Search / Trial NCT00002846

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

Launched by BLUMENTHAL CANCER CENTER AT CAROLINAS MEDICAL CENTER · Jan 26, 2003

Trial Information

Current as of November 03, 2024

Unknown status

Keywords

Stage Iv Renal Cell Cancer Recurrent Renal Cell Cancer

ClinConnect Summary

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 b...

Gender

ALL

Eligibility 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

About Blumenthal Cancer Center At Carolinas Medical Center

The Blumenthal Cancer Center at Carolinas Medical Center is a leading institution dedicated to advancing cancer research and treatment through innovative clinical trials. As part of the Atrium Health network, the center integrates cutting-edge technology with a patient-centered approach, offering comprehensive care that includes personalized treatment plans and access to the latest therapeutic options. With a multidisciplinary team of experts, the Blumenthal Cancer Center focuses on improving patient outcomes and enhancing the understanding of cancer biology, making significant contributions to the field of oncology.

Locations

Charlotte, North Carolina, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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