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Dalteparin and Sunitinib Malate as First-Line Therapy in Treating Patients With Kidney Cancer That is Metastatic or Cannot Be Removed by Surgery

NCT01061411 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-08-05

No results posted yet for this study

Summary

This phase I trial studies the side effects and best dose of dalteparin when given together with sunitinib malate in treating patients with kidney cancer that has spread to other parts of the body or cannot be removed by surgery. Anticoagulants, such as dalteparin, help prevent blood clots and have been shown to increase survival in patients with cancer. Anticoagulants may also prevent the formation of new blood vessels. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by inhibiting new blood vessels and blocking blood flow to the tumor. Giving dalteparin together with sunitinib malate may starve tumors and kill more tumor cells.

Conditions

  • Clear Cell Sarcoma of the Kidney
  • Recurrent Renal Cell Carcinoma
  • Stage III Renal Cell Cancer
  • Stage IV Renal Cell Cancer

Interventions

DRUG

Dalteparin

Given SC

OTHER

Pharmacological Study

Correlative studies

DRUG

Sunitinib Malate

Given PO

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Roswell Park Cancer Institute

    lead OTHER

Principal Investigators

  • Saby George · Roswell Park Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-06
Primary Completion
2015-10-14
Completion
2017-04-21

Countries

  • United States
  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01061411 on ClinicalTrials.gov