RATIONALE: Shark cartilage extract may stop the growth of kidney cancer by stopping blood flow to the tumor. PURPOSE: Randomized phase III trial to determine the effectiveness of shark cartilage extract in treating patients who have metastatic kidney cancer that has not responded to biological therapy.

Condition	Treatment or Intervention	Phase
Stage IV Renal Cell Cancer Renal Cell Adenocarcinoma recurrent renal cell cancer	Procedure: biological response modifier therapy  Procedure: growth factor antagonist therapy  Procedure: anti-cytokine therapy  Procedure: cancer prevention intervention  Procedure: antiangiogenesis therapy  Procedure: complementary and alternative therapy  Drug: shark cartilage	Phase III

Further Study Details: 

OBJECTIVES: I. Compare survival of patients with metastatic renal cell carcinoma refractory to immunotherapy after receiving treatment with AE-941 (Neovastat; shark cartilage extract) versus placebo. II. Compare the time to progression and one-year survival rate in these patients after receiving these treatments. III. Determine the safety of AE-941 (Neovastat; shark cartilage extract) in these patients. IV. Compare the overall tumor response rate, duration of response, and quality of life in these patients after receiving these treatments.

PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to number of organs with metastases (1 vs more than 1) and ECOG performance status (0 vs 1). Patients are randomized to one of two treatment arms. Arm I: Patients receive oral AE-941 (Neovastat; shark cartilage extract) twice a day. Arm II: Patients receive oral placebo twice a day. Treatment continues in the absence of unacceptable toxicity or disease progression. Quality of life is assessed on day 1 and then every 8 weeks thereafter. Patients are followed every 4 weeks until disease progression and then every 8 weeks thereafter.

PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study within 12 months.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed renal cell adenocarcinoma; Disease progression within 16 weeks after first-line therapy, which included interleukin-2 and/or interferon; Metastatic disease not amenable to surgery
• Measurable and/or evaluable disease
• No more than one line of prior anticancer treatment for renal cell carcinoma
• No pure papillary cell tumor, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumor
• No brain metastases

--Prior/Concurrent Therapy--

• Biologic therapy: See Disease Characteristics; At least 1 month but no longer than 8 months since prior immunotherapy
• Chemotherapy: Not specified
• Endocrine therapy: At least 1 week since prior systemic corticosteroids for symptomatic treatment of renal cell carcinoma; At least 28 days since prior medroxyprogesterone acetate; No concurrent medroxyprogesterone acetate; Concurrent corticosteroids for symptomatic treatment of neurological complications caused by renal cancer allowed
• Radiotherapy: Concurrent radiotherapy to symptomatic lesions for symptom relief allowed
• Surgery: See Disease Characteristics; Concurrent surgical removal of symptomatic lesions for symptom relief allowed
• Other: At least 28 days since other prior experimental therapeutic agents; At least 28 days since other prior shark cartilage products; No other concurrent therapies for metastatic renal cell carcinoma; No other concurrent shark cartilage products

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-1
• Life expectancy: More than 3 months
• Hematopoietic: Platelet count at least 100,000/mm3; WBC at least 2,500/mm3; Hemoglobin at least 8 g/dL (epoetin alfa allowed)
• Hepatic: Not specified
• Renal: Calcium no greater than the upper limit of normal (ULN) (bisphosphonates allowed); Creatinine no greater than 2 times ULN
• Other: No other prior malignancy within past 5 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix; No severe allergy to fish or seafood; No medical condition that would interfere with intake and/or absorption of study medication (e.g., gastrectomy or major intestinal resection); No significant medical or psychiatric condition that would preclude study; Not pregnant; Negative pregnancy test; Fertile patients must use adequate contraception

Canada, Quebec
      Aeterna Laboratories, Incorporated, Quebec City,  Quebec,  G1P 4P5,  Canada

Study chairs or principal investigators

Pierre Champagne,  Study Chair,  Aeterna Laboratories   

Study ID Numbers:  CDR0000067999; AETERNA-AE-RC-99-02; CAN-CCI-ETH-00-32-17; CCF-IRB-3664; JGH-00023; UCMC-0006305; UPCC-2800
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  July 5, 2000
ClinicalTrials.gov Identifier:  NCT00005995
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08