Celecoxib and Recombinant Interferon Alfa-2b in Metastatic Kidney Cancer Who Have Undergone Surgery

NCT01158534 | Completed Phase 2 Results DMC

• 2 other identifiers: CASE8805NCI-2010-01390
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Cell Cancer; Stage IV Renal Cell Cancer

Keywords

recurrent renal cell cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Overall Survival

  death

• Duration of Response

  end of study

• Progression-free Survival

  to progression

• Number of Patients With Statistically Significant Change in Cellular Immune Parameters From Baseline to 2 Months

  at two months from start of treatment

Study Arms (1)

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.

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

Interventions

celecoxib DRUG

Given orally

Also known as: Celebrex, SC-58635, YM 177

Arm I

recombinant interferon alfa-2b BIOLOGICAL

Given subcutaneously

Also known as: Alfatronol, Glucoferon, Heberon Alfa, IFN alpha-2B, interferon alfa-2B, Intron A

Arm I

polymerase chain reaction OTHER

Correlative studies

Also known as: PCR

Arm I

laboratory biomarker analysis OTHER

Correlative studies

Arm I

reverse transcriptase-polymerase chain reaction OTHER

Correlative studies

Also known as: RT-PCR

Arm I

immunologic technique OTHER

Correlative studies

Also known as: immunological laboratory methods, laboratory methods, immunological

Arm I

immunohistochemistry staining method OTHER

Correlative studies

Also known as: immunohistochemistry

Arm I

flow cytometry OTHER

Correlative studies

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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%

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Celecoxib; Introns; Interferon alpha-2; Polymerase Chain Reaction; Reverse Transcriptase Polymerase Chain Reaction; Immunologic Techniques; Immunohistochemistry; Flow Cytometry

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; DNA, Intergenic; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Gene Components; Genes; Interferon-alpha; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Cell Separation; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical

Results Point of Contact

• Title: Dr. Brian Rini
• Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

rinib2@ccf.org

216-444-9567

Study Officials

• Brian Rini

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2010
• First Posted: July 8, 2010
• Study Start: March 1, 2006
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 7, 2012
• Results First Posted: July 12, 2012

Record last verified: 2012-08

Locations

US (1)