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Sponsored by: |
Blumenthal Cancer Center at Carolinas Medical Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002845 |
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 |
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Melanoma (Skin) |
Biological: aldesleukin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | TREATMENT OF METASTATIC MELANOMA WITH RECOMBINANT INTERLEUKIN-2 |
Estimated Enrollment: | 20 |
Study Start Date: | 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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
United States, North Carolina | |
Carolinas Medical Center | |
Charlotte, North Carolina, United States, 28232-2861 |
Study Chair: | Richard L. White, MD | Blumenthal Cancer Center at Carolinas Medical Center |
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 |
stage IV melanoma recurrent melanoma |
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 |
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 |