Renal CancerPhase 2NCT00293527
Interferon Alpha-2b (Intron A) for Metastatic or Unresectable Clear Cell Renal Carcinoma
A Phase 2 study testing Interferon Alpha-2b in people with Renal Cancer, run by Ohio State University Comprehensive Cancer Center.
Trial summary
This study will determine the response rate of daily low dose interferon-alpha-2b in patients with metastatic or unresectable clear cell renal cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cancer
- What is being tested?
- Interferon Alpha-2b
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Nov 2006
- Phase
- Phase 2
- 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
- Metastatic or unresectable clear cell renal cell carcinoma
- Measurable disease
Who cannot join
- Prior interferon therapy
- More than 3 prior therapy regimens
About this study
Official title: A Phase II Dose Escalation Study of Continuous Daily Subcutaneous Administration of Interferon Alpha-2b in Patients With Metastatic or Unresectable Clear Cell Renal Cell Carcinoma
This study will determine the response rate of daily low dose interferon-alpha-2b in patients with metastatic or unresectable clear cell renal cell carcinoma.
Read the detailed description
Rationale: Interferon has long been used as a therapy for renal cell carcinoma. However, optimal dosing schedules have not been identified and patients have been relegated to receiving the highest possible doses for prolonged periods of time. This high-dose approach often leads to serious adverse effects from toxicity that limits the usefulness and patient tolerance of this treatment. No formal study has determined the relationship if any between the maximal tolerated dose (MTD) and the biological effective dose of interferon alpha-2b. The current study seeks to fill that gap by gathering research information about different doses of interferon alpha-2b and correlating with measurements of JAK/STAT in the blood. Validation of correlative studies to determine optimum biologic dosing are needed so that therapy may be adjusted appropriately rather then the current approach of maximizing dose. In addition, a trial of low dose daily administered interferon-2b has not been carried out in the current era with refined histologic classification and modern CT imaging scanning. As this therapy potentially has wide applicability, definite response rates need to be documented.
Purpose: The purpose of this study is to assess the response rate of daily low dose interferon-2b in patients with metastatic or unresectable clear cell renal carcinoma. The duration of the response and overall survival will be determined in study participants. This study will also evaluate JAK/STAT, two types of kinases or enzymes involved in an intracellular signaling process associated with cancer growth, in peripheral blood mononuclear cells over the course of interferon alpha-2b dose escalation. Researchers will examine in a preliminary manner the correlation between clinical response, toxicity, and JAK/STAT signal transduction. Progression free survival and rate of stable disease will also be determined in a preliminary manner.
Treatment: Study participants will receive interferon alpha-2b. This drug will be self-administered daily through injections into the skin. The dose level of interferon alpha-2b will be increased each week into study treatments. For the first three weeks and approximately monthly thereafter, patients will have blood drawn three hours following interferon alpha-2b administration to measure JAK/STAT. Toxicity from study treatments will be closely monitored in patients during clinics visits. Supportive care therapies will be given throughout the study. Treatments will be discontinued due to disease growth or unacceptable side effects.
- Conditions
- Renal Cancer
- Being tested
- Interferon Alpha-2b
- Keywords
- Metastatic
- Medical subject headings
- Kidney Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon Alpha-2bDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2006 (estimated)
- Study completionNov 2006
Why it stopped: Withdrawn in October 2006, no longer of interest
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Olencki, Ohio State University Comprehensive Cancer Center
- Investigators
- Thomas Olencki, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293527
- Sponsor's protocol ID
- OSU-05030
- Status last verified
- May 2013
- First submitted
- 15 Feb 2006
- Last updated
- 23 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Dose Escalation Study of Continuous Daily Subcutaneous Administration of Interferon Alpha-2b in Patients With Metastatic or Unresectable Clear Cell Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00293527
- Acronym / sponsor ID
- OSU-05030
- Conditions
- Renal Cancer
- Keywords
- Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn in October 2006, no longer of interest
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study completion
- Nov 2006
- First posted
- 17 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the response rate of daily low dose interferon-alpha-2b in patients with metastatic or unresectable clear cell renal cell carcinoma.
Detailed description
Rationale: Interferon has long been used as a therapy for renal cell carcinoma. However, optimal dosing schedules have not been identified and patients have been relegated to receiving the highest possible doses for prolonged periods of time. This high-dose approach often leads to serious adverse effects from toxicity that limits the usefulness and patient tolerance of this treatment. No formal study has determined the relationship if any between the maximal tolerated dose (MTD) and the biological effective dose of interferon alpha-2b. The current study seeks to fill that gap by gathering research information about different doses of interferon alpha-2b and correlating with measurements of JAK/STAT in the blood. Validation of correlative studies to determine optimum biologic dosing are needed so that therapy may be adjusted appropriately rather then the current approach of maximizing dose. In addition, a trial of low dose daily administered interferon-2b has not been carried out in the current era with refined histologic classification and modern CT imaging scanning. As this therapy potentially has wide applicability, definite response rates need to be documented.
Purpose: The purpose of this study is to assess the response rate of daily low dose interferon-2b in patients with metastatic or unresectable clear cell renal carcinoma. The duration of the response and overall survival will be determined in study participants. This study will also evaluate JAK/STAT, two types of kinases or enzymes involved in an intracellular signaling process associated with cancer growth, in peripheral blood mononuclear cells over the course of interferon alpha-2b dose escalation. Researchers will examine in a preliminary manner the correlation between clinical response, toxicity, and JAK/STAT signal transduction. Progression free survival and rate of stable disease will also be determined in a preliminary manner.
Treatment: Study participants will receive interferon alpha-2b. This drug will be self-administered daily through injections into the skin. The dose level of interferon alpha-2b will be increased each week into study treatments. For the first three weeks and approximately monthly thereafter, patients will have blood drawn three hours following interferon alpha-2b administration to measure JAK/STAT. Toxicity from study treatments will be closely monitored in patients during clinics visits. Supportive care therapies will be given throughout the study. Treatments will be discontinued due to disease growth or unacceptable side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Metastatic or unresectable clear cell renal cell carcinoma
- Measurable disease
Key exclusion criteria (2 listed)
- Prior interferon therapy
- More than 3 prior therapy regimens
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon Alpha-2b | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Olencki principal investigator
Ohio State University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interferon Alpha-2b in people with Renal Cancer, run by Ohio State University Comprehensive Cancer Center.
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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 23 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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.
Where can I read the original study information?
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 23 May 2013.