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Clear Cell Sarcoma of the KidneyPhase 1NCT01061411

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

A Phase 1 study testing Dalteparin, Pharmacological Study and Sunitinib Malate in people with Clear Cell Sarcoma of the Kidney and Recurrent Renal Cell Carcinoma, run by Roswell Park Cancer Institute at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dalteparin, Pharmacological Study and Sunitinib Malate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
4 sitesin 2 countries
Study dates
6 Feb 2010to 21 Apr 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically confirmed renal cell carcinoma that is metastatic or unresectable
  • Renal carcinoma patients with predominant clear-cell histology are eligible; papillary renal cell carcinoma, oncocytoma, collecting duct tumors and transitional cell carcinoma are NOT eligible
  • No prior systemic treatments for metastatic disease are permitted, including antiangiogenic therapy, immunotherapy, chemotherapy and investigational therapy
  • Prior palliative radiation to metastatic lesion(s) is permitted, provided there is at least one measurable and/or evaluable lesion(s) that has not been irradiated
  • Radiation therapy must be completed > 4 weeks prior to registration
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as >= 20 mm with conventional techniques or as approximately >= 10 mm with spiral computed tomography (CT) scan (Response Evaluation Criteria in Solid Tumors [RECIST] 1.0 criteria)
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  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Leukocytes > 3,000/mm^3
  • Absolute neutrophil count > 1,500/mm^3
  • Platelets > 100,000/mm^3
  • Total bilirubin < 1.5 x laboratory upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/ alanine transaminase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x laboratory ULN
  • Creatinine < 1.5 x laboratory ULN
  • Prothrombin time (PT)/international normalized ratio (INR) < 1.5
  • Urine protein < 1+; if > 1+, 24 hour urine protein should be obtained and should be < 1000 mg
  • Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
  • Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign a written informed consent document
  • Except for Dalteparin that will be administered as a study drug, the patients should not take any other anticoagulants or antiplatelet agents during the study, including but not limited to nonsteroidal anti-inflammatory drugs (NSAID) (any dose of aspirin), warfarin or other anticoagulants

Who cannot join

  • Patients may not be receiving any other investigational agents
  • Patients with known central nervous system (CNS) metastases; patients should have a head CT/magnetic resonance imaging (MRI) within 4 weeks prior to treatment initiation; any imaging abnormality indicative of CNS metastases will exclude the patient from the study
  • Patients with a "currently active" second malignancy other than non-melanoma skin cancers are not eligible; patients are not considered to have a "currently active" malignancy if they have completed anti-cancer therapy and are considered by their physician to be at less than 30% risk of relapse
  • Patients with a large (> 2 cm) pulmonary lesion involving the trachea or one of the main bronchus and any endobronchial lesion
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to dalteparin
  • Evidence of bleeding diathesis within last 6 months
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  • Serious or non-healing wound, ulcer or bone fracture or active peptic ulceration
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Association class II, III, or IV), angina pectoris requiring nitrate therapy, recent myocardial infarction (< the last 6 months), cardiac arrhythmia, history of cerebrovascular accident (CVA) within 6 months (thrombotic or hemorrhagic), hypertension (defined as blood pressure of > 160 mmHg systolic and/or > 90 mm Hg diastolic on medication), hemorrhagic retinopathy, history of peripheral vascular disease, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients with an ejection fraction < 50% by multi gated acquisition scan (MUGA) scan are not eligible
  • Pregnant women are excluded from this study
  • History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to day 1 therapy
  • Invasive procedures defined as:
  • Major surgical procedure, open biopsy, or significant traumatic injury within 6 weeks prior to day 1 therapy
  • Anticipation of need for major surgical procedures during the course of the study
  • Core biopsy within 7 days prior to start therapy

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

United States2 sites

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

Other trials in United States

Netherlands2 sites

  • Academ Zienkenhuis Bij De University

    Amsterdam, 1007 MB

  • VU University Medical Center

    Amsterdam, 1081 HV

Other trials in Netherlands

About this study

Official title: Phase I Study of Dalteparin, A Low Molecular Weight Heparin (LMWH), in Combination With Sunitinib (SU11248), an Oral, Selective Multi-targeted Tyrosine Kinase Inhibitor, as First Line Treatment, in Patients With Metastatic Renal Cell Carcinoma

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the recommended dosing for the combination of sunitinib (sunitinib malate) and dalteparin in patients with metastatic renal cell carcinoma.

II. To evaluate safety and tolerability for the combination of sunitinib and dalteparin in patients with metastatic renal cell carcinoma.

III. To determine early signs of clinical activity of the combination of sunitinib and dalteparin in patients with metastatic renal cell carcinoma.

SECONDARY OBJECTIVES:

  1. To determine the clinical response rate of sunitinib and dalteparin in patients with metastatic renal cell carcinoma.

II. To determine time-to-progression (TTP) and overall survival amongst patients with metastatic renal cell carcinoma receiving sunitinib and dalteparin.

III. To determine the effect of sunitinib alone and dalteparin alone compared to the combination of dalteparin plus sunitinib on plasma coagulation parameters.

IV. To determine the effect of sunitinib alone and dalteparin alone compared to the combination of dalteparin plus sunitinib on angiogenesis parameters in blood.

OUTLINE: This is a dose-escalation study of dalteparin.

Patients receive sunitinib malate orally (PO) once daily (QD) in weeks 1-4 and dalteparin subcutaneously (SC) QD in week 6 during course 1. In all subsequent courses, patients receive sunitinib malate PO QD in weeks 1-4 and dalteparin SC QD in weeks 1-6. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4 weeks and then every 3 months for 3 years.

Being tested
Dalteparin, Pharmacological Study, Sunitinib Malate
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DalteparinDrug

    Given SC

  • Pharmacological StudyOther

    Correlative studies

  • Sunitinib MalateDrug

    Also called SU011248, SU11248, sunitinib, Sutent

    Given PO

Study groups in NCT01061411
Study groupRoleWhat they receive
Treatment (sunitinib malate, dalteparin)ExperimentalPatients receive sunitinib malate PO QD in weeks 1-4 and dalteparin SC QD in week 6 during course 1. In all subsequent courses, patients receive sunitinib malate PO QD in weeks 1-4 and dalteparin SC QD in weeks 1-6. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Dalteparin; Other: Pharmacological Study; Drug: Sunitinib Malate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Early signs of clinical activity of the combination of sunitinib malate and dalteparin

    Measured: Up to 4 years

  2. Incidence of toxicities for the combination of dalteparin and sunitinib malate

    Toxicities will be summarized by tabulation. Summaries will be made across all types of toxicities and by grade and type.

    Measured: Up to 4 weeks after last treatment

  3. Recommended dosing for the combination of dalteparin and sunitinib malate

    The maximally tolerated dose (MTD) will be the highest dose at which < 33% of patients (=< 2 out of 6 patients) suffer from dose limiting toxicities (DLTs) related to the combination treatment.

    Measured: Up to 4 weeks

Secondary outcomes (3)

  1. Clinical response rate of dalteparin and sunitinib malate, determined as the proportion of treated patients who had partial or complete response according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0

    Measured: Up to 4 weeks after last treatment

  2. Overall survival

    Described in all patients using Kaplan-Meier curves.

    Measured: Up to 4 years

  3. TTP

    Described in all patients using Kaplan-Meier curves.

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2010 (estimated)
  2. Study start6 Feb 2010
  3. Primary completion14 Oct 2015
  4. Study completion21 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01061411
Sponsor's protocol ID
I 145508
Other IDs
NCI-2009-01694, I 145508
Status last verified
Aug 2022
First submitted
1 Feb 2010
Last updated
5 Aug 2022
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dalteparin, Pharmacological Study and Sunitinib Malate in people with Clear Cell Sarcoma of the Kidney and Recurrent Renal Cell Carcinoma, run by Roswell Park Cancer Institute at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Early signs of clinical activity of the combination of sunitinib malate and dalteparin (time frame: Up to 4 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01061411.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.

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