle 8 – Second severe carboplatin reaction - no more platinum based drugs

- PLAN B - New chemo – TAXOTERE/GEMZAR-12 CYCLES (full strength dose)- 21 day cycle. SEPT 2005-MAY 2006 (22 actual chemo sessions in 12 cycles) Both drugs day 1 & Gemzar only day 7. Fatigue, high fevers, fingernail changes, & mouthsores. Procrit & Neulasta started during Cycle 3 (as needed).

-11-7-05 CAT & PET – more improvement. Large mass now 3.6 x 2.7 cm with less uptake. One small tumor in each lung.

-2-2-06 – PET & CAT scans show large mass down to 2.6 x 3.2 cm with lower SUV. R Lung clear. Areas of scarring in both lungs. Tumor in mid-left lung has grown.

-3-7-06 –15 RADIATION TREATMENTS to nuke the tumor in mid-left lung while continuing chemo. (Chemo 9b skipped)

-5-16-06 - Cycle 12a finished. Trouble breathing, skipped 12b. Allergic reaction to long term use of taxotere. Severe fluid retention everywhere. Oxygen 24/7 continues.

-5-22-06 - CAT & PET Scans. Radiated tumor gone, primary mass unchanged. More scarring, thickening, etc.

***CHEMO HOLIDAY for 3 mos

-6-6-06 - 1-3-07 - PLEURAL EFFUSION ISSUES - 14 Thoracentesis done ranging from 500-1300 cc's on both sides. No cancer cells ever found in any of the taps.

-8-28-06 - PET & CAT scans."Significant progression." Primary tumor larger and seven new tumors found in both lungs. Higher SUV uptake levels then initially.

-9-1-06 - PLAN C - TARCEVA 150 mg daily begins.

-11-16-06 PET/CAT scans. Tarceva didn't do squat. Disease progression. Some lung tumors same size, growth in old tumors, many new tumors in both lungs (about 17). All are over 1+ to 3+ cm. SUV higher on all (high being 12.1). New uptake in R-iliac and L-Scapula. Increased adenopathy in L-hilum with corresponding uptake. First time cancer has left his lungs. Crap.

-11-29-06 - Port installed.

-11-30-06 - 4-2-07- PLAN D - 19 WEEKLY NAVELBINE INFUSIONS (Full strength dose) Neupogen/Procrit (as needed) Zometa for bones every 4th treatment. Night sweats & some fatigue.

-2-2-07-PET/CAT scans. Overall improvement with decreased number & SUV activity in most of the lung tumors. All but one are smaller. Bone mets are better. Empty head too. Effusion issues cleared up! Praise God for prayers answered.

-3-28-07 - TWO YEAR ANNIVERSARY SINCE DX and now 70 years old!

-4-5-07 PET/CAT scans - Mixed results w/progression. On the good side, tumors in R-lung are still shrinking, bone mets are gone, two large areas in L-lung are stable. Progression in a tumor in the L-lung has increased in size & intensity and a larger area of new growth (3.9 x 2.4) with SUV 11.9 has occurred in subcarinal region. Need new chemo plan.

-4-18-07 - PLAN E - ALIMTA - 21 day cycle As of 5-30-07 3 cycles done. (Zometa still every 4 weeks)

Alimta has proved to be more challenging then we hoped. Crud. Fatigue, increased SOB & cough (some blood). Counts are good. Fevers/sweating episodes. Still on Oxygen 24/7.

Never been cancer free since diagnosis-- you CAN live with lung cancer!

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RandyW

MODERATOR

Joined: 27 Jan 2005

Posts: 3242

Location: Greensboro North Carolina

Posted: Thu May 31, 2007 8:20 pm Post subject:

The only thing I have seen quickly indicates that stimuvax alone trial provided great results and was starting to recruit for III stage. Will do alittle more looking

_________________

april/03 Diagnosed adenocarcinoma NSCLC

1/20/2006 Admitted to hospital Respiratory distress

1/23/2006 Ran to the light and is waiting for us to be rejoined in the Kingdom Of Heaven Her journey is Over but mine lingers on for Now!!!

"Life Isn't always beautiful, But it's a beautiful ride" Gary Allen

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