Celecoxib and Recombinant Interferon Alfa-2b in Metastatic Kidney Cancer Who Have Undergone Surgery
This study has been completed.
Sponsor:
Case Comprehensive Cancer Center
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01158534
First received: July 6, 2010
Last updated: August 2, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Cell Cancer Stage IV Renal Cell Cancer |
Drug: celecoxib Biological: recombinant interferon alfa-2b Other: polymerase chain reaction Other: laboratory biomarker analysis Other: reverse transcriptase-polymerase chain reaction Other: immunologic technique Other: immunohistochemistry staining method Other: flow cytometry |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Celecoxib Plus Interferon Alpha in Metastatic Renal Cell Carcinoma Patients With 3+ COX-2 Tumor Immunostaining |
Resource links provided by NLM:
Further study details as provided by Case Comprehensive Cancer Center:
Primary Outcome Measures:
- Objective Response Rate Assessed by RECIST Criteria. [ Time Frame: at week 4 of cycle 2 and every other cycle thereafter ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Overall Survival [ Time Frame: death ] [ Designated as safety issue: No ]Overall survival measured in months and summarized using the Kaplan-Meier method.
- Duration of Response [ Time Frame: end of study ] [ Designated as safety issue: No ]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.
- Progression-free Survival [ Time Frame: to progression ] [ Designated as safety issue: No ]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.
- Number of Patients With Statistically Significant Change in Cellular Immune Parameters From Baseline to 2 Months [ Time Frame: at two months from start of treatment ] [ Designated as safety issue: No ]To evaluate the effect of celecoxib and interferon alpha therapy on cellular immune parameters. Absolute change following two cycles of therapy.
| Enrollment: | 17 |
| Study Start Date: | March 2006 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
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.
|
Drug: celecoxib
Given orally
Other Names:
Biological: recombinant interferon alfa-2b
Given subcutaneously
Other Names:
Other: polymerase chain reaction
Correlative studies
Other Name: PCR
Other: laboratory biomarker analysis
Correlative studies
Other: reverse transcriptase-polymerase chain reaction
Correlative studies
Other Name: RT-PCR
Other: immunologic technique
Correlative studies
Other Names:
Other: immunohistochemistry staining method
Correlative studies
Other Name: immunohistochemistry
Other: flow cytometry
Correlative studies
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Criteria
- Patients must have histologically-confirmed metastatic renal cell carcinoma
- Patients must have 3+ (on a scale of 0 to 3+) COX-2 staining in >= 10% of the RCC tumor cells from baseline tumor tissue
- Patients must not have received any prior cytokine therapy for renal cell carcinoma
- Patients may have received any number of prior non-cytokine systemic therapies for metastatic RCC
- Patients must have undergone nephrectomy (radical or partial)
- All patients must be at least 2 weeks from prior systemic therapy, radiation or major surgery
- Patients must have measurable disease per RECIST criteria
- ECOG performance status 0 or 1
- Leukocytes >= 3,000/mL
- Absolute neutrophil count >= 1,500/mL
- Platelets >= 75,000/mL
- Total bilirubin =< 1.5x institutional upper limit
- AST(SGOT)/ALT(SGPT) =< 2.5x institutional upper limit
- Creatinine =< 2.0x institutional upper limit
- No significant cardiovascular disease including congestive heart failure (New York Heart Association Class III or IV), active angina pectoris requiring nitrate therapy, uncontrolled dysrhythmias or recent cardiovascular event (defined as any of the following within the previous 6 months: TIA/CVA, MI, vascular surgery)
- Ability to understand and the willingness to sign a written informed consent document
- Patients with any untreated CNS metastases are excluded from this clinical trial; patients who have undergone surgery and/or radiation for CNS metastases are eligible for enrollment if they do not have CNS metastases that have not been treated, are at least 2 weeks from treatment of CNS metastases without evidence of CNS disease progression (stable CT scan or MRI) and are off steroids; all patients must undergo an MRI or infused CT scan of the brain prior to enrollment
- Patients may not be concurrently receiving any other investigational agents
- Pregnant women; women of childbearing potential must have a negative pregnancy test prior to enrollment and use adequate contraception while on study and for one month thereafter
- Concurrent systemic steroid therapy is prohibited (inhaled or topical steroids as well as physiologic replacement doses of steroids are permitted)
- Patients with a history of a severe allergic reaction (defined as a grade 4 rash, a reaction requiring steroids or epinephrine or any degree of airway compromise) to sulfonamide or sulfonamide derivatives drugs are excluded; this includes, but is not limited to, sulfonamide antibiotics such as sulfadiazine, sulfamethoxazole, sulfisoxazole and sulfacetamide and sulfonamide derivatives such as celecoxib, valdecoxib, diuretics (HCTZ, furosemide), sulfonylureas, dorzolamide and sumatriptan
- Karnofsky >= 70%
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01158534
Locations
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
| Principal Investigator: | Brian Rini | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center |
More Information
No publications provided
| Responsible Party: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01158534 History of Changes |
| Other Study ID Numbers: | CASE8805, NCI-2010-01390 |
| Study First Received: | July 6, 2010 |
| Results First Received: | April 26, 2012 |
| Last Updated: | August 2, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Case Comprehensive Cancer Center:
|
recurrent renal cell cancer |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Interferon-alpha Interferon Alfa-2a Interferon Alfa-2b |
Interferons Reaferon Celecoxib Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on May 19, 2013