Renal Cell CarcinomaNCT01404104
Neo-adjuvant Temsirolimus in Patients With Advanced Renal Cell Carcinoma
A study testing Temsirolimus (pre surgery) in people with Renal Cell Carcinoma, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
Temsirolimus is a drug that is being studied to possibly treat kidney cancer. It works by starving the cancer of nutrients, by cutting off the blood supply, which is hoping to shrink the cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Temsirolimus (pre surgery)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2008to Aug 2014
- Phase
- Interventional
- 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
- At least 18 years old and capable of giving informed consent.
- Patient has radiological evidence of RCC consisting of: CT scan with stage T2, T3, T3a, T4, or any stage T with N1/2 and/or metastatic disease.
- Patient is already having a nephrectomy.
- Adequate cardiac function as assessed by electrocardiogram (ECG).
- Patient is will to have a kidney biopsy at baseline/screening.
- Patient has scored a 0 or 1 on the ECOG.
- Patient is negative for HIV, Hepatitis B, Hepatitis C
- If patient is a woman of child-bearing potential, they have to have a negative pregnancy test.
Who cannot join
- Patient has stage T1 disease without metastases.
- Patient has abnormal laboratory values at screening within the following ranges:
- Absolute neutrophil count ≤1.5 x 10(9)/L; Platelet count ≤ 100 x 10(9)/L
- Leukocyte count ≤ 3 x 10(9)/L; Hemoglobin ≤ 80 g/L
- Serum creatinine ≥ 2.0 x the upper normal limit (UNL)
- Total bilirubin ≤ 1.5 x UNL; AST and ALT ≤ 3.0 x UNL
Show all 14Show fewer
- Fasting serum cholesterol ≤ 9.0 mmol/L
- Fasting serum triglycerides ≤ 5.0 mmol/L
- Patients with a known hyper-sensitivity to Temsirolimus.
- Other currently active malignancies.
- Currently taking any medications known to interfere with the metabolism of Temsirolimus.
- Patients receiving anticoagulation with warfarin.
- Patients with a history of pulmonary hypertension or interstitial lung disease.
- Unstable angina as judged by the primary investigator, or any recent MI in the last 180 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Neo-adjuvant Temsirolimus in Patients With Advanced Renal Cell Carcinoma Undergoing Definitive Therapy With Radical Nephrectomy, or Cytoreductive Nephrectomy: Analysis if Serum and Tissue Biomarkers
Temsirolimus is a drug that is being studied to possibly treat kidney cancer. It works by starving the cancer of nutrients, by cutting off the blood supply, which is hoping to shrink the cancer. This study will look at the experimental use of temsirolimus, 12 weeks prior to the surgical removal of the entire kidney or a portion of the kidney that is involved by the tumor.
Read the detailed description
This study will also find out whether or not there are certain biological factors that show up in patients during their treatment with this drug. This will be able to predict how their disease will respond to the therapy (biomarkers), and this will possibly allow anti-cancer therapies to be developed in the future to tailor to a patient's needs.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Temsirolimus (pre surgery)
- 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.
Temsirolimus (pre surgery)Drug
Also called Temsirolimus
Temsirolimus will be given to patients 12 weeks prior to surgery (with a one week off period right before the surgery date).
| Study group | Role | What they receive |
|---|---|---|
| Temsirolimus (pre-surgery) | Experimental | Not described Receives: Drug: Temsirolimus (pre surgery) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of change in response of primary tumor and metastases (if applicable)in participants.
Rate of Change in response of primary tumor and metastases (if applicable) to neo-adjuvant Temsirolimus in terms of tumour size and appearance (RECIST imaging response criteria) as determined by CT or MRI.
Measured: Baseline, Weeks 1-12, follow up every 3 months for years 1 and 2, and every 6 months for following three years (5 years in total).
Secondary outcomes (2)
Average time for disease progression.
Patients will be seen at baseline and 12 weeks prior to surgical removal of the entire kidney or a portion of the kidney involved by tumour. If there has been metastases then patients might remain on the study treatment with temsirolimus following the surgery, for a maximum of 24 months or until disease progression. The total duration of the study is up to 5 years.
