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Tyrosine Kinase Inhibitor
Immunotherapy for Advanced Rare Cancers
Phase 2
Waitlist Available
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new immunotherapy treatment for cancer that has not responded to other treatments.
Who is the study for?
This trial is for patients with advanced rare tumors who have measurable disease, are over 16 years old (or over 5 for a specific cohort), and have an ECOG performance status of 0-2. They should not have received certain prior treatments and must meet lab requirements. Exclusions include cardiovascular issues, recent heart or brain events, inability to absorb oral meds, known drug sensitivities, other cancer histories or concurrent cancer treatments.
What is being tested?
The study tests Sunitinib and Temsirolimus in patients with no cure-available cancers to see if these drugs can shrink the tumors. It's a Phase II trial which means it's checking the effectiveness of these drugs on this particular type of tumor after initial safety has been established.
What are the potential side effects?
Potential side effects may include high blood pressure; bleeding or clotting problems; weak immune system leading to infections; liver issues; fatigue; mouth sores; nausea and vomiting. Specific to Sunitinib: heart problems, thyroid changes. For Temsirolimus: rash, elevated blood sugar levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Response
Secondary study objectives
Efficacy Outcomes
Safety Monitoring
Translational Research
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: SunitinibActive Control1 Intervention
Group II: TemsirolimusActive Control1 Intervention
Find a Location
Who is running the clinical trial?
PfizerIndustry Sponsor
4,658 Previous Clinical Trials
17,877,150 Total Patients Enrolled
4 Trials studying Tumors
1,873 Patients Enrolled for Tumors
Canadian Cancer Trials GroupLead Sponsor
132 Previous Clinical Trials
69,730 Total Patients Enrolled
Hal HirteStudy ChairJuravinski Cancer Centre at Hamilton Health Sciences, Hamilton, ON Canada
1 Previous Clinical Trials
59 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at least 16 years old, or at least 5 for a specific study group.You are expected to live for at least 12 more weeks.I meet the requirements for past treatments (chemo, radiation, surgery).My cancer is a rare type confirmed by lab tests.My cancer can be measured by a doctor's exam or imaging.I can take care of myself and perform daily activities.I can start the treatment within 5 days of signing up.I have had cancer before, but it was a specific type that is allowed.You are pregnant or breastfeeding.You are allergic to the study drug or any of its ingredients.I have brain metastases that are causing symptoms.I am not currently receiving any other cancer treatments or experimental drugs.I have been treated with specific inhibitors for my condition.I can attend all treatment, check-up, and follow-up appointments.I do not have any serious illness that prevents following the study's protocol.I have tissue from my original tumor available.My condition cannot be treated with surgery and has no standard treatments to extend life.
Research Study Groups:
This trial has the following groups:- Group 1: Sunitinib
- Group 2: Temsirolimus
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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