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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01265 | Registry Identifier | NCI CTRP |
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Slow Accrual
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The goal of this clinical research study is to learn if temsirolimus can help to control advanced cancer in patients who also have a PI3K mutation and/or PTEN loss. The safety of this drug will also be tested.
The Study Drug:
Temsirolimus is designed to block the growth of cancer cells, which may cause the cancer cells to die.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive temsirolimus through a needle in your vein on Days 1, 8, 15, and 22 of each 4-week study cycle. On Day 1 of Cycle 1, the study drug will be given over 60 minutes. If you tolerate the study drug well on Day 1 of Cycle 1, it will be given over 30 minutes at all other scheduled administration dates as long as you still tolerate it well. If the dose is not well tolerated, the dose will be reduced for future study visits.
You will receive Benadryl (diphenhydramine) or a similar drug by vein to help prevent side effects about 30 minutes before you receive the study drug.
Study Visits:
One (1) time each week (on each day that the study drug is being given), the following tests and procedures will be performed:
At 8 hours (+/- 3 hours) after the dose At 24 hours (+/- 3 hours) after the dose At 72 hours (+/- 24 hours) after the dose
Every 2 weeks, blood (about 2 teaspoons) will be drawn for routine tests.
Every 4 weeks, you will have a physical exam; women who are able to become pregnant will also have a blood (about 1 teaspoon) pregnancy test.
Every 8 weeks, you will have a CT scan, MRI scan, and/or PET/CT scan to check the status of the disease.
Length of Study:
You will be on study for as long as you are benefiting or the disease is stable. You will be taken off study if the disease gets worse, you have intolerable side effects, or the study doctor thinks it is in your best interest.
End-of-Study Visit:
After you have finished taking the study drug, the following tests and procedures will be performed:
This is an investigational study. Temsirolimus is FDA-approved and commercially available for the treatment of advanced renal cancer. Its use in other types of cancer is investigational.
Up to 65 patients will take part in this study. All will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Temsirolimus | Experimental | Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temsirolimus | Drug | 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response | For solid tumors, initial responses defined by Response Evaluation Criteria in Solid (RECIST) criteria in the evaluable lesion(s) per Complete Response (CR): Disappearance of all target lesions; confirmed at 4 weeks; Partial Response (PR): At least 30% decrease; confirmed at 4 weeks; Stable Disease (SD): Neither PR nor PD criteria met; Progressive Disease (PD): 20% increase; no CR, PR or SD documented before increased disease, or new lesion(s). | Baseline to Disease Progression (restaged at 8 weeks and at 4 months) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Karp, MD | UT MD Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Recruitment Period: April 6, 2009 to March 28, 2013. All recruitment done at The University of Texas MD Anderson Cancer Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Temsirolimus | Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Temsirolimus | Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tumor Response | For solid tumors, initial responses defined by Response Evaluation Criteria in Solid (RECIST) criteria in the evaluable lesion(s) per Complete Response (CR): Disappearance of all target lesions; confirmed at 4 weeks; Partial Response (PR): At least 30% decrease; confirmed at 4 weeks; Stable Disease (SD): Neither PR nor PD criteria met; Progressive Disease (PD): 20% increase; no CR, PR or SD documented before increased disease, or new lesion(s). | Of the 44 participants enrolled, only 30 were evaluable for response. | Posted | Number | participants | Baseline to Disease Progression (restaged at 8 weeks and at 4 months) |
|
Adverse event collection through 2 cycles (about 8 weeks) of treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Temsirolimus | Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Symptomatic Hydrocephalous | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Karp, MD / Professor, Investigational Cancer Therapeutics | University of Texas (UT) MD Anderson Cancer Center | CR_Study_Registration@mdanderson.org |
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| ID | Term |
|---|---|
| C401859 | temsirolimus |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 6 |
| 44 |
| 19 |
| 44 |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weakness | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Headaches | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Syncopal Episode | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | with gram-negative rods |
|
| Cachexia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ventilatory Respiratory Failure | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Acute Myocardial Infarction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tongue Swelling | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Acute Renal Insufficiency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Increased Swelling of the Face | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Partial Small Bowel Obstruction | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Aphasia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Right-Sided Upper Extremity Weakness | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Acute Renal Failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Increased Ascites | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Syncopal Episode | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Unbalanced | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ulceration | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Brain Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Epitaxis | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
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