Cartilage (Bovine and Shark) Human/Clinical Studies At least a dozen clinical studies of cartilage as a treatment for cancer have been conducted since the early 1970s.[1-10] Reviewed in [11-16] (See table at the end of this section.) However, results from only 3 studies have been published in peer-reviewed, scientific journals.[1,2,4] It is not clear whether any of the patients in the conducted studies were children. Additional clinical studies are under way; however, the cumulative evidence to date is inconclusive regarding the effectiveness of cartilage as a cancer treatment. Two of the 3 published clinical studies evaluated the use of Catrix, the previously mentioned (Laboratory/Animal/Preclinical Studies) powdered preparation of bovine (cow) cartilage, as a treatment for various solid tumors.[1,2] One of these studies was a case series that included 31 patients;[1] the other was a phase II clinical trial that included 9 patients.[2] In the case series,[1] all patients were treated with subcutaneously injected and/or oral Catrix; however, 3 patients (1 with squamous cell carcinoma of the skin and 2 with basal cell carcinoma of the skin) were treated with topical preparations as well. The individual dose, the total dose, and the duration of Catrix treatment in this series varied from patient to patient; however, the minimum treatment duration was 7 months, and the maximum duration was more than 10 years. Eighteen patients had been treated with conventional therapy (surgery, chemotherapy, radiation therapy, hormonal therapy) within 1 year of the start of Catrix treatment; 9 patients received conventional therapy concurrently (at the same time) with Catrix treatment; and 7 patients received conventional therapy both prior to and during Catrix treatment. It was reported that 19 patients had a complete response, 10 patients had a partial response, and 1 patient had stable disease following Catrix treatment. The remaining patient did not respond to cartilage therapy. Eight of the patients with a complete response received no prior or concurrent conventional therapy. Approximately half of the patients with a complete response eventually experienced recurrent cancer. This clinical study had several weaknesses that could have affected its outcome, including the absence of a control group and the receipt of prior and/or concurrent conventional therapy by most patients. In the phase II trial,[2] Catrix was administered by subcutaneous injection only. All patients in this trial had progressive disease following radiation therapy and/or chemotherapy. Identical individual doses of Catrix were given to each patient, but the duration of treatment and the total delivered dose varied because of disease progression or death. The minimum duration of Catrix treatment in this study was 4 weeks. It was reported that 1 patient (with metastatic renal cell carcinoma) had a complete response that lasted more than 39 weeks. The remaining 8 patients did not respond to Catrix treatment. The researchers in this trial also investigated whether Catrix had an effect on immune system function in these patients. No consistent trend or change in the numbers, percentages, or ratios of white blood cells (i.e., total lymphocyte counts, total T cell counts, total B cell counts, percentage of T cells, percentage of B cells, ratio of helper T cells to cytotoxic T cells) was observed, although increased numbers of T cells were found in 3 patients. Partial results of a third clinical study of Catrix are described in an abstract submitted for presentation at a scientific conference,[3] but complete results of this study have not been published in a peer-reviewed, scientific journal. In the study, 35 patients with metastatic renal cell carcinoma were divided into 4 groups, and the individuals in each group were treated with identical doses of subcutaneously injected and/or oral Catrix. Three partial responses and no complete responses were observed among 22 evaluable patients who were treated with Catrix for more than 3 months. Two of the 22 evaluable patients were reported to have stable disease and 17 were reported to have progressive disease following Catrix therapy. No relationship could be established between Catrix dose and tumor response in this study. The third published study of cartilage as a treatment for cancer was a phase I/II trial that tested the safety and the efficacy of orally administered Cartilade, a commercially available powdered preparation of shark cartilage, in 60 patients with various types of advanced solid tumors.[4] All but 1 patient in this trial had been treated previously with conventional therapy. According to the design of the study, no additional anticancer treatment could be given concurrently with Cartilade therapy. No complete responses or partial responses were observed among 50 evaluable patients who were treated with Cartilade for at least 6 weeks. However, stable disease that lasted 12 weeks or more was reported for 10 of the 50 patients. All 10 of these patients eventually experienced progressive disease. Partial results of 3 other clinical studies of powdered shark cartilage are described in 2 abstracts submitted for presentation at scientific conferences,[5,6] but complete results of these studies have not been published in peer-reviewed, scientific journals. All 3 studies were phase II clinical trials that involved patients with advanced disease; 2 of the studies were conducted by the same group of investigators.[5] These 3 studies enrolled 20 patients with breast cancer,[5] 12 patients with prostate cancer,[5] and 12 patients with primary brain tumors.