you have to check out the abstracts that are listed. go to pubmed and
read them, let us know what you think.

--- In experimentalandunconventional@yahoogroups.com, Lars Tong
Stromberg <kokostrollet@...> wrote:
>
> sounds promising in what way. Doesn´t say nada about
> any results..
>
> --- waveresearchlab <waveresearchlab@...> skrev:
>
> > Study of Clostridium Novyi-NT Spores in Solid Tumors
> > Malignancies
> >
> http://www.clinicaltrials.gov/ct/show/NCT00358397?order=3
> >
> > This study is currently recruiting patients.
> > Verified by Sidney Kimmel Comprehensive Cancer
> > Center July 2006
> > Sponsored by: Sidney Kimmel Comprehensive Cancer
> > Center
> > Information provided by: Sidney Kimmel
> > Comprehensive Cancer Center
> > ClinicalTrials.gov Identifier: NCT00358397
> >
> > Purpose
> > One time IV infusion of Clostridium novyi-NT spores
> > to treat solid
> > tumors which have not responded to standard therapy.
> > Condition Intervention Phase
> > Solid Tumors
> > Drug: Costridium novyi-NT spores
> > Phase I
> >
> > MedlinePlus consumer health information
> >
> > Study Type: Interventional
> > Study Design: Treatment, Non-Randomized, Open Label,
> > Uncontrolled,
> > Single Group Assignment, Safety/Efficacy Study
> >
> > Official Title: Phase I Safety Study of Clostridium
> > Novyi-NT Spores in
> > Patients With Treatment-Refractory Solid Tumor
> > Malignancies
> > Further study details as provided by Sidney Kimmel
> > Comprehensive
> > Cancer Center:
> > Primary Outcomes: To determine the safety profile,
> > dose limiting
> > toxicities (DLT), and maximum tolerated dose (MTD)
> > of C. novyi–NT in
> > humans with treatment-refractory solid tumor
> > malignancies when given
> > as a single intravenous injection.
> > Secondary Outcomes: To document preliminary evidence
> > of anti-tumor
> > activity of C. novyi-NT in humans with
> > treatment-refractory solid
> > tumor malignancies when given as a single
> > intravenous injection.; To
> > analyze the pharmacokinetics of C. novyi-NT after
> > administration to
> > humans with treatment-refractory solid tumor
> > malignancies when given
> > as a single intravenous injection.; To measure the
> > host immune and
> > inflammatory response to C. novyi-NT in humans with
> > treatment-refractory solid tumor malignancies when
> > given as a single
> > intravenous injection.
> > Expected Total Enrollment: 20
> >
> > Study start: July 2006; Expected completion: July
> > 2008
> > Last follow-up: July 2006; Data entry closure: July
> > 2006
> > This is a phase I dose escalation study using a
> > single dose of
> > Clostridium novyi-NT spores in patients with
> > treatment-refractory
> > solid tumor malignancies. The overall objective of
> > this study is to
> > determine the safety and document any preliminary
> > evidence of
> > anti-tumor activity in this patient population.
> >
> > Eligibility
> > Ages Eligible for Study: 18 Years and above,
> > Genders Eligible for
> > Study: Both
> > Criteria
> >
> > Inclusion Criteria:
> >
> > 1. Documented solid tumor malignancy as proven by
> > referral CT scan
> > of the chest, abdomen and pelvis.
> > 2. Referral CT scan that demonstrates a necrotic
> > core in primary
> > target measuring at least 1 cm in diameter.
> > 3. Patients must be refractory to standard
> > chemotherapy or for whom
> > no standard treatment exists. At least four weeks
> > must have elapsed
> > since completion of any prior chemotherapy.
> > 4. Patients must have measurable disease; defined
> > as at least one
> > lesion whose longest diameter can be accurately
> > measured as >2 cm.
> > 5. ECOG performance status of 0 or 1.
> > 6. Prior locoregional therapy, including
> > cryotherapy,
> > radiofrequency ablation, or regional chemotherapy is
> > allowed if at
> > least 6 weeks have elapsed.
