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/
>
>
>
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