Carcinoma, Renal CellPhase 2NCT00440973
Safety Study of Specific Tumor Target Drug Plus Immune System Therapy in Patients With Kidney Cancer
A Phase 2 study testing Bevacizumab and Interleukin-2 in people with Carcinoma, Renal Cell, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine if the combination of therapy to strengthen the immune system (Interleukin - 2) plus a specific tumor target therapy (Bevacizumab) can prolong the time between the start of treatment and disease progression, decrease tumor size, as well as determine if the combination therapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Bevacizumab and Interleukin-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Nov 2007
- 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
- Pathological proof of clear cell carcinoma (or mixed tumors ≥ 75% clear cell component)
- Evidence of measurable metastatic disease, no progression diseases or the patient's condition will not need radiotherapy in the next 4 weeks.
- Previous definitive radiotherapy to 1 metastatic site is acceptable
- At least 4 weeks have elapsed since radiation therapy
- Patients must be free of serious co-morbidity and have a life expectancy of ≥24 weeks
- Patients should have adequate physiologic reserves as evidence of adequate performance status, blood parameters, hepatic and kidney function, no evidence of active cardiac diseases and showing an acceptable function and adequate coagulation profile.
Who cannot join
- History of central nervous System metastases
- Known HIV positive
- Recent history of brain's vascular disease within 6 months; patients requiring regular antianginal therapy (coronary disease) or insufficient circulation in lower extremities are not eligible
- Active autoimmune disease
- Patients who have had steroid therapy in the past three weeks
- Patients taking concurrent anticancer drugs
Show all 15Show fewer
- Biphosphonates (Zometa) are not allowed, unless started 4 weeks prior to participation in the study
- Female patients pregnant or breast-feeding
- The patient has an unstable medical condition, such as uncontrolled Diabetes mellitus or Hypertension; active infections requiring systemic antibiotics, antivirals, or antifungal; clinical evidence of cardiac or pulmonary dysfunction including, uncontrolled arrhythmias, unstable coagulation disorders; or recent myocardial infarction (within 6 months)
- Any condition including abnormal laboratory results, that in the opinion of the investigator places the patient at an unacceptable risk if he/she participate in the study
- Prior malignancy (within the last 3 years), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patient has been - free for at least 3 years
- Uncontrolled Blood pressure > 150/100
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
- Minor surgery 7 days before day 0
- Serious, non healing wound, ulcer, or bone fracture; and,inability to accomplish the treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor College of Medicine - Methodist Hospital
Houston, Texas, 77030
About this study
Official title: Phase II Study of Interleukin- 2 and Bevacizumab in Patients With Progressive Metastatic Renal Cell Carcinoma
The purpose of this study is to determine if the combination of therapy to strengthen the immune system (Interleukin - 2) plus a specific tumor target therapy (Bevacizumab) can prolong the time between the start of treatment and disease progression, decrease tumor size, as well as determine if the combination therapy is safer and less toxic than the standard treatment for renal cell carcinoma.
Read the detailed description
The standard first-line treatment for patients with metastatic RCC is IL-2 at higher doses, but associated with higher frequency of toxicities. IL-2 given at lower doses have demonstrated similar results than higher doses but it requires further study. RCC is highly vascular and expresses high levels of VEGF. Bevacizumab is a monoclonal antibody directed against the Vascular Endothelial Growth Factor (VEGF) responsible for angiogenesis.
The study is designed to evaluate a response defined as time to progression, safety and toxicity in patients with metastatic renal cell carcinoma. Tissue correlation to evaluate the impact of vascular VEGF on clinical outcome will be retrospectively performed
- Conditions
- Carcinoma, Renal Cell
- Being tested
- Bevacizumab, Interleukin-2
- Keywords
- kidney cancer, M3thodist
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
monoclonal antibody with anti-angiogenesis properties used as chemotherapy
Interleukin-2Drug
Also called IL-2
immunotherapy - cytokine signaling molecule used as an immune system regulator to trigger T \& B lymphocyte proliferation
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Other | PI relocated, currently data is no longer available Receives: Drug: Bevacizumab; Drug: Interleukin-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to progression
currently data no longer available
Measured: During study (currently data no longer available)
Secondary outcomes (2)
Collect data on tumor responses produced by interleukin-2 and Bevacizumab
currently data no longer available
Measured: During study (currently data no longer available)
Evaluate safety and toxicity of the combination of interleukin-2 and Bevacizumab for patients with progressive metastatic renal cell carcinoma.
