Recurrent Renal Cell CancerPhase 2NCT00354250
Ispinesib in Treating Patients With Metastatic or Unresectable Kidney Cancer
A Phase 2 study testing ispinesib in people with Recurrent Renal Cell Cancer and Stage III Renal Cell Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase II trial is studying how well ispinesib works in treating patients with metastatic or unresectable kidney cancer. Ispinesib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Recurrent Renal Cell Cancer, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer
- What is being tested?
- ispinesib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Feb 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have histologically or cytologically confirmed renal cell carcinoma which is metastatic (M1); histopathology is not restricted; patients with unresectable primary tumor (but MO) are also eligible
- Patients must have measurable disease; x-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; x-rays, scans or physical examinations for non-measurable disease must have been completed within 42 days prior to registration
- Patients with metastatic disease who have a resectable primary tumor and are deemed a surgical candidate may have undergone resection and have recovered from surgery; at least 28 days must have elapsed since surgery and patient must have recovered from any adverse effects of surgery
- Patients must have discontinued therapy due to toxicity or demonstrated progression of disease following a minimum of one prior therapy; prior therapies may include: immunotherapy with either interferon (IFN) and/or Interleukin-2 (IL-2) or prior anti-angiogenesis agents; at least 28 days must have elapsed since the last treatment; patients must have recovered from any adverse effects of prior therapy
- Patients may have received prior radiation therapy; at least 21 days must have elapsed since completion of prior radiation therapy; patients must have recovered from all associated toxicities at the time of registration
- Patients may not have received prior tubule, DNA, or mitosis targeting agents for the treatment of renal cell carcinoma
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- Patients must have a ECOG performance status of 0 - 2
- Pregnant or nursing women may not participate in this trial; women and men of reproductive potential must have agreed to use an effective contraceptive method; women of child-bearing potential must have a negative urine pregnancy test
- Patients with a history of brain metastases or who currently have treated or untreated brain metastases are not eligible; patients with clinical evidence of brain metastases must have a brain CT or MRI negative for metastatic disease within 56 days prior to registration
- Absolute granulocyte count (AGC) ≥ 1,500 cells/mm3, hemoglobin ≥ 9 mg/dl, and a platelet count ≥ 100,000 cells/mm3 within 14 days prior to registration
- Patients must have a total bilirubin < 2 mg/dl obtained within 14 days prior to registration
- Patients must have SGOT and SGPT =< 2.5 x institutional upper limit of normal within 14 days prior to registration
- Patients must have a serum creatinine =< 2.0 or a calculated creatinine clearance >= 40 mL/min for patients with creatinine levels above institutional normal; this must be obtained within 14 days prior to registration
- Patients must have a corrected QT interval less than 0.47 seconds
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
- Prohibited medications; SB-715992 is a moderate to significant in vitro inhibitor of CYP3A4; the following lists of medications/substances are moderate to significant inhibitors/inducers of CYP3A4 that, if administered concomitantly with SB-715992, may alter study drug exposure; the use of these medications/ substances within 14 days (=< 6 months for amiodarone) prior to the administration of the first dose of SB-715992 through discontinuation from the study is prohibited
- Inhibitors of CYP3A4:
- Antibiotics: Clarithromycin, erythromycin, troleandomycin, rifabutin, rifapentine
- Antifungals: itraconazole, ketoconazole, fluconazole (doses > 200 mg/day), voriconazole
- Antidepressants: nefazodone, fluovoxamine
- Calcium channel blockers: verapamil, diltiazem
- Miscellaneous: amiodarone*, bitter orange
- Use of amiodarone within 6 months prior to the administration of the first dose of SB-715992 is prohibited.
- Inducers of CYP3A4:
- Anticonvulsants: phenytoin, carbamazepine, phenobarbital, oxcarbazepine
- Antibiotics: rifampin, rifabutin, rifapentine
- Miscellaneous: St. John's Wort, modafinil
- Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to SB-715992
- Patients must not have any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/ social situations that would limit compliance with study requirements
- Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy; therefore, HIV-positive patients receiving combination anti-retroviral therapy are not eligible because of possible pharmacokinetic interactions with SB-715992
- No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637-1470
About this study
Official title: A Phase II Study of SB-715992 (NSC-727990, IND-70273) in Advanced Renal Cell Cancer
This phase II trial is studying how well ispinesib works in treating patients with metastatic or unresectable kidney cancer. Ispinesib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the efficacy of SB-715992 in patients with advanced renal cell cancer who have received at least one prior therapy. This will be achieved by a multi-center, single arm phase II study to evaluate the proportion of patients who achieve a complete or partial response with this agent.
