PEG-Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer

Kidney Cancer Clinical Trial

Official title:

Phase II Trial of PEG-Intron in Patients With Advanced Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00045279
• Other study ID #: 01-143
• Secondary ID: CDR0000256464NCI
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2002
• Last updated: June 4, 2013
• Start date: April 2002
• Est. completion date: September 2005

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: PEG-interferon alfa-2b may stop the growth of kidney cancer by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating patients who have metastatic kidney cancer.

Description:

OBJECTIVES:

• Determine the efficacy of PEG-interferon alfa-2b in patients with metastatic renal cell carcinoma.

• Determine the time to disease progression in patients treated with this drug.

• Determine the safety of this drug in these patients.

• Determine the quality of life of patients treated with this drug.

• Determine the effect of this drug on biological surrogates of antitumor activity (basic fibroblast growth factor, vascular endothelial growth factor, and interleukin-6 serum levels) in these patients.

OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at 2 weeks and at 2, 4, 8, and 12 months after initiation of study therapy, and then at completion of study therapy.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 15 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed renal cell carcinoma

• Metastatic disease

• No prior therapy for advanced disease

• Tumor sample available for molecular analysis with prior registration on MSKCC IRB # 89-076

• Bidimensionally measurable disease

• No brain metastases unless completely resected and without evidence of recurrence for at least six months

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm3

• Platelet count at least 100,000/mm3

Hepatic

• Bilirubin no greater than 1.5 mg/dL

• SGOT no greater than 2.5 times upper limit of normal (unless due to hepatic metastases)

• Hepatitis B surface antigen negative

• Hepatitis C negative

Renal

• Creatinine no greater than 2 mg/dL

Cardiovascular

• No severe cardiac disease

• No New York Heart Association class III or IV cardiac disease

• No myocardial infarction within the past 12 months

• No ventricular tachyarrhythmias requiring ongoing treatment

• No unstable angina

Pulmonary

• No severe asthma requiring chronic systemic steroids

Other

• HIV negative

• Negative pregnancy test

• Fertile patients must use effective contraception

• No malignancy within the past 2 years except basal cell or squamous cell skin cancer, superficial bladder cancer, or localized prostate cancer

• Patients who have undergone potentially curative therapy and have been deemed to be at low risk for recurrence are eligible

• No medically significant psychiatric disease (e.g., endogenous depression, psychosis, or bipolar disease) requiring hospitalization

• No prior or active autoimmune disease

• Medically controlled diabetes or thyroid dysfunction allowed

• No clinically significant acute viral or bacterial infection that requires specific therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior interleukin-2

• No prior interferon alfa

• No concurrent cytokines or biological response modifiers except epoetin alfa in the case of hematologic compromise

• No concurrent tumor vaccines

• No concurrent monoclonal antibodies

• No concurrent bone marrow/stem cell transplantation

Chemotherapy

• No concurrent cytotoxic agents

Endocrine therapy

• No concurrent high-dose systemic steroids

• Concurrent low-dose corticosteroids (e.g., asthma inhalers, topical creams, or intra-articular injections) allowed

• No concurrent hormonal therapy (including megestrol)

• Concurrent hormone replacement therapy or oral contraceptives allowed

Radiotherapy

• At least 4 weeks since prior radiotherapy

• No concurrent radiotherapy

Surgery

• See Disease Characteristics

• At least 4 weeks since prior major surgery

• Concurrent nephrectomy allowed

Other

• At least 14 days since prior anti-infectious therapy

• No other concurrent investigational drugs

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Biological:
• PEG-interferon alfa-2b

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Feldman DR, Kondagunta GV, Schwartz L, Patil S, Ishill N, DeLuca J, Russo P, Motzer RJ. Phase II trial of pegylated interferon-alpha 2b in patients with advanced renal cell carcinoma. Clin Genitourin Cancer. 2008 Mar;6(1):25-30. — View Citation

Motzer RJ, Rakhit A, Thompson J, Gurney H, Selby P, Figlin R, Negrier S, Ernst S, Siebels M, Ginsberg M, Rittweger K, Hooftman L. Phase II trial of branched peginterferon-alpha 2a (40 kDa) for patients with advanced renal cell carcinoma. Ann Oncol. 2002 N — View Citation