> > 7. Prior radiation therapy is allowed. At least 6
> > weeks must have
> > elapsed since the completion of radiation therapy
> > and the patient must
> > have recovered from side effects.
> > 8. Prior systemic radionuclide therapy is
> > allowed. At least 4 weeks
> > must have elapsed since completion of the therapy.
> > 9. Prior surgery is allowed. At least 6 weeks
> > must have elapsed
> > since the completion of major surgery and the
> > patient must be fully
> > recovered from this surgery and any attendant
> > post-surgical complications.
> > 10. Patients must be 18 years of age or older
> > 11. Patients of childbearing potential must use
> > adequate birth
> > control measures
> > 12. Negative serum pregnancy test for females of
> > childbearing potential.
> >
> > Exclusion Criteria:
> >
> > 1. Weight < 135 kg
> > 2. Chronic renal failure requiring hemodialysis
> > or peritoneal dialysis
> > 3. Tumor lesion that is not accessible to
> > percutaneous drainage.
> > 4. Any single contiguous lesion greater than >
> > 12.5 cm.
> > 5. The sum of the largest cross-sectional
> > diameters from any number
> > of non-contiguous lesions > 2 cm cannot be > 25 cm.
> > 6. Use of any investigational drug within 30 days
> > prior to
> > screening or within 5 half-lives of the agent,
> > whichever is longer.
> > 7. Any documented evidence of primary brain
> > malignancy or brain
> > metastases
> > 8. Patients with any clinically significant
> > ascites or
> > portosystemic hypertension, chronic jaundice or
> > cirrhosis.
> > 9. Patients with indwelling intrahepatic arterial
> > pumps
> > 10. Patients with prosthetic joints, prosthetic
> > valves, pacemakers
> > or any other implanted foreign materials.
> > 11. Patients with any clinically significant
> > pleural effusions
> > 12. Patients with any evidence of hemodynamic
> > compromise from a
> > pericardial effusion.
> > 13. Documented cirrhosis of the liver by clinical
> > scenarios
> > encompassing radiographic, clinical and laboratory
> > results
> > 14. Ongoing treatment with any immunosuppressive
> > agent(s)
> > 15. Any evidence of serious infections or history
> > of chronic or
> > recurrent infectious disease in the previous 3
> > months.
> > 16. Patients with opportunistic infections
> > 17. Documented HIV infection.
> > 18. Active or chronic Hepatitis B or Hepatitis C.
> > 19. Presence of a transplanted solid organ.
> > 20. History of an autoimmune disorder
> > 21. History of Diabetes Mellitus (type I or II)
> > 22. History of rheumatic fever, endocarditis, or
> > greater than mild
> > valvular disease.
> > 23. Patients who depend upon COX II inhibitors or
> > NSAIDS
> > 24. History of ongoing and active arterial
> > vasculopathy or evidence
> > of end organ damage.
> > 25. History of an ischemic insult in the previous
> > 12 months
> > 26. History of venous or lymphatic stasis
> > resulting in venous stasis
> > ulcers or greater than 2+ edema or lymphedema.
> > 27. History of a splenectomy
> > 28. Patients with a documented Penicillin or
> > Metronidazole allergy
> > 29. Patients with a documented allergy to
> > radiology contrast dye.
> > 30. Patient with active diverticulitis
> > 31. Patient with active dental abscesses
> > 32. Patients with inflammatory bowel disease
> > 33. Patients with angiosarcoma
> > 34. Patients with history of a positive PPD, past
> > TB infection or
> > past atypical mycobacterium infection.
> >
> > Location and Contact Information
> > Please refer to this study by ClinicalTrials.gov
> > identifier NCT00358397
> >
> > Luis A Diaz, MD 443-287-6539 ldiaz1@...
