Clinical trial NCT00913913 (phase 2, status: terminated)
Conditions: metastatic renal cell carcinoma
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8
Drugs: bevacizumab
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    low accrual not allowing site to meeting statistical endpoints
  
Eligibility criteria:

        Inclusion Criteria:

          1. Histologically confirmed metastatic renal cell carcinoma with measurable disease.

          2. Adequate tumor tissue properly stored and available to produce lysate for a minimum of
             three vaccine preparations.

          3. Patients must be at least 4 weeks from their last therapy (tyrosine kinase inhibitors,
             immunotherapy, radiation, surgery or chemotherapy (6 weeks for nitrosureas) and
             recovered from all ill effects.

          4. Have measurable disease.

          5. Patients must be at least 4 weeks from major surgery, 1 week from minor surgery, and
             recovered from all ill effects.

          6. Karnofsky Performance Status ≥80%.

          7. Adequate end organ function:

          8. Women should not be lactating and, if of childbearing age, have a negative pregnancy
             test within two weeks of entry to the study.

          9. Appropriate contraception in both genders.

         10. The patient must be competent and have signed informed consent.

         11. Patients may have received one prior therapy with targeted therapies (e.g. sorafenib
             and sunitinib).

        Exclusion Criteria:

          1. Patients who have previously received bevacizumab or IL-2 are not eligible.

          2. Concomitant second malignancy except for non-melanoma skin cancer, and non-invasive
             cancer such as cervical CIS, superficial bladder cancer without local recurrence or
             breast CIS.

          3. In patients with a prior history of invasive malignancy, less than five years in
             complete remission.

          4. Positive serology for HIV, hepatitis B or hepatitis C which should be confirmed with
             antigenemia.

          5. Significant co-morbid illness such as uncontrolled diabetes or active infection that
             would preclude treatment on this regimen.

          6. Use of corticosteroids or other immunosuppression (if patient had been taking
             steroids, at least 2 weeks must have passed since the last dose). Inhaled steroids >
             1000mcg beclomethasone per day or its equivalent.

          7. History of inflammatory bowel disease or other serious autoimmune disease. (Not
             including thyroiditis and rheumatoid arthritis).

          8. Patients with organ allografts.

          9. Uncontrolled hypertension (BP >150/100 mmHg).

         10. Proteinuria dipstick > 3+ or > 2gm/24 hours, or a urine protein:creatinine ratio > 1.0
             at screening.

         11. Major surgery, open biopsy, significant traumatic injury within 28 days of starting
             treatment or anticipation of need for major surgical procedure during the course of
             the study.

         12. Minor surgical procedures, fine needle aspirations or core biopsies within 7 days
             prior to starting treatment. Central venous catheter placements are permitted.

         13. History of abdominal fistula, gastrointestinal perforation, or intrabdominal abscess
             within 6 months prior to starting treatment.

         14. Serious, non-healing wound, ulcer, or bone fracture.

         15. History of tumor-related or other serious hemorrhage, bleeding diathesis, or
             underlying coagulopathy.

         16. History of deep venous thrombosis, or other thrombotic event within the past six
             months or clinically significant peripheral vascular disease.

         17. Inability to comply with study and/or follow-up procedures.