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Status:

UNKNOWN

Tinzaparin in Treating Patients With Metastatic Kidney Cancer That Cannot Be Removed By Surgery

Lead Sponsor:

University of Vermont

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Kidney Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief Summary

RATIONALE: Tinzaparin may stop the growth of kidney cancer by blocking blood flow to the tumor. PURPOSE: This phase I/II trial is studying the side effects of tinzaparin and to see how well it works ...

Detailed Description

OBJECTIVES: Primary * Determine the effect of tinzaparin sodium on fibrin formation (prothrombin fragment F1.2), thrombin generation (thrombin-antithrombin complexes), and fibrinolysis (D-Dimer) fro...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed renal cell carcinoma of clear cell histology
  • Tumors of mixed histology eligible if ≥ 50% of tumor has clear cell histology
  • No nonclear cell histologies, collecting duct tumors, oncocytomas, or transitional cell tumors
  • Metastatic and unresectable disease that is clinically extending beyond the regional lymph nodes (histological confirmation not required)
  • Patients who are inoperable for their primary tumor representing the sole site of disease are ineligible
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 2 cm by conventional techniques OR ≥ 1 cm by spiral CT scan
  • No known brain metastases
  • PATIENT CHARACTERISTICS:
  • Expected survival \> 2 months
  • CALGB (ECOG/ZUBROD) performance status (PS) 0-2 OR Karnofsky PS 60-100%
  • Hemoglobin ≥ 10 g/dL
  • Platelet count ≥ 100,000/mm\^3
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST/ALT ≤ 1.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • INR ≤ 1.5 times control value
  • PTT \< 1.5 times control value
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Patients must be able to receive subcutaneous injections at home
  • No other primary malignancy in the past 5 years other than basal cell carcinoma or carcinoma in situ of the cervix that has been curatively treated and is associated with a less than 30% risk of relapse in the next 5 years
  • No signs or symptoms of bleeding within 4 the past weeks
  • No known bleeding diathesis or high risk for bleeding due to any condition, including trauma within the past 4 weeks, active current bleeding, or hemorrhagic stroke or intraocular bleeding within the past 6 months
  • No active thromboembolism highly likely to require anticoagulation during the study period
  • No known or suspected history of type II heparin-induced thrombocytopenia
  • No allergy or hypersensitivity to heparin, tinzaparin sodium, pork products, sulfite, or benzyl alcohol
  • No uncontrolled severe intercurrent illness, including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • No uncontrolled arterial hypertension, history of gastrointestinal ulceration, and/or bleeding in the past 4 weeks
  • No diabetic retinopathy or history of retinal hemorrhage
  • Not pregnant or nursing
  • HIV-positive patients are allowed
  • PRIOR CONCURRENT THERAPY:
  • No treatment with anticoagulation lasting \> 1 month in the past 6 months
  • No anticoagulation, including treatment with a low molecular weight heparin, at any time within the past month
  • More than 4 weeks since prior surgery, radiation therapy, immunotherapy, or chemotherapy
  • Recovered from prior therapy
  • No other concurrent investigational agents
  • No other concurrent anticoagulation therapy, including oral anticoagulants, thrombolytic agents, or any form of heparin
  • Concurrent antiplatelet agents allowed
  • No spinal or epidural puncture, anesthesia, or post-operative indwelling epidural catheters within the past 48 hours
  • No other concurrent anticancer agents or therapies
  • No concurrent sex hormones except for postmenopausal hormone replacement
  • No concurrent chemotherapy or immunotherapy
  • No concurrent palliative radiotherapy
  • Concurrent urgent use of corticosteroids allowed

Exclusion

    Key Trial Info

    Start Date :

    December 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    35 Patients enrolled

    Trial Details

    Trial ID

    NCT00293501

    Start Date

    December 1 2005

    Last Update

    November 6 2013

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    University of Chicago Cancer Research Center

    Chicago, Illinois, United States, 60637-1470

    2

    Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, United States, 03756-0002

    3

    Vermont Cancer Center at University of Vermont

    Burlington, Vermont, United States, 05405-0110