Kidney CancerPhase 2NCT00021021
RPI.4610 in Treating Patients With Metastatic Kidney Cancer
A Phase 2 study testing anti-FLT-1 ribozyme in people with Kidney Cancer, run by Ribozyome at 1 site in United States.
Trial summary
RATIONALE: RPI.4610 may stop the growth of metastatic kidney cancer by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of RPI.4610 in treating patients who have metastatic kidney cancer. 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?
- anti-FLT-1 ribozyme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Feb 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
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically confirmed clear cell renal cell cancer Stage IV Measurable disease Bone metastases may not be only measurable lesions Failed prior interleukin-2 (IL-2) therapy (with or without interferon) or ineligible or intolerant of IL-2 Prior nephrectomy (radical, partial, or laparoscopic) at least 4 weeks ago No CNS metastases on CT scan or MRI of head
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin greater than 9.5 g/dL No history of bleeding disorder Hepatic: AST or ALT no greater than 3 times upper limit of normal (ULN) Bilirubin no greater than 1.5 times ULN (unless history of Gilbert's syndrome) Alkaline phosphatase no greater than 2.5 times ULN PT no greater than 15 sec INR no greater than 1.5 No history of cirrhosis Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease No uncontrolled hypertension, defined as newly diagnosed but untreated or treated but with diastolic blood pressure at least 95 mmHg or systolic blood pressure at least 160 mmHg Other: HIV negative No systemic infection requiring antibiotics within the past 28 days No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No alcohol or drug abuse within the past 2 years No other medical or psychiatric condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after study
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 4 weeks since prior IL-2 At least 6 months since prior biotherapy for metastases (e.g., vaccines, matrix metalloproteinase inhibitors, or antibody therapy) No prior antiangiogenic agent, including thalidomide, or experimental antiangiogenic agents No concurrent immunotherapy No other concurrent biotherapy Chemotherapy: No prior chemotherapy for metastatic renal cell cancer No concurrent chemotherapy Endocrine therapy: No concurrent estrogens or other hormonal therapy including androgens Concurrent replacement doses of steroids allowed provided stable for the past 28 doses Radiotherapy: At least 8 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior major surgery Other: At least 4 weeks since prior investigational drugs No other concurrent investigational drugs No concurrent immunosuppressive medications No concurrent warfarin, heparin, low molecular weight heparin, or other anticoagulant agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
About this study
Official title: A Phase II, Open-Label, Multicenter Trial of Angiozyme in Subjects With Metastatic Renal Cell Cancer
RATIONALE: RPI.4610 may stop the growth of metastatic kidney cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of RPI.4610 in treating patients who have metastatic kidney cancer.
Read the detailed description
OBJECTIVES: I. Determine the response rate of patients with metastatic renal cell cancer treated with RPI.4610. II. Determine the percentage of these patients with stable disease at 16 weeks after starting treatment with this drug. III. Assess the safety and tolerability of this drug in these patients.
OUTLINE: This is a multicenter study. Patients receive RPI.4610 subcutaneously daily. Treatment continues for 16 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may continue treatment after 16 weeks. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
- Conditions
- Kidney Cancer
- Being tested
- anti-FLT-1 ribozyme
- Keywords
- stage IV renal cell cancer, clear cell renal cell carcinoma
- 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.
anti-FLT-1 ribozymeBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2004 (estimated)
- Study startSep 2001
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney 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
Sponsor and investigators
- Lead sponsor
- Ribozyome
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert A. Figlin, MD, FACP, Study chair, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00021021
- Sponsor's protocol ID
- CDR0000068739
- Other IDs
- UCLA-001201501, RPI-0004, NCI-G01-1975
- Status last verified
- May 2002
- First submitted
- 11 Jul 2001
- Last updated
- 26 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Multicenter Trial of Angiozyme in Subjects With Metastatic Renal Cell Cancer
- ClinicalTrials.gov ID
- NCT00021021
- Acronym / sponsor ID
- CDR0000068739
- Conditions
- Kidney Cancer
- Keywords
- stage IV renal cell cancer, clear cell renal cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- RibozyomeIndustry (pharma, biotech, devices)
- Study start
- Sep 2001
- Study completion
- Feb 2004 (actual)
- First posted
- 16 Feb 2004 (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: RPI.4610 may stop the growth of metastatic kidney cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of RPI.4610 in treating patients who have metastatic kidney cancer.
Detailed description
OBJECTIVES: I. Determine the response rate of patients with metastatic renal cell cancer treated with RPI.4610. II. Determine the percentage of these patients with stable disease at 16 weeks after starting treatment with this drug. III. Assess the safety and tolerability of this drug in these patients.
OUTLINE: This is a multicenter study. Patients receive RPI.4610 subcutaneously daily. Treatment continues for 16 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may continue treatment after 16 weeks. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| anti-FLT-1 ribozyme | Biological | – |
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 26 Mar 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.
Robert A. Figlin, MD, FACP study chair
Jonsson Comprehensive 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 anti-FLT-1 ribozyme in people with Kidney Cancer, run by Ribozyome 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 26 Mar 2013. 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 26 Mar 2013.