Status:
COMPLETED
Pilot Study of Denileukin Diftitox Plus High-Dose IL-2 for Patients With Metastatic Renal Cancer
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
RATIONALE: Combinations of biological substances in denileukin diftitox may be able to carry tumor-killing substances directly to kidney cancer cells. Interleukin-2 may stimulate the white blood cells...
Detailed Description
OBJECTIVES: Primary * Determine the toxic effects of denileukin diftitox and high-dose interleukin-2 in patients with metastatic renal cell cancer. Secondary * Perform transforming growth factor (...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Documented histologically confirmed metastatic renal cell carcinoma
- Clear cell histology
- Disease must be measurable as defined by lesions that can be accurately measured in at least one dimension with longest diameter \> 20 mm using conventional techniques or \> 10 mm with spiral CT scan
- Must have at least one measurable lesion
- If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology
- Clinical lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes)
- The following are considered nonmeasurable lesions:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Cystic lesions
- Abdominal masses not confirmed and followed by imaging techniques
- No CNS metastases
- PATIENT CHARACTERISTICS:
- ECOG performance status \< 2
- Life expectancy of at least 4 months
- Serum creatinine \< 2.0 mg/dL OR creatinine clearance \> 50 mL/min
- Total bilirubin normal
- Platelets \> 100,000/mm³
- WBC \> 3,500/mm³
- No evidence of congestive heart failure
- No symptoms of coronary artery disease
- No serious cardiac arrhythmias
- A pretreatment cardiac stress test must be performed within 42 days of IL-2 treatment if any cardiac symptoms are present (patients with documented ischemia on the pretreatment cardiac stress test will be excluded from the study)
- Adequate pulmonary reserve
- Pulmonary function tests (PFTs) must be performed within 42 days of IL-2 treatment
- FEV\_1 \> 2.0 liters of \> 75% predicted for height and age
- Patients unable to perform PFTs will be excluded
- Women who are pregnant or lactating are not eligible
- Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study
- Negative pregnancy test
- No known HIV-positive patients
- No evidence of active infection requiring antibiotic therapy
- Must not have a contraindication to treatment with pressor agents
- Must not have any significant medical disease that, in the opinion of the investigator, may interfere with completion of the study
- No history of another malignancy within the past 5 years other than basal cell skin cancer
- PRIOR CONCURRENT THERAPY:
- Recovered from all toxic effects of prior therapy
- Must not currently receive chronic medication for asthma
- No prior interleukin-2 (IL-2) therapy
- No prior organ allografts
- No systemic corticosteroids in the 4 weeks prior to treatment
- No concurrent systemic steroids
- No radiotherapy, chemotherapy, or immunotherapy in the 4 weeks prior to the first dose of study treatment
- No concurrent radiotherapy, chemotherapy, or other immunotherapy
- No previous investigational agent within 4 weeks prior to the start of study treatment
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00278369
Start Date
April 1 2005
End Date
September 1 2010
Last Update
May 22 2013
Active Locations (1)
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1
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013