Interferon Alfa (IFN-Alpha-1b) in Renal Cancer With Metastatic Kidney Cancer

NCT00278174 | Completed Phase 2 DMC

• 3 other identifiers: CASE15804P30CA043703CCF-7752
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Interferon alfa may interfere with the growth of tumor cells and slow the growth of kidney cancer. PURPOSE: This phase II trial is studying how well interferon alfa works in treating patients with metastatic kidney cancer.

Conditions

Kidney Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Safety

• Efficacy

Interventions

recombinant interferon alpha-1b BIOLOGICAL

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed predominantly renal clear cell carcinoma * Clinical evidence of OR biopsy-proven metastatic disease to a site or sites distant from the primary tumor * Must have measurable disease, defined as ≥ 1 unidimensionally measurable lesion measured as ≥ 20 mm with conventional techniques OR as ≥ 10 mm with spiral CT scan * Good- or intermediate-risk category as defined by having ≤ 2 of the following factors: * Time from initial diagnosis to treatment \< 1 year * Karnofsky performance status \< 80% * Hemoglobin \< lower limit of normal * Corrected calcium \> 10.0 mg/dL * Lactate dehydrogenase (LDH) \> 1.5 times upper limit of normal (ULN) * No major clinical ascites or pleural effusion * No CNS metastases by neurologic exam and CT scan or MRI PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy ≥ 3 months * WBC ≥ 3,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.5 g/dL * Creatinine ≤ 1.5 mg/dL (2.0 mg/dL in post-nephrectomy patients) * Calcium normal * Total bilirubin ≤ 1.5 mg/dL * AST ≤ 3.0 times normal * Alkaline phosphatase ≤ 2.5 times normal (10 times ULN in presence of bone metastases) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception prior to and for the duration of study treatment * No history of serious cardiac arrhythmia, congestive heart failure, angina pectoris, or other severe cardiovascular disease (i.e., New York Heart Association class III or IV) * No known positivity for HIV or hepatitis B surface antigen * No history of seizure disorders * No local and/or systemic infections requiring antibiotics within 28 days prior to study entry * No other malignancy except basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the uterine cervix, or any malignancy treated with curative intent and in complete remission for \> 3 years PRIOR CONCURRENT THERAPY: * No prior organ allografts * No prior interferon * No prior cytokine-based therapy for metastatic disease * Prior radiotherapy is allowed for the control of pain from skeletal lesions provided treatment was completed \> 28 days prior to study entry and patient has recovered * No major surgery requiring general anesthesia within 28 days prior to study entry * No more than 2 prior therapies for metastatic disease * No concurrent palliative radiotherapy * No concurrent chemotherapy * No concurrent hormonal therapy except for hormones administered for nondisease-related conditions (e.g., insulin for diabetes) * No concurrent steroid use except ongoing replacement therapy with physiologic doses of corticosteroids * No concurrent dexamethasone or other steroidal anti-emetics or anti-inflammatories * No other concurrent anticancer therapy * No concurrent aspirin or barbiturates * No other concurrent investigational agents

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
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

interferon-alfa-1b

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

• Ronald M. Bukowski, MD

  The Cleveland Clinic

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: January 16, 2006
• First Posted: January 18, 2006
• Study Start: February 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: May 4, 2011

Record last verified: 2011-05

Locations

US (1)