SECONDARY OBJECTIVES:
- To assess the overall survival. II. To assess the time to progression. III. To evaluate the qualitative and quantitative toxicities of this regimen.
OUTLINE: This is a multicenter study.
Patients receive ispinesib (SB-715992) IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 3 years.
- Being tested
- ispinesib
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ispinesibDrug
Also called CK0238273, SB-715992
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (ispinesib) | Experimental | Patients receive ispinesib (SB-715992) IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: ispinesib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate defined as the proportion of patients who achieve a complete or partial response with ispinesib evaluated per RECIST
If the response rate is 30% or more, further study would be proposed based on the estimates produced in this trial. Will be presented along with 95% confidence intervals.
Measured: Up to 4 years
Secondary outcomes (3)
Overall survival
Will be presented in Kaplan-Meier plots and the median values of each (if reached) will be reported.
Measured: Up to 4 years
Time to progression
Will be presented in Kaplan-Meier plots and the median values of each (if reached) will be reported.
Measured: Up to 4 years
Qualitative and quantitative toxicities of this regimen graded according to NCI CTCAE
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startMay 2006
- Primary completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Walter Stadler, Principal investigator, University of Chicago Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354250
- Sponsor's protocol ID
- NCI-2012-02928
- Other IDs
- 14577A, N01CM62201
- Status last verified
- Jun 2013
- First submitted
- 19 Jul 2006
- Last updated
- 5 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of SB-715992 (NSC-727990, IND-70273) in Advanced Renal Cell Cancer
- ClinicalTrials.gov ID
- NCT00354250
- Acronym / sponsor ID
- NCI-2012-02928
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- May 2006
- Primary completion
- Feb 2007 (actual)
- First posted
- 20 Jul 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 phase II trial is studying how well ispinesib works in treating patients with metastatic or unresectable kidney cancer. Ispinesib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVES:
- To assess the efficacy of SB-715992 in patients with advanced renal cell cancer who have received at least one prior therapy. This will be achieved by a multi-center, single arm phase II study to evaluate the proportion of patients who achieve a complete or partial response with this agent.
SECONDARY OBJECTIVES:
- To assess the overall survival. II. To assess the time to progression. III. To evaluate the qualitative and quantitative toxicities of this regimen.
OUTLINE: This is a multicenter study.
Patients receive ispinesib (SB-715992) IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (ispinesib) | Experimental | Drug: ispinesibPatients receive ispinesib (SB-715992) IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (31 listed)
- Patients must have histologically or cytologically confirmed renal cell carcinoma which is metastatic (M1); histopathology is not restricted; patients with unresectable primary tumor (but MO) are also eligible
- Patients must have measurable disease; x-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; x-rays, scans or physical examinations for non-measurable disease must have been completed within 42 days prior to registration
- Patients with metastatic disease who have a resectable primary tumor and are deemed a surgical candidate may have undergone resection and have recovered from surgery; at least 28 days must have elapsed since surgery and patient must have recovered from any adverse effects of surgery
- Patients must have discontinued therapy due to toxicity or demonstrated progression of disease following a minimum of one prior therapy; prior therapies may include: immunotherapy with either interferon (IFN) and/or Interleukin-2 (IL-2) or prior anti-angiogenesis agents; at least 28 days must have elapsed since the last treatment; patients must have recovered from any adverse effects of prior therapy
- Patients may have received prior radiation therapy; at least 21 days must have elapsed since completion of prior radiation therapy; patients must have recovered from all associated toxicities at the time of registration
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ispinesibAlso: CK0238273, SB-715992Given IV | Drug | Treatment (ispinesib) |
Primary outcome
Response rate defined as the proportion of patients who achieve a complete or partial response with ispinesib evaluated per RECIST
Time frame: Up to 4 years
If the response rate is 30% or more, further study would be proposed based on the estimates produced in this trial. Will be presented along with 95% confidence intervals.
3 secondary outcomes
Overall survival
Time frame: Up to 4 years
Time to progression
Time frame: Up to 4 years
Qualitative and quantitative toxicities of this regimen graded according to NCI CTCAE
Time frame: Up to 4 years
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 5 Jun 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.
Walter Stadler principal investigator
University of Chicago 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 ispinesib in people with Recurrent Renal Cell Cancer and Stage III 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?
The sponsor lists 31 inclusion and 0 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: finished, as of the sponsor's last update on 5 Jun 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.
What does the primary outcome measure?
Response rate defined as the proportion of patients who achieve a complete or partial response with ispinesib evaluated per RECIST (time frame: Up to 4 years). 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 5 Jun 2013.