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Hu14.18-Interleukin-2 Fusion Protein in Treating Patients With Advanced Melanoma
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: University of Wisconsin, Madison
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00109863
  Purpose

RATIONALE: Biological therapies, such as hu14.18-interleukin-2 fusion protein, may stimulate the immune system in different ways and stop tumor cells from growing.

PURPOSE: This phase II trial is studying how well hu14.18-interleukin-2 fusion protein works in treating patients with advanced melanoma.


Condition Intervention Phase
Melanoma (Skin)
Drug: hu14.18-IL2 fusion protein
Phase II

MedlinePlus related topics: Cancer Melanoma
Drug Information available for: Interleukin-2 Denileukin diftitox
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial of Hu14.18-IL2 (EMD 273063) in Subjects With Advanced Melanoma

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

Primary Outcome Measures:
  • Objective response rate and duration of response by clinical exam and radiology studies after every 2 courses [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events by clinical assessment daily during treatment and weekly after completion of study treatment [ Designated as safety issue: Yes ]
  • Immunologic activation induced by hu14.18-interleukin-2 after every 2 courses [ Designated as safety issue: No ]
  • Induction of anti-idiotypic antibodies on days 1, 3, 4, and 8 of each course [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2005
Estimated Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the clinical antitumor activity of hu14.18-interleukin-2 fusion protein in patients with advanced melanoma.
  • Determine the duration of response in patients treated with this drug.

Secondary

  • Determine the adverse events in patients treated with this drug.
  • Determine the in vivo immunologic activation in patients treated with this drug.
  • Determine the induction of anti-hu14.18 and anti-interleukin-2 antibodies in patients treated with this drug.
  • Determine tumor antigen recognition by this drug in select patients with cutaneous metastatic tumors, as measured by binding of the drug to the cutaneous metastatic tumor and microscopic changes (including immune cell density and phenotype) of the tumor tissue.

OUTLINE: Patients receive hu14.18-interleukin-2 fusion protein IV over 4 hours on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of symptomatic disease progression or unacceptable toxicity. Patients then undergo disease reassessment. Patients with an objective partial or complete clinical response or stable disease receive 2 additional courses of treatment.

PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 7-15 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant melanoma

    • Advanced disease
  • Measurable disease by clinical assessment or imaging
  • No known standard curative therapy exists

    • Disease no longer controlled by surgery, chemotherapy, or radiotherapy
  • No clinically detectable pleural effusion or ascites
  • No brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC ≥ 3,500/mm^3 OR
  • Granulocyte count ≥ 2,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10.0 g/dL

Hepatic

  • AST and ALT < 2 times normal
  • Bilirubin < 2.0 mg/dL
  • Hepatitis B surface antigen negative
  • No clinical evidence of hepatitis

Renal

  • Creatinine < 2.0 mg/dL OR
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • No ischemic cardiac disease, congestive heart failure, or myocardial infarction within the past 6 months
  • No uncontrolled cardiac rhythm disturbance
  • No myocardial ischemia or heart failure by exercise radionuclide scan for patients with a history of cardiac disease, significant risk factors for coronary artery disease, or ≥ 65 years of age

Pulmonary

  • Pulmonary function normal by exercise radionuclide scan for patients with a history of cardiac disease, significant risk factors for coronary artery disease, or ≥ 65 years of age

Immunologic

  • HIV negative
  • No known hypersensitivity to the study drug, Tween-80®, or human immunoglobulin
  • No uncontrolled active infection

Neurologic

  • No seizure disorder
  • No objective peripheral neuropathy ≥ grade 2
  • No clinically significant neurologic deficit

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Must consent to the placement of a central venous line OR demonstrate stable peripheral IV access
  • Must be willing and able to discontinue antihypertensive medications (if advised to do so) on the days of study drug infusion
  • No uncontrolled active peptic ulcer
  • No known grade 4 side effects related to prior interleukin-2
  • No diabetes mellitus that has required systemic therapy (e.g., oral hypoglycemic agents or insulin) within the past 3 months
  • No other significant illness
  • No significant psychiatric disability

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior monoclonal antibodies for biologic therapy, tumor imaging, purging of autologous bone marrow/stem cells for re-infusion, or for any other reason allowed provided there is documented absence of detectable antibody to hu14.18 by serology
  • No concurrent growth factors

Chemotherapy

  • No immediate requirement for palliative chemotherapy
  • No concurrent anticancer chemotherapy

Endocrine therapy

  • More than 2 weeks since prior and no concurrent corticosteroids (e.g., dexamethasone)
  • No immediate requirement for palliative hormonal therapy

Radiotherapy

  • No immediate requirement for palliative radiotherapy

    • Concurrent palliative radiotherapy to localized painful lesions allowed provided ≥ 1 measurable or evaluable lesion is not irradiated AND the irradiated lesion is not used to assess tumor response

Surgery

  • More than 3 weeks since prior major surgery
  • No prior organ allografts

Other

  • More than 2 weeks since other prior and no concurrent immunosuppressive drugs
  • No prior standard or experimental systemic therapy for stage IV melanoma
  • No concurrent myelosuppressive antineoplastic drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109863

Locations
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Study Chair: Mark R. Albertini, MD University of Wisconsin, Madison
  More Information

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

Study ID Numbers: CDR0000426431, WCCC-CO-04601, NCI-6304, WCCC-H-2004-0396
Study First Received: May 3, 2005
Last Updated: January 14, 2009
ClinicalTrials.gov Identifier: NCT00109863  
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Recurrence
Melanoma
Neuroendocrine Tumors
Antibodies, Monoclonal
Neuroectodermal Tumors
Antibodies
Interleukin-2
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Denileukin diftitox
Neuroepithelioma
Nevus
Immunoglobulins

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Pharmacologic Actions
Neoplasms
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Nevi and Melanomas
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009