currently data no longer available
Measured: During study (currently data no longer available)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startOct 2006
- Primary completionOct 2007
- Study completionNov 2007
Why it stopped: contract issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Robert J. Amato, D.O., Principal investigator, Baylor College of Medicine - Methodist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440973
- Sponsor's protocol ID
- PAC IRB #03-0194-05
- Other IDs
- 16117
- Status last verified
- Mar 2016
- First submitted
- 23 Feb 2007
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Interleukin- 2 and Bevacizumab in Patients With Progressive Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00440973
- Acronym / sponsor ID
- PAC IRB #03-0194-05
- Conditions
- Carcinoma, Renal Cell
- Keywords
- kidney cancer, M3thodist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: contract issues
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Oct 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 27 Feb 2007 (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.
The purpose of this study is to determine if the combination of therapy to strengthen the immune system (Interleukin - 2) plus a specific tumor target therapy (Bevacizumab) can prolong the time between the start of treatment and disease progression, decrease tumor size, as well as determine if the combination therapy is safer and less toxic than the standard treatment for renal cell carcinoma.
Detailed description
The standard first-line treatment for patients with metastatic RCC is IL-2 at higher doses, but associated with higher frequency of toxicities. IL-2 given at lower doses have demonstrated similar results than higher doses but it requires further study. RCC is highly vascular and expresses high levels of VEGF. Bevacizumab is a monoclonal antibody directed against the Vascular Endothelial Growth Factor (VEGF) responsible for angiogenesis.
The study is designed to evaluate a response defined as time to progression, safety and toxicity in patients with metastatic renal cell carcinoma. Tissue correlation to evaluate the impact of vascular VEGF on clinical outcome will be retrospectively performed
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Other | Drug: Bevacizumab, Drug: Interleukin-2PI relocated, currently data is no longer available |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pathological proof of clear cell carcinoma (or mixed tumors ≥ 75% clear cell component)
- Evidence of measurable metastatic disease, no progression diseases or the patient's condition will not need radiotherapy in the next 4 weeks.
- Previous definitive radiotherapy to 1 metastatic site is acceptable
- At least 4 weeks have elapsed since radiation therapy
- Patients must be free of serious co-morbidity and have a life expectancy of ≥24 weeks
Key exclusion criteria (15 listed)
- History of central nervous System metastases
- Known HIV positive
- Recent history of brain's vascular disease within 6 months; patients requiring regular antianginal therapy (coronary disease) or insufficient circulation in lower extremities are not eligible
- Active autoimmune disease
- Patients who have had steroid therapy in the past three weeks
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 |
|---|---|---|
| BevacizumabAlso: Avastinmonoclonal antibody with anti-angiogenesis properties used as chemotherapy | Drug | treatment arm |
| Interleukin-2Also: IL-2immunotherapy - cytokine signaling molecule used as an immune system regulator to trigger T \& B lymphocyte proliferation | Drug | treatment arm |
Primary outcome
time to progression
Time frame: During study (currently data no longer available)
currently data no longer available
2 secondary outcomes
Collect data on tumor responses produced by interleukin-2 and Bevacizumab
Time frame: During study (currently data no longer available)
Evaluate safety and toxicity of the combination of interleukin-2 and Bevacizumab for patients with progressive metastatic renal cell carcinoma.
Time frame: During study (currently data no longer available)
Results and safety
The study was stopped early (reason given: contract issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Individual participant dataSharing planned: No
Related trials for Carcinoma, Renal Cell
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
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.
Robert J. Amato, D.O. principal investigator
Baylor College of Medicine - Methodist Hospital
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 Interleukin-2 in people with Carcinoma, Renal Cell, run by The Methodist Hospital Research Institute 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 6 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: stopped early, as of the sponsor's last update on 17 Mar 2016. 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 was stopped early (reason given: contract issues). Results are not available in the source record.
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?
time to progression (time frame: During study (currently data no longer available)). 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 17 Mar 2016.