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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-01390 | Other Identifier | NCI/CTRP |
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RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Recombinant interferon alfa-2b may interfere with the growth of cancer cells and slow the growth of kidney cancer. Giving celecoxib together with recombinant interferon alpha-2b may kill more tumor cells and be an effective treatment for metastatic kidney cancer.
PURPOSE: This phase II trial is studying how well giving celecoxib together with recombinant interferon alfa-2b works in treating patients with metastatic kidney cancer who have undergone surgery.
PRIMARY OBJECTIVES:
I. To estimate the objective response rate of interferon alpha plus celecoxib in metastatic RCC patients with 3+ COX-2 tumor immunostaining.
SECONDARY OBJECTIVES:
I. To compare cellular immune parameters in metastatic RCC patients with 3+ COX-2 tumor immunostaining to patients with < 1+ tumor immunostaining.
II. To evaluate the effect of celecoxib and interferon alpha therapy on cellular immune parameters in metastatic RCC patients with 3+ COX-2 tumor immunostaining.
OUTLINE:
Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| celecoxib | Drug | Given orally |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate Assessed by RECIST Criteria. | The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started, including baseline). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Objective response will be assessed by RECIST criteria. | at week 4 of cycle 2 and every other cycle thereafter |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival measured in months and summarized using the Kaplan-Meier method. | death |
| Duration of Response | The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, including baseline). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that recurrent disease is objectively documented. |
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Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Brian Rini | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
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Patients accrued from medical clinic from June 2006 through July 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Celecoxib and Recombinant Interferon Alpha-2b | Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| recombinant interferon alfa-2b | Biological | Given subcutaneously |
|
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| polymerase chain reaction | Other | Correlative studies |
|
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| laboratory biomarker analysis | Other | Correlative studies |
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| reverse transcriptase-polymerase chain reaction | Other | Correlative studies |
|
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| immunologic technique | Other | Correlative studies |
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| immunohistochemistry staining method | Other | Correlative studies |
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| flow cytometry | Other | Correlative studies |
|
| end of study |
| Progression-free Survival | Progression-free survival measured in months and summarized using the Kaplan-Meier method. Time to objective progression will be measured from the start of treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including baseline. | to progression |
| Number of Patients With Statistically Significant Change in Cellular Immune Parameters From Baseline to 2 Months | To evaluate the effect of celecoxib and interferon alpha therapy on cellular immune parameters. Absolute change following two cycles of therapy. | at two months from start of treatment |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Celecoxib and Recombinant Interferon Alpha-2b | Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | Objective Response Rate Assessed by RECIST Criteria. | The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started, including baseline). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Objective response will be assessed by RECIST criteria. | Posted | Number | participants | at week 4 of cycle 2 and every other cycle thereafter |
|
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| |||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival measured in months and summarized using the Kaplan-Meier method. | Posted | Median | 95% Confidence Interval | months | death |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, including baseline). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that recurrent disease is objectively documented. | Patients who achieved at least a partial response | Posted | Median | Full Range | months | end of study |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Progression-free survival measured in months and summarized using the Kaplan-Meier method. Time to objective progression will be measured from the start of treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including baseline. | Posted | Median | 95% Confidence Interval | months | to progression |
|
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| Secondary | Number of Patients With Statistically Significant Change in Cellular Immune Parameters From Baseline to 2 Months | To evaluate the effect of celecoxib and interferon alpha therapy on cellular immune parameters. Absolute change following two cycles of therapy. | Patients that received treatment | Posted | Number | participants | at two months from start of treatment |
|
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From time patients went on study to off study, a period of 4 years
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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 | Celecoxib and Recombinant Interferon Alpha-2b | Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. | 2 | 17 | 17 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizures | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/embolism | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alkaline Phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constitutional Symptoms-other | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dermatology/Skin-other | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Patients without colostomy |
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| Dizziness/lightheadedness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Extrapyramidal/involuntary movement/restlessness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment | lethargy, malaise, asthenia |
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| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
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| Leukocytes | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Metabolic/Laboratory-Other | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood alteration | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment | depression |
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| Mood alteration | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment | anxiety, agitation |
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| Mouth dryness | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | not due to neuropathy |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neurology-Other | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy-sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutophils/Granulocytes | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Prutitus | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rigors,Chills | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| SGOT (AST) | Investigations | CTCAE (3.0) | Systematic Assessment | serum glutamic oxaloacetic transaminase |
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| SGPT (ALT) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Stomatitis/pharyngitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | oral/pharyngeal mucositis |
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| Taste Disturbance (dysgeusia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weight Loss | Investigations | CTCAE (3.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Rini | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | 216-444-9567 | rinib2@ccf.org |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| D007438 | Introns |
| D000077190 | Interferon alpha-2 |
| D016133 | Polymerase Chain Reaction |
| D020133 | Reverse Transcriptase Polymerase Chain Reaction |
| D007158 | Immunologic Techniques |
| D007150 | Immunohistochemistry |
| D005434 | Flow Cytometry |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D021901 | DNA, Intergenic |
| D040481 | Genome Components |
| D016678 | Genome |
| D040342 | Genetic Structures |
| D055614 | Genetic Phenomena |
| D040461 | Gene Components |
| D005796 | Genes |
| D016898 | Interferon-alpha |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D002469 | Cell Separation |
| D003592 | Cytophotometry |
| D005470 | Fluorometry |
| D008163 | Luminescent Measurements |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
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| Title | Measurements |
|---|---|
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| No Response |
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| Title | Denominators | Categories |
|---|
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