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Kidney CancerPhase 1NCT00589550

PEG-Interferon Alfa-2b and Sorafenib in Treating Patients With Unresectable or Metastatic Kidney Cancer

A Phase 1 study testing PEG-interferon alfa-2b, Sorafenib and gene expression analysis in people with Kidney Cancer, run by Thomas Olencki at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stop the growth of kidney cancer by blocking blood flow to the tumor. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Cancer
What is being tested?
PEG-interferon alfa-2b, Sorafenib and gene expression analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
Feb 2008to Jan 2009
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Must have histologically or cytologically confirmed clear cell renal cell carcinoma (RCC)
  • Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension and is ≥ 1.0 cm by spiral CT scan
  • No prior treatment except
  • PATIENT CHARACTERISTICS:
  • ECOG performance status 0-1
  • Life expectancy > 6 months
Show all 47Show fewer
  • Good/intermediate Motzer prognostic status
  • ANC ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 10.0 g/dL
  • Total bilirubin ≤ 2.0 mg/dL
  • AST and ALT < 2.5 times normal
  • Creatinine ≤ 1.8 mg/dL OR creatinine clearance > 50 mL/min
  • Calcium < 12 mg/dL (when corrected for serum albumin)
  • INR < 1.5 times upper limit of normal
  • Adequate cardiac function, defined as left ventricular ejection fraction ≥ 40% by 2D echo
  • Pulse oximetry ≥ 90% at rest on room air
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No evidence of bleeding diathesis
  • No uncontrolled coagulation disorders
  • No active infections requiring IV antibiotics
  • No known HIV, hepatitis C, or hepatitis B
  • No autoimmune disease requiring ongoing therapy
  • No requirement for adrenal replacement
  • No angina (controlled or uncontrolled)
  • No uncontrolled hypertension
  • No history of other major medical illnesses including, but not limited to, any of the following:
  • Cardiac ischemia
  • Myocardial infarction
  • Major cardiac arrhythmias
  • Inflammatory bowel disorders
  • No other prior malignancy except for previously treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 3 years
  • No significant psychiatric disease that, in the opinion of the principal investigator, would preclude giving adequate informed consent or render immunotherapy unsafe
  • PRIOR CONCURRENT THERAPY:
  • No prior treatment for RCC except sunitinib malate
  • Patients may have progressed or have been intolerant to sunitinib malate
  • No prior systemic treatment for metastatic disease (other than sunitinib malate)
  • No prior organ allografts
  • At least 2 weeks since prior laparoscopic/robotic surgery
  • At least 4 weeks since prior open nephrectomy
  • More than 4 weeks since prior and no concurrent radiotherapy or other surgery
  • More than 4 weeks since prior systemic steroids
  • More than 2 weeks since prior topical, injected, or inhaled steroids
  • No concurrent steroid therapy
  • No concurrent Hypericum perforatum (St. John's wort)

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: A Phase I Study Of Peginterferon Alfa-2b (PEG-INTRON) With Sorafenib (Nexavar) In Patients With Unresectable Or Metastatic Clear Cell Renal Carcinoma (RCC).

RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stop the growth of kidney cancer by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b together with sorafenib may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of PEG-interferon alfa-2b and sorafenib in treating patients with unresectable or metastatic kidney cancer.

Read the detailed description

OBJECTIVES:

Primary

  • To determine the maximum tolerated dose and toxicity of PEG-interferon alfa-2b and sorafenib tosylate in patients with unresectable or metastatic clear cell renal cell carcinoma.

Secondary

  • To determine the progression-free survival of patients treated with this regimen.
  • To evaluate, in a preliminary manner, the response rate and overall survival of patients treated with this regimen.
  • To evaluate the activation of interferon-induced transcription factors in immune cell subsets (including regulatory T cells [T regs]) using a novel flow cytometric assay and correlate this information with clinical outcome.
  • To measure circulating levels of IFN-γ and IL-5 for determination of Th1/Th2 status and CD4+, CD25+, and FoxP3 cell number (T regs) in peripheral blood.

OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously on days 1, 8, 15, 22, 29, 36, 43, and 50. Patients also receive oral sorafenib tosylate 2-3 times daily on days 15-56 of course 1 and on days 1-56 of all subsequent courses. Courses repeat every 56 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and periodically during study for correlative laboratory studies. Peripheral blood mononuclear cells are analyzed for STAT proteins (STAT1, STAT2, STAT3, STAT4, STAT5) and CD4+, CD25+, and FoxP3 regulatory T cells by flow cytometric assays. Samples are also analyzed for the presence of VEGF, VEGFR, IFN-γ, and IL-5 by ELISA assays; baseline expression of Jak-STAT signaling intermediates (Jak1, Tyk2, IFNAR, and IRF9) by immunoblot analysis; and interferon-stimulated gene expression by real time PCR and RT-PCR analysis.

After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Conditions
Kidney Cancer
Being tested
PEG-interferon alfa-2b, Sorafenib, gene expression analysis, polymerase chain reaction, reverse transcriptase-polymerase chain reaction
Keywords
clear cell renal cell carcinoma, stage III renal cell cancer, stage IV renal cell cancer
Medical subject headings
Kidney Neoplasms, Carcinoma, Renal Cell

What participants receive

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

  • PEG-interferon alfa-2bBiological

    Also called peginterferon alfa-2b

    administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.

  • SorafenibDrug

    Also called Nexavar, BAY 54-9085 is the tosylate salt of BAY 43-9006

  • gene expression analysisGenetic

  • polymerase chain reactionGenetic

  • reverse transcriptase-polymerase chain reactionGenetic

  • flow cytometryOther

  • immunoenzyme techniqueOther

  • laboratory biomarker analysisOther

Study groups in NCT00589550
Study groupRoleWhat they receive
Peginterferon alfa-2bExperimentalPeginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
Receives: Biological: PEG-interferon alfa-2b; Drug: Sorafenib; Genetic: gene expression analysis; Genetic: polymerase chain reaction; Genetic: reverse transcriptase-polymerase chain reaction; Other: flow cytometry; Other: immunoenzyme technique; Other: laboratory biomarker analysis

What is being measured

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

  1. Maximum Tolerated Dose of PEG-interferon Alfa-2b and Sorafenib Tosylate

    Measured: up to 2 months

  2. Characterize the Toxicity of Peginterferon Alfa-2b and Sorafenib in Patients With Metastatic or Unresectable Clear Cell Renal Cell Carcinoma.

    Measured: up to 2 months

Secondary outcomes (5)

  1. Progression-free Survival of Patients Receiving Peginterferon Alfa-2b and Sorafenib.

    Measured: up to 1 year

  2. Response Rate of Patients Receiving Peginterferon Alfa-2b and Sorafenib.

    Measured: up to 1 year

  3. Overall Survival

    Measured: up to 1 year

  4. Activation of Interferon-induced Transcription Factors in Immune Cell Subsets by Flow Cytometry and Correlation of This Information With Clinical Outcome

    Measured: up to 1 year

  5. Circulating Levels of IFN-γ and IL-5 for Determination of Th1/Th2 Status and CD4+, CD25+, and FoxP3 Cell Number (T Regs) in Peripheral Blood

    Measured: Up to 1 year

Timeline

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

  1. First posted9 Jan 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionJan 2009
  4. Study completionJan 2009

Why it stopped: low accrual

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
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00589550
Sponsor's protocol ID
OSU-06113
Status last verified
Jun 2015
First submitted
5 Jan 2008
Last updated
8 Jun 2015
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PEG-interferon alfa-2b, Sorafenib and gene expression analysis in people with Kidney Cancer, run by Thomas Olencki at 1 site in United States.

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 47 inclusion and 0 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: stopped early, as of the sponsor's last update on 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Yes. Results are posted in the registry (first posted 8 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Tolerated Dose of PEG-interferon Alfa-2b and Sorafenib Tosylate (time frame: up to 2 months). The study lists 2 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 NCT00589550.

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 8 Jun 2015; AzTrials last refreshed its copy on 6 Nov 2026.

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