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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01238 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| Celgene | INDUSTRY |
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The goal of this clinical research study is to learn if the combination of ipilimumab and ABI-007 (abraxane) can help to control metastatic melanoma. The safety of this drug combination will also be studied.
Ipilimumab is designed to increase the immune system's ability to fight cancer.
Abraxane is designed to stop cancer cells from making new DNA (the genetic material of cells). This may stop the cancer cells from dividing into new cells.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive ABI-007 by vein over about 30 minutes on Days 1, 8, and 15 of each 28-day cycle. During the first 3 months that you receive abraxane, you will also receive ipilimumab. You will receive ipilimumab by vein over about 90 minutes. You will receive it 4 times, each time about 3 weeks apart.
You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.
Study Tests:
Every week, blood (about 1 teaspoon) will be drawn for routine tests.
Before each cycle of abraxane:
Every 8 weeks (+/- 7 days), you will have a chest x-ray and CT scans or MRI scans performed to check the status of the disease.
Length of Study:
You may receive ipilimumab for up to 3 months. You may continue taking abraxane for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drugs if the disease gets worse or intolerable side effects occur.
If you stop receiving the study drugs for any reason, you will have an End-of-Treatment Visit.
End-of-Treatment Visit:
Within 14 days after you stop study treatment, you will come into the clinic for the End-of-Treatment Visit. At this visit, the following tests will be performed:
Every 2 months for 6 months, then every 3 months for up to 2 years, you will also be contacted by telephone or during a routine clinic visit to see how you are doing. If you are called, each call should last about 5 minutes.
This is an investigational study. Ipilimumab is FDA approved and commercially available for the treatment of metastatic melanoma. abraxane is FDA approved and commercially available for the treatment of metastatic breast cancer. It is investigational to use abraxane, either alone or in combination with ipilimumab, for the treatment of metastatic melanoma.
Up to 64 patients will take part in this study. All will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABI-007 + Ipilimumab | Experimental | Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. Ipilimumab 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses. Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABI-007 | Drug | Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. The cycle length for ABI-007 is 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Overall Survival Response to Abraxane Plus Ipilimumab Therapy | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.1) was used. Complete Response (CR)= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, no new lesions; Partial Response (PR)= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 50 months |
| Median Progression Free Survival | Progression-free survival (PFS) is the time from random assignment in a clinical trial to disease progression or death from any cause. | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 50 months |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adi Diab, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas 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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21 participants signed the consent, 2 participants did not received treatment (1) withdrew prior treatment and (1) not eligible due to angiosarcoma (no melanoma).
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| ID | Title | Description |
|---|---|---|
| FG000 | ABI-007 + Ipilimumab | Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. Ipilimumab 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses. Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes. ABI-007: Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. The cycle length for ABI-007 is 28 days. Ipilimumab: 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses. Phone Call: Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ABI-007 + Ipilimumab | Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. Ipilimumab 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses. Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes. ABI-007: Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. The cycle length for ABI-007 is 28 days. Ipilimumab: 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses. Phone Call: Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Median Overall Survival Response to Abraxane Plus Ipilimumab Therapy | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.1) was used. Complete Response (CR)= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm, no new lesions; Partial Response (PR)= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | Posted | Median | Full Range | months | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 50 months |
|
up to 50 months
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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 | ABI-007 + Ipilimumab | Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. Ipilimumab 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound Infection | Investigations | CTCAE (4.3) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.3) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adi Diab, MD-Associate Professor, Melanoma Medical Oncology | UT MD Anderson Cancer Center | (713) 745-7336 | adiab@mdanderson.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 26, 2018 | Sep 13, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| C520255 | 130-nm albumin-bound paclitaxel |
| D017239 | Paclitaxel |
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
| Ipilimumab | Drug | 3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses. |
|
|
| Phone Call | Behavioral | Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes. |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Median Progression Free Survival | Progression-free survival (PFS) is the time from random assignment in a clinical trial to disease progression or death from any cause. | Posted | Median | 95% Confidence Interval | months | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 50 months |
|
|
|
| 0 |
| 18 |
| 2 |
| 18 |
| 18 |
| 18 |
| Hypophysitis | Endocrine disorders | CTCAE (4.3) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | CTCAE (4.3) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.3) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.3) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.3) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.3) | Systematic Assessment |
|
| Lung Infection | Respiratory, thoracic and mediastinal disorders | CTCAE (4.3) | Systematic Assessment |
|
| Hypotension | Cardiac disorders | CTCAE (4.3) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.3) | Systematic Assessment |
|
| Macular Cystoid | Eye disorders | CTCAE (4.3) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.3) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.3) | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | CTCAE (4.3) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.3) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.3) | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | CTCAE (4.3) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.3) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.3) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.3) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.3) | Systematic Assessment |
|
| Transaminitis | Investigations | CTCAE (4.3) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.3) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.3) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.3) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.3) | Systematic Assessment |
|
| Hypertension | Cardiac disorders | CTCAE (4.3) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (4.3) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.3) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | CTCAE (4.3) | Systematic Assessment |
|
| Mucositis | Gastrointestinal disorders | CTCAE (4.3) | Systematic Assessment |
|
| Elevated Bilirubin | Investigations | CTCAE (4.3) | Systematic Assessment |
|
| Elevated Creatinine | Investigations | CTCAE (4.3) | Systematic Assessment |
|
| Hypophysitis | Endocrine disorders | CTCAE (4.3) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (4.3) | Systematic Assessment |
|
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |