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Home > "I" Clinical Trials Conditions > Interleukin-2 in Treating Patients With Metastatic or Recurrent Kidney Cancer

Interleukin-2 in Treating Patients With Metastatic or Recurrent Kidney Cancer



Interleukin-2 in Treating Patients With Metastatic or Recurrent Kidney Cancer

For Condition: recurrent renal cell cancer,stage 4 renal cell cancer
Status: No longer recruiting
Sponsor(s): Blumenthal Cancer Center at Carolinas Medical Center ,
Synopsis: RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells. PURPOSE: Phase II trial to study the effectiveness of low-dose interleukin-2 in treating patients with metastatic or recurrent kidney cancer.
Details: OBJECTIVES: - 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
RichardWhite,  Study Chair,  Blumenthal Cancer Center at Carolinas Medical Center

Carolinas Medical Center
Charlotte,  North Carolina,  28232-2861
United States
 


Additional Information:
Study ID Numbers:  CDR0000065085;  CMC-09-95-15B,NCI-V96-1038
Study Start Date: 
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002846

Other Stage 4 Renal Cell Cancer Studies:
1. SU5416 and Interferon alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer

2. Fluorouracil and Biological Therapy in Treating Patients With Metastatic Kidney or Colorectal Cancer

3. Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Unresectable Kidney Cancer

4. Sargramostim in Treating Patients With Kidney Cancer That Has Spread to the Lung

5. Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer

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Interleukin-2 in Treating Patients With Metastatic or Recurrent Kidney Cancer
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