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

NCT00109863 | Completed Phase 2

• 9 other identifiers: CDR0000426431P30CA014520CO04601NCI-6304H-2004-0396NCI-2009-00051A533300R01CA032685SMPH\HUMAN ONCOLOGY\HUMAN ONCO
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma; stage IV melanoma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• 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

Study Arms (1)

Hu14.18-IL2 Treatment

EXPERIMENTAL

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.

Biological: hu14.18-IL2 fusion protein

Interventions

hu14.18-IL2 fusion protein BIOLOGICAL

Hu14.18-IL2 Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Melanoma

Interventions

lorukafusp alfa

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mark R. Albertini, MD

  University of Wisconsin, Madison

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2005
• First Posted: May 4, 2005
• Study Start: May 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: February 1, 2014
• Last Updated: November 19, 2019

Record last verified: 2015-02

Locations

US (1)