Stage IV Renal Cell CancerPhase 2NCT00019539
Monoclonal Antibody Therapy in Treating Patients With Advanced Kidney Cancer
A Phase 2 study testing bevacizumab and thalidomide in people with Stage IV Renal Cell Cancer and Recurrent Renal Cell Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them. PURPOSE: Randomized phase II trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have advanced kidney cancer that cannot be surgically removed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Renal Cell Cancer, Recurrent Renal Cell Cancer
- What is being tested?
- bevacizumab and thalidomide
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Nov 1998to Nov 2004
- 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
- Adult, Older adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Histologically proven unresectable advanced renal cell cancer Measurable disease Must have received or not be a suitable candidate for interleukin-2 therapy No papillary or collecting duct renal cell cancer No CNS metastases --Prior/Concurrent Therapy-- Biologic therapy: See Disease Characteristics No prior thalidomide At least 4 weeks since other prior biologic therapy No other concurrent biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior endocrine therapy No concurrent corticosteroid therapy Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: WBC at least 1,000/mm3 Platelet count at least 75,000/mm3 No coagulation disorder, active bleeding, or wound healing problem Hepatic: Total bilirubin no greater than 2.0 mg/dL (for patients with Gilbert's disease, direct bilirubin less than 0.5 mg/dL) SGOT or SGPT no greater than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No coronary artery disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No clinically evident preexisting peripheral neuropathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Randomized Study of Monoclonal Antibody VEGF in Patients With Unresectable Advanced Renal Cell Cancer
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them.
PURPOSE: Randomized phase II trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have advanced kidney cancer that cannot be surgically removed.
Read the detailed description
OBJECTIVES: I. Determine the effect of monoclonal antibody VEGF on time to progression, angiogenesis, and overall survival in patients with unresectable advanced renal cell cancer.
II. Evaluate serum antibody levels and biologically active vascular endothelial growth factor levels in the plasma of patients treated with this regimen.
III. Evaluate the toxicity of this regimen in these patients.
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by prior interleukin-2 therapy (yes vs no).
Patients are randomized to receive either placebo or one of two doses of monoclonal antibody VEGF. Following an initial loading dose, patients receive one dose of the study drug intravenously every 2 weeks for up to 2 years in the absence of disease progression. Patients who are given placebo and experience disease progression are offered monoclonal antibody VEGF and thalidomide if there are no contraindications.
PROJECTED ACCRUAL:
A total of 150 patients will be accrued for this study over 2 years.
- Being tested
- bevacizumab, thalidomide
- Keywords
- adult solid tumor, body system/site cancer, cancer, kidney tumor, kidney/urinary cancer, recurrent renal cell cancer, renal cell cancer, solid tumor, stage IV renal cell cancer, stage, renal cell cancer
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasms, Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabDrug
thalidomideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startNov 1998
- Study completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IV Renal Cell CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- James Chung-Yin Yang, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00019539
- Sponsor's protocol ID
- CDR0000066669
- Other IDs
- NCI-98-C-0159, NCI-T98-0035
- Status last verified
- Feb 2024
- First submitted
- 9 Jan 2009
- Last updated
- 4 Mar 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Study of Monoclonal Antibody VEGF in Patients With Unresectable Advanced Renal Cell Cancer
- ClinicalTrials.gov ID
- NCT00019539
- Acronym / sponsor ID
- CDR0000066669
- Keywords
- adult solid tumor, body system/site cancer, cancer, kidney tumor, kidney/urinary cancer, recurrent renal cell cancer, renal cell cancer, solid tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Nov 1998
- Study completion
- Nov 2004 (actual)
- First posted
- 13 Jan 2009 (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.
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them.
PURPOSE: Randomized phase II trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have advanced kidney cancer that cannot be surgically removed.
Detailed description
OBJECTIVES: I. Determine the effect of monoclonal antibody VEGF on time to progression, angiogenesis, and overall survival in patients with unresectable advanced renal cell cancer.
II. Evaluate serum antibody levels and biologically active vascular endothelial growth factor levels in the plasma of patients treated with this regimen.
III. Evaluate the toxicity of this regimen in these patients.
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by prior interleukin-2 therapy (yes vs no).
Patients are randomized to receive either placebo or one of two doses of monoclonal antibody VEGF. Following an initial loading dose, patients receive one dose of the study drug intravenously every 2 weeks for up to 2 years in the absence of disease progression. Patients who are given placebo and experience disease progression are offered monoclonal antibody VEGF and thalidomide if there are no contraindications.
PROJECTED ACCRUAL:
A total of 150 patients will be accrued for this study over 2 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- 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 |
|---|---|---|
| bevacizumab | Drug | – |
| thalidomide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
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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.
James Chung-Yin Yang study chair
National Cancer Institute (NCI)
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 bevacizumab and thalidomide in people with Stage IV Renal Cell Cancer and Recurrent Renal Cell Cancer, run by National Cancer Institute (NCI) 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: finished, as of the sponsor's last update on 4 Mar 2024. 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?
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.
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 4 Mar 2024.