> >
> > Maryland
> > Johns Hopkins Medical Institutes, Baltimore,
> > Maryland, 21231,
> > United States; Recruiting
> > Luis A Diaz, MD, Principal Investigator
> > Katherine Thornton, MD, Sub-Investigator
> > Bert Vogelstein, M.D., Sub-Investigator
> > Ross Donehower, M.D., Sub-Investigator
> > Michael Choti, M.D., Sub-Investigator
> > Kenneth Kinzler, Ph.D., Sub-Investigator
> >
> > Study chairs or principal investigators
> >
> > Luis A Diaz, MD, Principal Investigator, Johns
> > Hopkins Medicine
> >
> > More Information
> >
> > Publications
> >
> > Diaz LA Jr, Cheong I, Foss CA, Zhang X, Peters BA,
> > Agrawal N,
> > Bettegowda C, Karim B, Liu G, Khan K, Huang X, Kohli
> > M, Dang LH, Hwang
> > P, Vogelstein A, Garrett-Mayer E, Kobrin B, Pomper
> > M, Zhou S, Kinzler
> > KW, Vogelstein B, Huso DL. Pharmacologic and
> > toxicologic evaluation of
> > C. novyi-NT spores. Toxicol Sci. 2005
> > Dec;88(2):562-75. Epub 2005 Sep 14.
> >
> > Folkman J. A novel anti-vascular therapy for cancer.
> > Cancer Biol Ther.
> > 2004 Mar;3(3):338-9. Epub 2004 Mar 29. No abstract
> > available.
> >
> > Dang LH, Bettegowda C, Agrawal N, Cheong I, Huso D,
> > Frost P, Loganzo
> > F, Greenberger L, Barkoczy J, Pettit GR, Smith AB
> > 3rd, Gurulingappa H,
> > Khan S, Parmigiani G, Kinzler KW, Zhou S, Vogelstein
> > B. Targeting
> > vascular and avascular compartments of tumors with
> > C. novyi-NT and
> > anti-microtubule agents. Cancer Biol Ther. 2004
> > Mar;3(3):326-37. Epub
> > 2004 Mar 12.
> >
> http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?CMD=search&DB=pubmed
> >
> > Bettegowda C, Dang LH, Abrams R, Huso DL, Dillehay
> > L, Cheong I,
> > Agrawal N, Borzillary S, McCaffery JM, Watson EL,
> > Lin KS, Bunz F,
> > Baidoo K, Pomper MG, Kinzler KW, Vogelstein B, Zhou
> > S. Overcoming the
> > hypoxic barrier to radiation therapy with anaerobic
> > bacteria. Proc
> > Natl Acad Sci U S A. 2003 Dec 9;100(25):15083-8.
> > Epub 2003 Dec 1.
> >
> > Dang LH, Bettegowda C, Huso DL, Kinzler KW,
> > Vogelstein B. Combination
> > bacteriolytic therapy for the treatment of
> > experimental tumors. Proc
> > Natl Acad Sci U S A. 2001 Dec 18;98(26):15155-60.
> > Epub 2001 Nov 27.
> >
> > Agrawal N, Bettegowda C, Cheong I, Geschwind JF,
> > Drake CG, Hipkiss EL,
> > Tatsumi M, Dang LH, Diaz LA Jr, Pomper M, Abusedera
> > M, Wahl RL,
> > Kinzler KW, Zhou S, Huso DL, Vogelstein B.
> > Bacteriolytic therapy can
> > generate a potent immune response against
> > experimental tumors. Proc
> > Natl Acad Sci U S A. 2004 Oct 19;101(42):15172-7.
> > Epub 2004 Oct 7.
> >
> > Jain RK, Forbes NS. Can engineered bacteria help
> > control cancer? Proc
> > Natl Acad Sci U S A. 2001 Dec 18;98(26):14748-50. No
> > abstract available.
> >
> >
> >
> >
> >
> >
> > Yahoo! Groups Links
> >
> >
> http://groups.yahoo.com/group/experimentalandunconventional/
> >
> >
> >
> experimentalandunconventional-unsubscribe@yahoogroups.com
> >
> >
> >
> >
> >
>