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Aldesleukin in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2008
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00331617
  Purpose

RATIONALE: Biological therapies, such as aldesleukin, may stimulate the white blood cells to kill tumor cells. Giving aldesleukin at high doses may kill more tumor cells.

PURPOSE: This phase II trial is studying how well high-dose aldesleukin works in treating patients with metastatic melanoma or metastatic kidney cancer.


Condition Intervention Phase
Kidney Cancer
Melanoma (Skin)
Drug: aldesleukin
Phase II

MedlinePlus related topics: Cancer Kidney Cancer Melanoma
Drug Information available for: Aldesleukin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Studies on the Mechanism of Action of High-Dose IL-2 in Metastatic Melanoma and Renal Cell Cancer

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

Primary Outcome Measures:
  • Clinical outcome as measured by RECIST [ Designated as safety issue: No ]

Estimated Enrollment: 245
Study Start Date: March 2006
Detailed Description:

OBJECTIVES:

  • Identify serum protein levels and lymphocyte phenotypes that may be associated with or predictive of tumor regression in patients with metastatic melanoma or metastatic renal cell cancer treated with high-dose aldesleukin.

OUTLINE: This is a pilot study.

Patients receive high-dose aldesleukin IV over 15 minutes 3 times daily for 4 days. Approximately 7-10 days later, patients receive additional aldesleukin as above 3 times daily for 4 days (course 1). Courses repeat every 2 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 245 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed melanoma or renal cell cancer

    • Metastatic disease
    • No more than 25% estimated hepatic replacement by tumor
  • Measurable disease
  • Eligible for high-dose aldesleukin therapy
  • No untreated or clinically significant (i.e., because of size or presence of edema) tumor involvement of CNS or major nerve compression

PATIENT CHARACTERISTICS:

  • Life expectancy > 3 months
  • ECOG performance status 0-1
  • Creatinine ≤ 1.4 mg/dL
  • Bilirubin ≤ 2.0 mg/dL (< 3.0 mg/dL for Gilbert's syndrome)
  • Platelet count > 100,000/mm^3
  • Absolute neutrophil count > 1,000/mm^3
  • ALT and AST < 3 times upper limit of normal
  • No significant second malignancy within the past 3 years or that would likely require intervention within 1 year of study entry
  • No significant psychiatric disease that would preclude study treatment
  • No systemic infections, coagulation disorders or evidence of active bleeding, or other major medical illnesses of the cardiovascular, respiratory, or immune system
  • Not pregnant
  • Fertile patients must use effective contraception
  • No HIV positivity
  • No hepatitis B or C positivity
  • FEV_1 or vital capacity > 65% of predicted

    • Patients with a significant smoking history (> 20 pk/years) or suspicion of pulmonary disease must undergo pulmonary function screening
  • LVEF ≥ 45%

    • Must be determined in all patients ≥ 60 years old and others as clinically indicated
  • No active cardiac ischemia or significantly abnormal EKG

PRIOR CONCURRENT THERAPY:

  • At least 28 days since prior therapy except focal radiation for bone lesion
  • No prior aldesleukin therapy
  • No concurrent systemic or inhaled steroids

    • Concurrent topical steroid therapy allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00331617

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Patient Recruitment     866-820-4505        
Sponsors and Collaborators
Investigators
Principal Investigator: James C. Yang, MD NCI - Surgery Branch
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000473925, NCI-06-C-0115, NCI-P6910
Study First Received: May 30, 2006
Last Updated: December 11, 2008
ClinicalTrials.gov Identifier: NCT00331617  
Health Authority: Unspecified

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

Study placed in the following topic categories:
Urogenital Neoplasms
Renal cancer
Kidney cancer
Urologic Neoplasms
Recurrence
Melanoma
Carcinoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Aldesleukin
Urologic Diseases
Kidney Neoplasms
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Carcinoma, Renal Cell
Neuroepithelioma
Nevus
Kidney Diseases
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Anti-Infective Agents
Neoplasms
Anti-HIV Agents
Neoplasms by Site
Neoplasms by Histologic Type
Anti-Retroviral Agents
Antineoplastic Agents
Therapeutic Uses
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009