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

NCT00293501 | Unknown Phase 1

• 3 other identifiers: CDR0000459794VCC-0403VCC-05-040
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

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 in treating patients with metastatic kidney cancer that cannot be removed by surgery.

Conditions

Kidney Cancer

Keywords

clear cell renal cell carcinoma; stage IV renal cell cancer; recurrent renal cell cancer

Outcome Measures

Primary Outcomes (1)

• Blood markers or coagulation as measured by plasma prothrombin F1.2, thrombin-antithrombin complexes, and D-dimers at 2 weeks, 2 months and 6 months

Secondary Outcomes (3)

• Blood markers of angiogenesis as measured by serum vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) at 2 weeks, 2 months, and 6 months

• Venous thromboembolism as measured by clinical evaluation at 6 months

• Progression free survival as measured by clinical evaluation at 4 months

Interventions

tinzaparin sodium DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Vermont: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Vermont Cancer Center at University of Vermont

Burlington, Vermont, 05405-0110, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Tinzaparin

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Deborah L. Ornstein, MD

  Yale University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 16, 2006
• First Posted: February 17, 2006
• Study Start: December 1, 2005
• Primary Completion: February 1, 2007
• Last Updated: November 6, 2013

Record last verified: 2007-02

Locations

US (3)