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    Cartilage (Bovine and Shark) (PDQ®): Complementary and alternative medicine - Health Professional Information [NCI] - Human / Clinical Studies

    Cartilage Use in Cancer Treatment: Clinical Studies With Therapeutic Endpointsa,b

    Reference Citation(s) Type of Study Type(s) of Cancer Cartilage Product (Source) No. of Patients: Treated; Control Strongest Benefit Reportedc Concurrent Therapyd Level of Evidence Scoree
    No. = number; NSCLC = non-small cell lung cancer; wk = week.
    a See text and theNCI Dictionary of Cancer Termsfor additional information and definition of terms.
    b Other clinical studies have been conducted, but no results have been reported.
    c Strongest evidence reported that the treatment under study has anticancer activity or otherwise improves the well-being of cancer patients.
    d Chemotherapy, radiation therapy, hormonal therapy, or cytokine therapy given/allowed at the same time as cartilage therapy.
    e For information about Levels of Evidence analysis and an explanation of the level of evidence scores, seeLevels of Evidence for Human Studies of Cancer Complementary and Alternative Medicine.
    f Study results reported in review article or abstract form only; insufficient information presented for Level of Evidence analysis.
    g Insufficient information available to describe these studies separately.
    [8] Phase III randomized, placebo-controlled, double-blind trial (2 arms) Breast and colorectal BeneFin (shark) 42; 41 No statistically significant difference No 1i
    [21] Randomized controlled phase III trial NSCLC AE-941 (shark) 188; 191 None Cisplatin and vinorelbine; carboplatin and paclitaxel 1iA
    [1] Nonconsecutive case series Various advanced or recurrent Catrix (bovine) 31; None Complete response, 19 patients Yes 3iiiDiii
    [2] Phase II trial Various metastatic Catrix (bovine) 9; None Complete response, 1 patient, metastatic renal cell carcinoma No 3iiiDiii
    [3] Phase II trial Metastatic renal cell Catrix (bovine) 35; None Partial response, 3 of 22 evaluable patients Unknown Nonef
    [10,16] Two phase I/II trialsg Various advanced, refractory solid tumors AE-941/ Neovastat (shark) 331; None Improved survival, higher versus lower doses, patients with stage III/IV non-small cell lung cancer (unplanned retrospective analysis), and patients with refractory renal cell carcinoma (prospective analysis) Unknown Nonef
    [9] Phase I/II trial Advanced non-small cell lung cancer AT-941/Neovastat (shark) 80; None No dose-limiting toxicity found. Improved survival time in patients receiving the highest doses when survival analysis was conducted, and stable disease for greater number of patients receiving higher doses. No tumor response observed. Yes or refused standard therapy None
    [4] Phase I/II trial Various advanced solid tumors Cartilade (shark) 60; None Stable disease for 12 wk or more, 10 of 50 evaluable patients No 3iiiDiii
    [5] Phase II trial Metastatic, refractory breast Unknown (shark) 20; None Stable disease for 8 wk or more, 2 of 10 evaluable patients No Nonef
    [5] Phase II trial Metastatic, hormone- refractory prostate Unknown (shark) 12; None Stable disease for 20 wk or more, 3 of 10 evaluable patients No Nonef
    [6] Phase II trial Various advanced brain BeneFin (shark) 12; None Stable disease for 20 wk or more, 2 of 10 evaluable patients No Nonef

    References:

    1. Prudden JF: The treatment of human cancer with agents prepared from bovine cartilage. J Biol Response Mod 4 (6): 551-84, 1985.
    2. Romano CF, Lipton A, Harvey HA, et al.: A phase II study of Catrix-S in solid tumors. J Biol Response Mod 4 (6): 585-9, 1985.
    3. Puccio C, Mittelman A, Chun P, et al.: Treatment of metastatic renal cell carcinoma with Catrix. [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-769, 246, 1994.
    4. Miller DR, Anderson GT, Stark JJ, et al.: Phase I/II trial of the safety and efficacy of shark cartilage in the treatment of advanced cancer. J Clin Oncol 16 (11): 3649-55, 1998.
    5. Leitner SP, Rothkopf MM, Haverstick L, et al.: Two phase II studies of oral dry shark cartilage powder (SCP) with either metastatic breast or prostate cancer refractory to standard treatment. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A-240, 1998.
    6. Rosenbluth RJ, Jennis AA, Cantwell S, et al.: Oral shark cartilage in the treatment of patients with advanced primary brain tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A-554, 1999.
    7. Batist G, Champagne P, Hariton C, et al.: Dose-survival relationship in a phase II study of Neovastat in refractory renal cell carcinoma patients. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1907, 2002.
    8. Loprinzi CL, Levitt R, Barton DL, et al.: Evaluation of shark cartilage in patients with advanced cancer: a North Central Cancer Treatment Group trial. Cancer 104 (1): 176-82, 2005.
    9. Latreille J, Batist G, Laberge F, et al.: Phase I/II trial of the safety and efficacy of AE-941 (Neovastat) in the treatment of non-small-cell lung cancer. Clin Lung Cancer 4 (4): 231-6, 2003.
    10. Falardeau P, Champagne P, Poyet P, et al.: Neovastat, a naturally occurring multifunctional antiangiogenic drug, in phase III clinical trials. Semin Oncol 28 (6): 620-5, 2001.
    11. AE 941--Neovastat. Drugs R D 1 (2): 135-6, 1999.
    12. Cassileth BR: Shark and bovine cartilage therapies. In: Cassileth BR, ed.: The Alternative Medicine Handbook: The Complete Reference Guide to Alternative and Complementary Therapies. New York, NY: WW Norton & Company, 1998, pp 197-200.
    13. Holt S: Shark cartilage and nutriceutical update. Altern Complement Ther 1 (6): 414-16, 1995.
    14. Hunt TJ, Connelly JF: Shark cartilage for cancer treatment. Am J Health Syst Pharm 52 (16): 1756, 1760, 1995.
    15. AE 941. Drugs R D 5 (2): 83-9, 2004.
    16. Batist G, Patenaude F, Champagne P, et al.: Neovastat (AE-941) in refractory renal cell carcinoma patients: report of a phase II trial with two dose levels. Ann Oncol 13 (8): 1259-63, 2002.
    17. Berbari P, Thibodeau A, Germain L, et al.: Antiangiogenic effects of the oral administration of liquid cartilage extract in humans. J Surg Res 87 (1): 108-13, 1999.
    18. Ryoo JJ, Cole CE, Anderson KC: Novel therapies for multiple myeloma. Blood Rev 16 (3): 167-74, 2002.
    19. Bukowski RM: AE-941, a multifunctional antiangiogenic compound: trials in renal cell carcinoma. Expert Opin Investig Drugs 12 (8): 1403-11, 2003.
    20. New treatment option for postmenopausal women with early breast cancer. Expert Rev Anticancer Ther 2 (6): 617, 2002.
    21. Lu C, Lee JJ, Komaki R, et al.: Chemoradiotherapy with or without AE-941 in stage III non-small cell lung cancer: a randomized phase III trial. J Natl Cancer Inst 102 (12): 859-65, 2010.

    This information is produced and provided by the National Cancer Institute (NCI). The information in this topic may have changed since it was written. For the most current information, contact the National Cancer Institute via the Internet web site at http:// cancer .gov or call 1-800-4-CANCER.

    WebMD Public Information from the National Cancer Institute

    Last Updated: 8/, 015
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