[6] All patients had been treated previously with conventional therapy. No other anticancer treatment was allowed concurrently with cartilage therapy. In 2 of the studies,[5] the name of the cartilage product was not identified; however, in the third study,[6] the commercially available product BeneFin was used. Ten patients in each study completed at least 8 weeks of treatment and were, therefore, considered evaluable for response. No complete responses or partial responses were observed in any of the studies. Two evaluable patients in the breast cancer study were reported to have stable disease that lasted 8 weeks or more; 2 evaluable patients in the brain tumor study had stable disease that lasted 20 weeks or more; and 3 evaluable patients in the prostate cancer study had stable disease that also lasted 20 weeks or more. A randomized phase III clinical trial of BeneFin in patients with advanced colorectal or breast cancer ended patient recruitment in 2003.[9] No results from this trial have been reported to date. Patients in the trial were randomly assigned to receive either cartilage or a placebo orally 3 to 4 times a day. Survival was the principal endpoint measured in this trial, but quality of life was also assessed. The safety and the efficacy of AE-941/Neovastat, the previously mentioned aqueous extract of shark cartilage, have also been examined in clinical studies.[7,10,17-19] Reviewed in [12,11] It has been reported that AE-941/Neovastat has little toxicity. Reviewed in [11,12] In addition, there is evidence from a randomized clinical trial that examined the effect of AE-941/Neovastat on angiogenesis associated with surgical wound repair that this product contains at least 1 antiangiogenic component that is orally bioavailable.[19] AE-941/Neovastat was administered to 331 patients with advanced solid tumors (including lung, prostate, breast, and kidney tumors) in 2 phase I/II trials. Reviewed in [11] The results of these trials, however, have not been fully reported. A retrospective analysis involving a subgroup of patients with advanced non-small cell lung cancer suggests that AE-941/Neovastat is able to lengthen the survival of patients with this disease. Reviewed in [11] Furthermore, in a prospective analysis involving 22 patients with refractory renal cell carcinoma, survival was longer in patients treated with 240 mL/day AE-941/Neovastat than in patients treated with only 60 mL/day.[7,17] Reviewed in [11] In 2001, a phase II trial of AE-941/Neovastat was initiated in patients with relapsed or refractory multiple myeloma. This trial closed approximately 1 year later, however, and no results have been reported.[10] Two randomized phase III trials of AE-941/Neovastat in patients with advanced cancer have been approved by the United States Food and Drug Administration (FDA). In 1 trial, which is ongoing, treatment with oral AE-941/Neovastat plus chemotherapy and radiation therapy is being compared to treatment with placebo plus the same chemotherapy and radiation therapy in patients with stage III non-small cell lung cancer.[8] In the second trial, which closed to patient recruitment in 2002, treatment with oral AE-941/Neovastat was compared to treatment with placebo in patients with metastatic renal cell carcinoma.[18] Results from this second phase III trial have not been reported in the peer-reviewed, scientific literature. References Prudden JF: The treatment of human cancer with agents prepared from bovine cartilage. J Biol Response Mod 4 (6): 551-84, 1985. [PUBMED Abstract] 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. [PUBMED Abstract] 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. 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. [PUBMED Abstract] 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. 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. 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. Lu C, University of Texas - MD Anderson Cancer Center: Phase III Randomized Study of Induction Platinum-Based Chemotherapy and Radiotherapy With or Without Æ-941 (Neovastat) in Patients With Unresectable Stage IIIA or IIIB Non-Small Cell Lung Cancer, MDA-ID-99303, Clinical trial, Active. [PDQ Clinical Trial] Loprinzi CL, North Central Cancer Treatment Group: Phase III Randomized Study of Shark Cartilage (BeneFin™) in Patients With Advanced Colorectal or Breast Cancer, NCCTG-971151, Clinical trial, Closed. [PDQ Clinical Trial] Champagne P, Aeterna Laboratories, Incorporated: Phase II Study of AE-941 (Neovastat) in Patients With Early Relapse or Refractory Multiple Myeloma, AETERNA-AE-MM-00-02, Clinical trial, Closed. [PDQ Clinical Trial] 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. [PUBMED Abstract] AE 941--Neovastat. Drugs R D 1 (2): 135-6, 1999. [PUBMED Abstract] 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. Reviews of Therapies: Biologic/Organic/Pharmacologic Therapies: Cartilage. Houston, Tex: M.D. Anderson Cancer Center, 2003. Available online. Last accessed June 11, 2004. Holt S: Shark cartilage and nutriceutical update. Altern Complement Ther 1: 414-16, 1995. Hunt TJ, Connelly JF: Shark cartilage for cancer treatment. Am J Health Syst Pharm 52 (16): 1756, 1760, 1995. [PUBMED Abstract] 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. [PUBMED Abstract] Champagne P, Aeterna Laboratories, Incorporated: Phase III Randomized Study of AE-941 (Neovastat) in Patients With Metastatic Renal Cell Carcinoma Refractory to Immunotherapy, AETERNA-AE-RC-99-02, Clinical trial, Closed. [PDQ Clinical Trial] 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. [PUBMED Abstract] Read More On This Subject

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