High-Dose Intravenous Interleukin-2 in Treating Patients With Metastatic Renal Cell Carcinoma (Kidney Cancer) That Has Not Responded to Previous Low-Dose Intravenous or Subcutaneous Interleukin-2
NCT ID: NCT00080977
Last Updated: 2013-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
INTERVENTIONAL
1998-06-30
Brief Summary
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PURPOSE: This phase II trial is studying how well high-dose intravenous interleukin-2 works in treating patients with metastatic renal cell carcinoma that has not responded to previous low-dose intravenous or subcutaneous interleukin-2.
Detailed Description
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* Determine the response rate (complete, partial, and minor) in patients with metastatic renal cell carcinoma who failed prior low-dose intravenous or subcutaneous interleukin-2 (IL-2) when treated with high-dose intravenous IL-2.
* Determine the overall survival, disease-free survival, and time to progression in patients treated with this drug.
* Determine the toxicity of this drug in these patients.
OUTLINE: This is a pilot study.
Patients receive high-dose interleukin-2 IV every 8 hours for 15 doses followed 7-10 days later by another 15 doses (course 1).
Patients are assesed for response 2 months after initiation of treatment. Patients with responding or stable disease receive a second course of therapy. Patients with an ongoing response receive subsequent courses of treatment in the absence of unacceptable toxicity.
Patients are followed every 6 months for survival.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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aldesleukin
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed renal cell carcinoma
* Metastatic disease
* No pure papillary or sarcomatoid variants
* Measurable disease
* Failed prior subcutaneous OR intravenous (dose ≤ 50,000 IU/kg/day) interleukin-2
* Documented disease progression
* No estimated hepatic replacement by tumor \> 25% by CT scan or MRI
* No tumor involving the CNS or a major nerve
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 80-100%
Life expectancy
* More than 3 months
Hematopoietic
* Platelet count ≥ 80,000/mm\^3
* No sites of ongoing bleeding
Hepatic
* See Disease Characteristics
* Bilirubin ≤ 1.4 mg/dL
* AST and ALT ≤ 3 times normal
* PT or PTT INR ≤ 1.2
* Hepatitis B surface antigen negative
* Hepatitis C virus negative
* No coagulation disorders
Renal
* Creatinine ≤ 1.6 mg/dL
Cardiovascular
* No ongoing ischemia\*
* No cardiac dysfunction\*
* No abnormal ejection fraction\* NOTE: \*A cardiac stress test is indicated for all patients ≥ 50 years of age and for any patient with possible cardiac disease as suggested by history, physical exam, or electrocardiogram
Pulmonary
* FEV\_1 ≤ 65% of predicted\*
* Vital capacity ≤ 65% of predicted\* NOTE: \*Pulmonary function tests are to be performed on any patient with a significant smoking history or suspected pulmonary disease either by history, physical exam, or radiograph
Other
* HIV negative
* No AIDS
* No systemic infections
* No other malignancy except carcinoma in situ
* No psychiatric illness that would preclude study participation or compliance
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
Chemotherapy
* Not specified
Endocrine therapy
* No concurrent steroids
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* More than 28 days since other prior treatment for renal cell cancer
* No concurrent immunosuppressive agents
18 Years
ALL
No
Sponsors
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Blumenthal Cancer Center at Carolinas Medical Center
OTHER
Principal Investigators
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Richard L. White, MD
Role: STUDY_CHAIR
Blumenthal Cancer Center at Carolinas Medical Center
Locations
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Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Countries
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Other Identifiers
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CMC-10-01-01AH
Identifier Type: -
Identifier Source: secondary_id
CDR0000357581
Identifier Type: -
Identifier Source: org_study_id