Interleukin-2 in Treating Patients With Metastatic or Recurrent Kidney Cancer
NCT ID: NCT00002846
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
14 participants
INTERVENTIONAL
1995-09-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of low-dose interleukin-2 in treating patients with metastatic or recurrent kidney cancer.
Detailed Description
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* Assess the response rate and survival of patients with metastatic renal cell carcinoma treated with low-dose intravenous interleukin-2.
* Assess the toxicity associated with this treatment.
OUTLINE: Patients receive low-dose intravenous interleukin-2 every 8 hours for a maximum of 15 doses in week 1 and again in week 3. Stable and responding patients receive a second course beginning approximately 2 months after initiation of the first course. Responding patients may continue therapy every 2 months provided toxicity is limited.
Patients whose diseased kidney comprises the bulk of the tumor burden at entry undergo nephrectomy.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 14 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
conventional surgery
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed renal cell carcinoma (RCC) that is metastatic or recurrent
* No central nervous system or major nerve involvement
* No more than 25% estimated hepatic replacement by tumor on CT or MRI
* Measurable disease required
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 80%-100%
Life expectancy:
* Greater than 3 months
Hematopoietic:
* Platelet count at least 80,000/mm3
Hepatic:
* Bilirubin normal
* AST and ALT no greater than 3 times normal
Renal:
* Creatinine normal
Cardiovascular:
* Stress cardiac exam normal (exam performed in patients aged 50 and older and in those with potential cardiac disease suggested by history, physical exam, or EKG)
Pulmonary:
* FEV1 and VC greater than 65% of predicted (tests performed in patients with significant smoking history and in those with potential pulmonary disease suggested by history, physical exam, or x-ray)
Other:
* No sites of ongoing bleeding
* No HIV antibody or AIDS
* No hepatitis B antigen
* No systemic infection
* No requirement for steroids
* No psychiatric disease that precludes informed consent or safe administration of immunotherapy
* No second malignancy except:
* Basal cell carcinoma
* In situ cervical cancer
* Other cancer provided all evaluable lesions are documented RCC
* No pregnant or nursing women
* Effective contraception required of fertile women
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior interleukin-2 therapy
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* At least 28 days since therapy for RCC
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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Carolinas Medical Center
Charlotte, North Carolina, United States
Countries
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Other Identifiers
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CMC-09-95-15B
Identifier Type: -
Identifier Source: secondary_id
NCI-V96-1038
Identifier Type: -
Identifier Source: secondary_id
CDR0000065085
Identifier Type: -
Identifier Source: org_study_id