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Interferon Alfa and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsored by: Blumenthal Cancer Center at Carolinas Medical Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002847
  Purpose

RATIONALE: Biological therapies use different ways to stimulate the immune system to try to stop cancer cells from growing. Combining interferon alfa and interleukin-2 may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of interferon alfa and interleukin-2 in treating patients with metastatic kidney cancer.


Condition Intervention Phase
Kidney Cancer
Biological: aldesleukin
Biological: recombinant interferon alfa
Procedure: conventional surgery
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH SUBCUTANEOUS RECOMBINANT INTERLEUKIN-2 AND INTERFERON ALPHA

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 14
Study Start Date: September 1995
Detailed Description:

OBJECTIVES:

  • Evaluate the response and disease-free survival of patients with metastatic renal cell carcinoma treated with subcutaneous interleukin-2 and interferon alfa.
  • Assess the toxicity of this regimen.

OUTLINE: Patients undergo nephrectomy if the diseased kidney makes up the bulk of the tumor burden.

All patients receive subcutaneous interferon alfa on day 1 and interleukin-2 on days 3-5 of week 1, followed by reduced doses of interferon alfa and interleukin-2 on days 1, 3, and 5 of weeks 2-6. Patients are assessed for response approximately 2 months after initiating therapy. Patients with stable or responding disease undergo a second course; those who continue to respond may receive additional therapy provided toxicity is limited.

Patients are followed for survival.

PROJECTED ACCRUAL: 14 patients will be entered.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven renal cell cancer that is metastatic

    • No greater than 50% estimated hepatic replacement by tumor on CT or MRI
    • No symptomatic involvement of the CNS or a major nerve
  • Measurable disease required
  • Ineligible for treatment with low-dose interleukin-2 on another CMC protocol

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 50%-100%

Life expectancy:

  • More than 3 months

Hematopoietic:

  • No coagulopathy (i.e., platelet count less than 80,000/mm3)

Hepatic:

  • AST and ALT no greater than 5 times normal

Renal:

  • Creatinine less than 4.0 mg/dL

Cardiovascular:

  • No symptomatic angina
  • No untreated coronary artery disease
  • No refractory arrhythmia
  • No abnormal left ventricular function

Pulmonary:

  • No dyspnea on minimal exertion

Other:

  • No site of ongoing bleeding
  • No systemic infection
  • No HIV antibody
  • No HBsAg
  • No requirement for steroids
  • No psychiatric disease that precludes informed consent or protocol treatment
  • No second malignancy except:

    • Basal cell skin carcinoma
    • Carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior interleukin-2

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • At least 28 days since prior treatment for renal cell cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002847

Locations
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Sponsors and Collaborators
Blumenthal Cancer Center at Carolinas Medical Center
Investigators
Study Chair: Richard L. White, MD Blumenthal Cancer Center at Carolinas Medical Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000065086, CMC-09-95-14B, NCI-V96-1039
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00002847     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
recurrent renal cell cancer

Study placed in the following topic categories:
Urinary Tract Neoplasm
Anti-Infective Agents
Interferon Type I, Recombinant
Immunologic Factors
Urogenital Neoplasms
Urologic Neoplasms
Renal Cancer
Anti-Retroviral Agents
Urologic Diseases
Kidney Neoplasms
Kidney Diseases
Analgesics
Interferon-alpha
Kidney Cancer
Anti-HIV Agents
Interferons
Antiviral Agents
Angiogenesis Inhibitors
Recurrence
Carcinoma
Aldesleukin
Interleukin-2
Analgesics, Non-Narcotic
Carcinoma, Renal Cell
Peripheral Nervous System Agents
Adenocarcinoma
Interferon Alfa-2a
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Anti-Infective Agents
Interferon Type I, Recombinant
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Neoplasms by Site
Anti-Retroviral Agents
Urologic Diseases
Sensory System Agents
Kidney Neoplasms
Therapeutic Uses
Analgesics
Growth Inhibitors
Angiogenesis Modulating Agents
Kidney Diseases
Interferon-alpha
Anti-HIV Agents
Neoplasms by Histologic Type
Growth Substances
Interferons
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Aldesleukin
Analgesics, Non-Narcotic
Interleukin-2

ClinicalTrials.gov processed this record on September 02, 2009