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Interleukin-2 in Treating Patients With Metastatic Melanoma
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: NCT00002845
  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 Intervention Phase
Melanoma (Skin)
Biological: aldesleukin
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: TREATMENT OF METASTATIC MELANOMA WITH RECOMBINANT INTERLEUKIN-2

Resource links provided by NLM:


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

Estimated Enrollment: 20
Study Start Date: September 1995
Detailed Description:

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.

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 older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

PRIOR CONCURRENT THERAPY: No prior interleukin-2 At least 28 days since treatment for melanoma

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002845

Locations
United States, North Carolina
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: CDR0000065084, CMC-09-95-16B, NCI-V96-1037
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00002845     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Anti-Infective Agents
Anti-HIV Agents
Antiviral Agents
Recurrence
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Aldesleukin
Anti-Retroviral Agents
Interleukin-2
Analgesics, Non-Narcotic
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Neuroepithelioma
Nevus
Analgesics
Peripheral Nervous System Agents

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-HIV Agents
Neoplasms by Histologic Type
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Antiviral Agents
Pharmacologic Actions
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Aldesleukin
Anti-Retroviral Agents
Sensory System Agents
Analgesics, Non-Narcotic
Interleukin-2
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Nevi and Melanomas
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 02, 2009