Kidney CancerPhase 2NCT00090870
PEG-Interferon Alfa-2b, Sargramostim, and Thalidomide in Treating Patients With Metastatic Kidney Cancer
A Phase 2 study testing PEG-interferon alfa-2b, GM-CSF and thalidomide in people with Kidney Cancer, run by Medical University of South Carolina at 1 site in United States.
Trial summary
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- PEG-interferon alfa-2b, GM-CSF and thalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2002to Mar 2010
- Phase
- Phase 2
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed renal cell carcinoma
- Metastatic disease
- Measurable disease
- Unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan or MRI
- Histologic confirmation required if measurable disease is confined to a solitary lesion
- The following are not considered measurable disease:
- Bone disease only
- Pleural or peritoneal metastases
- CNS lesions
- Irradiated lesions unless disease progression was documented after prior radiotherapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 mg/dL
- No decompensated liver disease
Renal
- Creatinine ≤ 2.0 mg/dL
Immunologic
- No known or suspected hypersensitivity to interferon alfa or to any excipient or vehicle included in the formulation or delivery system
- No history of autoimmune disease
- No autoimmune hepatitis
- No immunosuppressed transplantation recipients
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 effective methods of contraception 4 weeks before, during, and for 4 weeks after study participation
- No pre-existing thyroid abnormalities for which thyroid function cannot be maintained in the normal range
- No severe psychiatric condition or disorder, including suicidal ideation or attempt
- No other active malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior immunotherapy
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy
Surgery
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: A Phase II Study Of Peg-Intron, GM-CSF And Thalidomide In Metastatic Renal Cell Carcinoma
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining PEG-interferon alfa-2b with sargramostim and thalidomide may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with sargramostim and thalidomide works in treating patients with metastatic kidney cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the response to PEG-interferon alfa-2b, sargramostim (GM-CSF), and thalidomide in patients with metastatic renal cell carcinoma.
Secondary
- Determine duration of response in patients treated with this regimen.
- Determine the tolerance to and toxicity of this regimen in these patients.
- Determine the median and progression-free survival of patients treated with this regimen.
OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously (SC) on days 1 and 8, sargramostim (GM-CSF) SC on days 1-10, and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
- Conditions
- Kidney Cancer
- Being tested
- PEG-interferon alfa-2b, GM-CSF, thalidomide
- Keywords
- 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
Peg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days.
GM-CSFBiological
GM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle
thalidomideDrug
200mg daily by mouth
| Study group | Role | What they receive |
|---|---|---|
| PEG-Intron, BM-CSF and thalidomide | Experimental | Not described Receives: Biological: PEG-interferon alfa-2b; Biological: GM-CSF; Drug: thalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
To define the response rate in metastatic renal cell carcinoma patients receiving Peg-Intron, GM-CSF and thalidomide
Measured: while on study, every 4 cycles; while off study, every 3 months for 1 year, then every 6 month for 2 years, then every year
Secondary outcomes (3)
Duration of Response
Measured: time from registration to the time of progressive disease among patients who achieve at least a partial response to treatment.
Frequency of Adverse Events Assessed by NCI CTC Version 2
Measured: From the first day of treatment until the end of treatment visit, an average of 6 months
Progression-free Survival
Measured: From registration until diease progression or death, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2004 (estimated)
- Study startApr 2002
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: Pharmaceutical collaborator pulled funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uzair B. Chaudhary, MD, Study chair, Medical University of South CarolinaGustavo Leone, Study chair, Medical University of South Carolina, Hollings Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090870
- Sponsor's protocol ID
- CDR0000378049
- Other IDs
- MUSC-100614, CELGENE-MUSC-100614, MUSC-HR-10423
- Status last verified
- Jun 2018
- First submitted
- 7 Sep 2004
- Last updated
- 12 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of Peg-Intron, GM-CSF And Thalidomide In Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00090870
- Acronym / sponsor ID
- CDR0000378049
- Conditions
- Kidney Cancer
- Keywords
- stage IV renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pharmaceutical collaborator pulled funding.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Apr 2002
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 8 Sep 2004 (estimated)
- Results
- Posted 12 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining PEG-interferon alfa-2b with sargramostim and thalidomide may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with sargramostim and thalidomide works in treating patients with metastatic kidney cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the response to PEG-interferon alfa-2b, sargramostim (GM-CSF), and thalidomide in patients with metastatic renal cell carcinoma.
Secondary
- Determine duration of response in patients treated with this regimen.
- Determine the tolerance to and toxicity of this regimen in these patients.
- Determine the median and progression-free survival of patients treated with this regimen.
OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously (SC) on days 1 and 8, sargramostim (GM-CSF) SC on days 1-10, and oral thalidomide once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEG-Intron, BM-CSF and thalidomide | Experimental | Biological: PEG-interferon alfa-2b, Biological: GM-CSF, Drug: thalidomide |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| PEG-interferon alfa-2bPeg-Intron 1ug/kg Subcutaneous on day 1 and day 8 of each cycle. Each cycle is 21 days. | Biological | PEG-Intron, BM-CSF and thalidomide |
| GM-CSFGM-CSF 250 ug/m2 subcutaneously daily from days 1-10 or each 21 day Peg-Intron cycle | Biological | PEG-Intron, BM-CSF and thalidomide |
| thalidomide200mg daily by mouth | Drug | PEG-Intron, BM-CSF and thalidomide |
Primary outcome
Response Rate
Time frame: while on study, every 4 cycles; while off study, every 3 months for 1 year, then every 6 month for 2 years, then every year
To define the response rate in metastatic renal cell carcinoma patients receiving Peg-Intron, GM-CSF and thalidomide
3 secondary outcomes
Duration of Response
Time frame: time from registration to the time of progressive disease among patients who achieve at least a partial response to treatment.
Frequency of Adverse Events Assessed by NCI CTC Version 2
Time frame: From the first day of treatment until the end of treatment visit, an average of 6 months
Progression-free Survival
Time frame: From registration until diease progression or death, whichever comes first.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Uzair B. Chaudhary, MD study chair
Medical University of South Carolina
Gustavo Leone study chair
Medical University of South Carolina, Hollings Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PEG-interferon alfa-2b, GM-CSF and thalidomide in people with Kidney Cancer, run by Medical University of South Carolina 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?
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 12 Jul 2018. 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 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?
Yes. Results are posted in the registry (first posted 12 Jul 2018). 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?
Response Rate (time frame: while on study, every 4 cycles; while off study, every 3 months for 1 year, then every 6 month for 2 years, then every year). It is what the study was designed to measure, not a finding.
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 12 Jul 2018.