Melanoma |
Melanoma cancer |
Clinical Trial: Interleukin-2 in Treating Patients With Metastatic Melanoma
This study is no longer recruiting patients.
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
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
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
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
Resources
- "Hidden" Melanomas (American Academy of Dermatology)
- ABCDs of Melanoma Detection (American Academy of Dermatology)

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