PEG-Interferon Alfa-2b and Sorafenib in Treating Patients With Unresectable or Metastatic Kidney Cancer

NCT00589550 | Terminated Phase 1 Results DMC

• 1 other identifier: OSU-06113
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stop the growth of kidney cancer by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b together with sorafenib may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of PEG-interferon alfa-2b and sorafenib in treating patients with unresectable or metastatic kidney cancer.

Conditions

Kidney Cancer

Keywords

clear cell renal cell carcinoma; stage III renal cell cancer; stage IV renal cell cancer

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose of PEG-interferon Alfa-2b and Sorafenib Tosylate

  up to 2 months

• Characterize the Toxicity of Peginterferon Alfa-2b and Sorafenib in Patients With Metastatic or Unresectable Clear Cell Renal Cell Carcinoma.

  up to 2 months

Secondary Outcomes (5)

• Progression-free Survival of Patients Receiving Peginterferon Alfa-2b and Sorafenib.

  up to 1 year

• Response Rate of Patients Receiving Peginterferon Alfa-2b and Sorafenib.

  up to 1 year

• Overall Survival

  up to 1 year

• Activation of Interferon-induced Transcription Factors in Immune Cell Subsets by Flow Cytometry and Correlation of This Information With Clinical Outcome

  up to 1 year

• Circulating Levels of IFN-γ and IL-5 for Determination of Th1/Th2 Status and CD4+, CD25+, and FoxP3 Cell Number (T Regs) in Peripheral Blood

  Up to 1 year

Study Arms (1)

Peginterferon alfa-2b

EXPERIMENTAL

Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.

Biological: PEG-interferon alfa-2b; Drug: Sorafenib; Genetic: gene expression analysis; Genetic: polymerase chain reaction; Genetic: reverse transcriptase-polymerase chain reaction; Other: flow cytometry; Other: immunoenzyme technique; Other: laboratory biomarker analysis

Interventions

PEG-interferon alfa-2b BIOLOGICAL

administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.

Also known as: peginterferon alfa-2b

Peginterferon alfa-2b

Sorafenib DRUG

Also known as: Nexavar, BAY 54-9085 is the tosylate salt of BAY 43-9006

Peginterferon alfa-2b

gene expression analysis GENETIC

Peginterferon alfa-2b

polymerase chain reaction GENETIC

Peginterferon alfa-2b

reverse transcriptase-polymerase chain reaction GENETIC

Peginterferon alfa-2b

flow cytometry OTHER

Peginterferon alfa-2b

immunoenzyme technique OTHER

Peginterferon alfa-2b

laboratory biomarker analysis OTHER

Peginterferon alfa-2b

Eligibility Criteria

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

You may qualify if:

• Must have histologically or cytologically confirmed clear cell renal cell carcinoma (RCC)
• Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension and is ≥ 1.0 cm by spiral CT scan
• No prior treatment except
• PATIENT CHARACTERISTICS:
• ECOG performance status 0-1
• Life expectancy \> 6 months
• Good/intermediate Motzer prognostic status
• ANC ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10.0 g/dL
• Total bilirubin ≤ 2.0 mg/dL
• AST and ALT \< 2.5 times normal
• Creatinine ≤ 1.8 mg/dL OR creatinine clearance \> 50 mL/min
• Calcium \< 12 mg/dL (when corrected for serum albumin)
• INR \< 1.5 times upper limit of normal

Sponsors & Collaborators

• Thomas Olencki: lead
• Schering-Plough: collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

peginterferon alfa-2b; Sorafenib; Gene Expression Profiling; Polymerase Chain Reaction; Reverse Transcriptase Polymerase Chain Reaction; Flow Cytometry; Immunoenzyme Techniques

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Genetic Techniques; Investigative Techniques; Nucleic Acid Amplification Techniques; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Immunoassay; Immunologic Techniques; Immunohistochemistry; Molecular Probe Techniques

Limitations and Caveats

Trial was terminated due to low patient accrual

Results Point of Contact

• Title: Thomas Olencki, DO
• Organization: The Ohio State University Comprehensive Cancer Center

Thomas.Olencki@osumc.edu

614-293-2886

Study Officials

• Thomas E. Olencki, DO

  Ohio State University Comprehensive Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 5, 2008
• First Posted: January 9, 2008
• Study Start: February 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: June 8, 2015
• Results First Posted: June 8, 2015

Record last verified: 2015-06

Locations

US (1)