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Hu14.18-Interleukin-2 Fusion Protein in Treating Patients With Advanced Melanoma

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
hu14.18-IL2 fusion protein
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage IV melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hu14.18-IL2 Treatment

Arm Description

Hu14.18-IL2 will be given on days 1, 2, and 3 of each course of therapy as a 4 hour continuous IV infusion at a daily dose of 6 mg/m2. Treatment courses will be repeated every 28 days at the same dose.

Outcomes

Primary Outcome Measures

Objective response rate and duration of response by clinical exam and radiology studies after every 2 courses

Secondary Outcome Measures

Adverse events by clinical assessment daily during treatment and weekly after completion of study treatment
Immunologic activation induced by hu14.18-interleukin-2 after every 2 courses
Induction of anti-idiotypic antibodies on days 1, 3, 4, and 8 of each course

Full Information

First Posted
May 3, 2005
Last Updated
November 15, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00109863
Brief Title
Hu14.18-Interleukin-2 Fusion Protein in Treating Patients With Advanced Melanoma
Official Title
Phase II Trial of Hu14.18-IL2 (EMD 273063) in Subjects With Advanced Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
recurrent melanoma, stage IV melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hu14.18-IL2 Treatment
Arm Type
Experimental
Arm Description
Hu14.18-IL2 will be given on days 1, 2, and 3 of each course of therapy as a 4 hour continuous IV infusion at a daily dose of 6 mg/m2. Treatment courses will be repeated every 28 days at the same dose.
Intervention Type
Biological
Intervention Name(s)
hu14.18-IL2 fusion protein
Primary Outcome Measure Information:
Title
Objective response rate and duration of response by clinical exam and radiology studies after every 2 courses
Secondary Outcome Measure Information:
Title
Adverse events by clinical assessment daily during treatment and weekly after completion of study treatment
Title
Immunologic activation induced by hu14.18-interleukin-2 after every 2 courses
Title
Induction of anti-idiotypic antibodies on days 1, 3, 4, and 8 of each course

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark R. Albertini, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Study Chair
Facility Information:
Facility Name
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States

12. IPD Sharing Statement

Links:
URL
https://cancer.wisc.edu
Description
University of Wisconsin Carbone Cancer Center

Learn more about this trial

Hu14.18-Interleukin-2 Fusion Protein in Treating Patients With Advanced Melanoma

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