Measured: At every visit; baseline, weekly visits, and follow-up.
Quality of life data
Measured: Baseline, weekly visits, follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startSep 2008
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, Pfizer
- Responsible party
- Principal investigator, Anil Kapoor, St. Joseph's Healthcare Hamilton
- Investigators
- Anil Kapoor, MD, Principal investigator, McMaster Institute of Urology - St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404104
- Sponsor's protocol ID
- IIS-003-09
- Status last verified
- Jul 2016
- First submitted
- 19 Jul 2011
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Neo-adjuvant Temsirolimus in Patients With Advanced Renal Cell Carcinoma Undergoing Definitive Therapy With Radical Nephrectomy, or Cytoreductive Nephrectomy: Analysis if Serum and Tissue Biomarkers
- ClinicalTrials.gov ID
- NCT01404104
- Acronym / sponsor ID
- IIS-003-09
- Conditions
- Renal Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- McMaster University, Pfizer
- Study start
- Sep 2008
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 27 Jul 2011 (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.
Temsirolimus is a drug that is being studied to possibly treat kidney cancer. It works by starving the cancer of nutrients, by cutting off the blood supply, which is hoping to shrink the cancer. This study will look at the experimental use of temsirolimus, 12 weeks prior to the surgical removal of the entire kidney or a portion of the kidney that is involved by the tumor.
Detailed description
This study will also find out whether or not there are certain biological factors that show up in patients during their treatment with this drug. This will be able to predict how their disease will respond to the therapy (biomarkers), and this will possibly allow anti-cancer therapies to be developed in the future to tailor to a patient's needs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temsirolimus (pre-surgery) | Experimental | Drug: Temsirolimus (pre surgery) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least 18 years old and capable of giving informed consent.
- Patient has radiological evidence of RCC consisting of: CT scan with stage T2, T3, T3a, T4, or any stage T with N1/2 and/or metastatic disease.
- Patient is already having a nephrectomy.
- Adequate cardiac function as assessed by electrocardiogram (ECG).
- Patient is will to have a kidney biopsy at baseline/screening.
Key exclusion criteria (14 listed)
- Patient has stage T1 disease without metastases.
- Patient has abnormal laboratory values at screening within the following ranges:
- Absolute neutrophil count ≤1.5 x 10(9)/L; Platelet count ≤ 100 x 10(9)/L
- Leukocyte count ≤ 3 x 10(9)/L; Hemoglobin ≤ 80 g/L
- Serum creatinine ≥ 2.0 x the upper normal limit (UNL)
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 |
|---|---|---|
| Temsirolimus (pre surgery)Also: TemsirolimusTemsirolimus will be given to patients 12 weeks prior to surgery (with a one week off period right before the surgery date). | Drug | Temsirolimus (pre-surgery) |
Primary outcome
The rate of change in response of primary tumor and metastases (if applicable)in participants.
Time frame: Baseline, Weeks 1-12, follow up every 3 months for years 1 and 2, and every 6 months for following three years (5 years in total).
Rate of Change in response of primary tumor and metastases (if applicable) to neo-adjuvant Temsirolimus in terms of tumour size and appearance (RECIST imaging response criteria) as determined by CT or MRI.
2 secondary outcomes
Average time for disease progression.
Time frame: At every visit; baseline, weekly visits, and follow-up.
Quality of life data
Time frame: Baseline, weekly visits, follow-up
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 27 Jul 2016.
Related trials for Renal Cell Carcinoma
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.
Anil Kapoor, MD principal investigator
McMaster Institute of Urology - St. Joseph's Healthcare Hamilton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temsirolimus (pre surgery) in people with Renal Cell Carcinoma, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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 8 inclusion and 14 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 27 Jul 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 Canada. 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.
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?
The rate of change in response of primary tumor and metastases (if applicable)in participants. (time frame: Baseline, Weeks 1-12, follow up every 3 months for years 1 and 2, and every 6 months for following three years (5 years in total).). 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 27 Jul 2016.