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Interleukin-2 in Treating Patients With Metastatic Melanoma - Article


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Melanoma

Melanoma cancer 




Clinical Trial: Interleukin-2 in Treating Patients With Metastatic Melanoma

This study is no longer recruiting patients.

Sponsored by: Blumenthal Cancer Center at Carolinas Medical Center
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells.

PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients who have metastatic melanoma.

Condition Treatment or Intervention Phase
Stage IV Melanoma
Recurrent Melanoma
 Drug: interleukin-2
Phase II

MedlinePlus related topics:  Melanoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Interleukin-2 in Metastatic Melanoma

Further Study Details: 

Study start: September 1995

OBJECTIVES: I. Evaluate the response and survival rates of patients with metastatic melanoma following induction with high-dose and maintenance with low-dose interleukin-2.

II. Assess the toxicity of this regimen.

PROTOCOL OUTLINE: All patients receive high-dose interleukin-2 over 24 hours, followed by low-dose interleukin-2 for 4 days in the absence of toxicity. Patients receive a second cycle beginning 9-13 days after completion of the first cycle, with response assessed approximately 2 months after initiating therapy. Patients with stable or responding disease receive a second course as above; those with a continued response may receive additional courses provided toxicity is limited.

Patients are followed for survival.

PROJECTED ACCRUAL: 20 patients will be entered.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Histologically proven melanoma that is metastatic; No tumor replacement of 25% or more of liver on CT or MRI; No involvement of the CNS or a major nerve
  • Measurable disease required

--Prior/Concurrent Therapy--

  • No prior interleukin-2; At least 28 days since treatment for melanoma

--Patient Characteristics--

  • Age: 18 and over
  • Performance status: Karnofsky 80%-100%
  • Life expectancy: More than 3 months
  • Hematopoietic: No coagulopathy (i.e., platelets less than 80,000)
  • Hepatic: Bilirubin normal
  • Renal: Creatinine normal
  • Cardiovascular: No abnormal cardiac stress test in patients over 50 years of age or with possible cardiac disease suggested by history, physical exam, or EKG
  • Pulmonary: FEV1 or VC greater than 65% of predicted in patients with significant smoking history or with suspected pulmonary disease by history, physical exam, or x-ray
  • 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; No pregnant or nursing women; Negative pregnancy test required of fertile women; Effective contraception required of fertile women

Location Information


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

Study chairs or principal investigators

Richard L. White, Jr.,  Study Chair,  Blumenthal Cancer Center at Carolinas Medical Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000065084; CMC-09-95-16B; NCI-V96-1037
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002845
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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December 2, 2009



Page Updated: October 15, 2009
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