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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00516 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 0220080282 | Other Identifier | IRB number | |
| P30CA072720 | U.S. NIH Grant/Contract | View source | |
| 020803 | Other Identifier | Rutgers Cancer Institute of New Jersey |
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| Name | Class |
|---|---|
| Rutgers Cancer Institute of New Jersey | OTHER |
| National Cancer Institute (NCI) | NIH |
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This randomized phase II trial studies how well choline magnesium trisalicylate with idarubicin and cytarabine works in treating patients with acute myeloid leukemia. Drugs used in chemotherapy, such as choline magnesium trisalicylate, idarubicin, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet know whether choline magnesium trisalicylate and combination chemotherapy is more effective than combination chemotherapy alone in treating patients with acute myeloid leukemia.
PRIMARY OBJECTIVES:
I. To determine temporal changes in leukemic cell nuclear factor of kappa light chain enhancer of B-cells 1 (NF-kB) activity when salicylate (choline magnesium trisalicylate) is administered to patients with acute myeloid leukemia (AML) during induction chemotherapy.
II. To determine toxicities associated with administration of salicylate in the setting of induction chemotherapy.
III. To determine if salicylate alters the expression of NF-kB-regulated genes in AML cells.
IV. To determine if NF-kB modulation by salicylate alters AML chemotherapy drug efflux.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive choline magnesium trisalicylate orally (PO) every 8 hours on days 0-7, idarubicin intravenously (IV) on days 1-3, and cytarabine IV continuously on days 1-7.
ARM II: Patients receive idarubicin IV on days 1-3 and cytarabine IV continuously on days 1-7.
In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (choline magnesium trisalicylate and chemotherapy) | Experimental | Patients receive choline magnesium trisalicylate PO every 8 hours on days 0-7, idarubicin IV on days 1-3, and cytarabine IV continuously on days 1-7. |
|
| Arm II (chemotherapy) | Active Comparator | Patients receive idarubicin IV on days 1- 3 and cytarabine IV continuously on days 1-7. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| choline magnesium trisalicylate | Drug | Given PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inhibition of NF-kB Target Transcripts and/or Inhibition of Drug Efflux in at Least 50% of Patients | The clinical trial will be based on a sequential monitoring so that we will have a 90% confidence that choline magnesium trisalicylate (CMT) based modulation of NF-kB transcriptional targets and/or drug efflux occurs in at least 50% of patients. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger Strair | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
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Subjects were recruited through the Rutgers Cancer Institute of New Jersey. The study was open to accrual on 10/31/2008 and completed on 01/06/2015. All participants visits were completed and the study was closed by the Principal Investigator on 04/26/2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Choline Magnesium Trisalicylate and Chemotherapy) | Patients receive choline magnesium trisalicylate PO every 8 hours on days 0-7, idarubicin IV on days 1-3, and cytarabine IV continuously on days 1-7. choline magnesium trisalicylate: Given PO idarubicin: Given IV cytarabine: Given IV laboratory biomarker analysis: Correlative studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| idarubicin | Drug | Given IV |
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| cytarabine | Drug | Given IV |
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| laboratory biomarker analysis | Other | Correlative studies |
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| FG001 |
| Arm II (Chemotherapy) |
Patients receive idarubicin IV on days 1- 3 and cytarabine IV continuously on days 1-7. idarubicin: Given IV cytarabine: Given IV laboratory biomarker analysis: Correlative studies |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Choline Magnesium Trisalicylate and Chemotherapy) | Patients receive choline magnesium trisalicylate PO every 8 hours on days 0-7, idarubicin IV on days 1-3, and cytarabine IV continuously on days 1-7. choline magnesium trisalicylate: Given PO idarubicin: Given IV cytarabine: Given IV laboratory biomarker analysis: Correlative studies |
| BG001 | Arm II (Chemotherapy) | Patients receive idarubicin IV on days 1- 3 and cytarabine IV continuously on days 1-7. idarubicin: Given IV cytarabine: Given IV laboratory biomarker analysis: Correlative studies |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Inhibition of NF-kB Target Transcripts and/or Inhibition of Drug Efflux in at Least 50% of Patients | The clinical trial will be based on a sequential monitoring so that we will have a 90% confidence that choline magnesium trisalicylate (CMT) based modulation of NF-kB transcriptional targets and/or drug efflux occurs in at least 50% of patients. | Posted | Count of Participants | Participants | 24 hours |
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Adverse events were collected over a period of approximately 1.5 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 | Arm I (Choline Magnesium Trisalicylate and Chemotherapy) | Patients receive choline magnesium trisalicylate PO every 8 hours on days 0-7, idarubicin IV on days 1-3, and cytarabine IV continuously on days 1-7. choline magnesium trisalicylate: Given PO idarubicin: Given IV cytarabine: Given IV laboratory biomarker analysis: Correlative studies | 0 | 13 | 1 | 13 | 7 | 13 |
| EG001 | Arm II (Chemotherapy) | Patients receive idarubicin IV on days 1- 3 and cytarabine IV continuously on days 1-7. idarubicin: Given IV cytarabine: Given IV laboratory biomarker analysis: Correlative studies | 0 | 14 | 0 | 14 | 10 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alkalosis (metabolic or respiratory) | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Dermal change lymphedema, phlebolymphedema | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Colitis | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | Systematic Assessment |
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| Low Platelets | Blood and lymphatic system disorders | Systematic Assessment |
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| Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infe | Infections and infestations | Systematic Assessment |
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| Low Hemoglobin | Blood and lymphatic system disorders | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia) | Infections and infestations | Systematic Assessment |
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| Glucose, serum-high (hyperglycemia) | General disorders | Systematic Assessment |
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| Potassium, serum-low (hypokalemia) | General disorders | Systematic Assessment |
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| Calcium, serum-low (hypocalcemia) | General disorders | Systematic Assessment |
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| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Mucositis/stomatitis (clinical exam) - Oral cavity | Gastrointestinal disorders | Systematic Assessment |
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| Heartburn/dyspepsia | Gastrointestinal disorders | Systematic Assessment |
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| Enteritis (inflammation of the small bowel) | Gastrointestinal disorders | Systematic Assessment |
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| Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation) | Gastrointestinal disorders | Systematic Assessment |
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| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e | Infections and infestations | Systematic Assessment |
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| Cystitis | Renal and urinary disorders | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pain - Abdomen NOS | General disorders | Systematic Assessment |
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| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | Systematic Assessment |
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| Pain - Head/headache | General disorders | Systematic Assessment |
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| Pain - Sore Throat | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roger Strair, MD, PhD | Rutgers Cancer Institute of New Jersey | 732-235-7298 | strairrk@cinj.rutgers.edu |
| ID | Term |
|---|---|
| D007947 | Leukemia, Megakaryoblastic, Acute |
| D007948 | Leukemia, Monocytic, Acute |
| D015470 | Leukemia, Myeloid, Acute |
| D000013 | Congenital Abnormalities |
| D015479 | Leukemia, Myelomonocytic, Acute |
| D004915 | Leukemia, Erythroblastic, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
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| ID | Term |
|---|---|
| C017959 | choline magnesium trisalicylate |
| D015255 | Idarubicin |
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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