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

NCT00045279 | Completed Phase 2

• 3 other identifiers: 01-143CDR0000256464NCI-G-02-2102
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Cancer

Keywords

stage IV renal cell cancer

Interventions

PEG-interferon alfa-2b BIOLOGICAL

Eligibility Criteria

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

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

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related 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. doi: 10.3816/cgc.2008.n.004.

  PMID: 18501079 RESULT

• 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 Nov;13(11):1799-805. doi: 10.1093/annonc/mdf288.

  PMID: 12419754 RESULT

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

peginterferon alfa-2b

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

Study Officials

• Robert J. Motzer, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 6, 2002
• First Posted: January 27, 2003
• Study Start: April 1, 2002
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: June 5, 2013

Record last verified: 2013-06

Locations

US (1)