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Alkylating Agent
Dasatinib + Temsirolimus + Cyclophosphamide for Cancer
Phase 1
Waitlist Available
Led By Wafik T Zaky
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 days post-treatment
Awards & highlights
All Individual Drugs Already Approved
Approved for 20 Other Conditions
No Placebo-Only Group
Summary
This trial is studying dasatinib, temsirolimus, and cyclophosphamide to treat patients with solid tumors.
Who is the study for?
This trial is for patients under 21 with advanced solid tumors, including brain tumors, that have spread or not responded to treatment. They must have proper liver and kidney function, stable neurological status if they have brain tumors, and a life expectancy of at least 12 weeks. Patients should not be pregnant or breastfeeding, HIV positive, or have had certain recent health issues like heart disease.
What is being tested?
The trial tests the combination of dasatinib and temsirolimus with cyclophosphamide in patients with recurrent or resistant solid tumors. It aims to find the safest doses and observe how these drugs might stop tumor growth by inhibiting specific enzymes needed for cell division.
What are the potential side effects?
Potential side effects include reactions related to the immune system's response to the drugs, possible damage to organs due to inflammation caused by drug interactions within cells, blood disorders from chemotherapy agents affecting bone marrow function, fatigue from overall body stress due to treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 28 days post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 days post-treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events (AEs) graded according to NCI CTCAE version 4.0
Secondary study objectives
Best response (complete response [CR], partial response [PR], stable disease [SD], and progressive disease [PD]) using the Response Evaluation Criteria in Solid Tumors from the NCI for assessment of radiographic response
Levels of biological markers measured in tissue, blood, or plasma
Side effects data
From 2022 Phase 2 trial • 54 Patients • NCT0302304626%
Febrile neutropenia
17%
Sepsis
9%
Mucositis oral
4%
Upper gastrointestinal hemorrhage
4%
Hypotension
4%
Hypertension
4%
Intracranial hemorrhage
4%
Enterocolitis
2%
Small intestinal obstruction
2%
Lower gastrointestinal hemorrhage
2%
Fungemia
2%
Peripheral motor neuropathy
2%
Typhlitis
2%
Oropharyngeal pain
2%
Multi-organ failure
2%
Abdominal pain
2%
Hypoxia
2%
Kidney infection
2%
Edema limbs
2%
Sinus bradycardia
2%
Gastric hemorrhage
2%
Myocardial infarction
2%
Diarrhea
2%
Fibrinogen decreased
2%
Aspiration
2%
Atrial fibrillation
2%
Delirium
2%
Endophthalmitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy)
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (dasatinib, cyclophosphamide, temsirolimus)Experimental Treatment4 Interventions
Patients receive dasatinib PO BID on days 1-21, cyclophosphamide PO QD on days 1-21, and temsirolimus IV over 30-60 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing stable disease or better may continue treatment with the approval of the Study Chair.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dasatinib
FDA approved
Cyclophosphamide
FDA approved
Sirolimus
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,794 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,938 Previous Clinical Trials
41,023,165 Total Patients Enrolled
Wafik T ZakyPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
18 Total Patients Enrolled