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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Vermont
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dalteparin; Heparin, Low-Molecular-Weight; Tinzaparin

Criteria

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