Monoclonal Antibody Therapy and Interleukin-2 in Treating Patients With Metastatic Melanoma

NCT00058279 | Completed Phase 1

• 2 other identifiers: CDR0000287211NCI-03-C-0109
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Biological therapies, such as MDX-010, work in different ways to stimulate the immune system and stop tumor cells from growing. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining monoclonal antibody therapy with interleukin-2 may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining monoclonal antibody therapy with interleukin-2 in treating patients who have metastatic melanoma.

Conditions

Intraocular Melanoma; Melanoma (Skin)

Keywords

stage IV melanoma; extraocular extension melanoma; recurrent melanoma; iris melanoma; ciliary body and choroid melanoma, medium/large size; ciliary body and choroid melanoma, small size; recurrent intraocular melanoma

Interventions

aldesleukin BIOLOGICAL

ipilimumab BIOLOGICAL

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed stage IV melanoma * Mucosal or ocular melanoma also eligible * Clinically evaluable disease * At least 1 site of measurable disease PATIENT CHARACTERISTICS: Age * 16 and over Performance status * ECOG 0-1 Life expectancy * At least 3 months Hematopoietic * WBC at least 2,500/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL * Hematocrit at least 30% Hepatic * Bilirubin no greater than upper limit of normal (ULN)\* (less than 3.0 mg/dL in patients with Gilbert's syndrome) * AST no greater than 3 times ULN\* * Hepatitis B surface antigen negative * Hepatitis C antibody nonreactive * No evidence or history of significant hepatic disease that would preclude safe administration of high-dose IL-2 NOTE: \*Unless attributable to disease Renal * Creatinine no greater than 2.0 mg/dL * No evidence or history of significant renal disease that would preclude safe administration of high-dose IL-2 Cardiovascular * No evidence or history of significant cardiac disease that would preclude safe administration of high-dose IL-2 * Thallium stress test normal (for patients over 50 years of age or with a history of cardiovascular disease) Pulmonary * No evidence or history of significant pulmonary disease that would preclude safe administration of high-dose IL-2 Immunologic * HIV negative * No autoimmune disease (including uveitis and autoimmune inflammatory eye disease) * No active infection Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix * No evidence or history of significant gastrointestinal disease that would preclude safe administration of high-dose IL-2 * No evidence or history of psychiatric disease that would preclude safe administration of high-dose IL-2 * No other underlying medical condition that would make the administration of the study drug hazardous or obscure the interpretation of adverse events * No other concurrent medical condition that would preclude study entry PRIOR CONCURRENT THERAPY: Biologic therapy * At least 3 weeks since prior immunotherapy for melanoma and recovered * No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4) * No prior high-dose (at least 600,000 IU/kg every 8 hours) interleukin-2 (IL-2) Chemotherapy * At least 3 weeks since prior chemotherapy for melanoma and recovered * No concurrent chemotherapy Endocrine therapy * At least 3 weeks since prior hormonal therapy for melanoma and recovered * At least 4 weeks since prior corticosteroids * No concurrent systemic or topical corticosteroids Radiotherapy * At least 3 weeks since prior radiotherapy for melanoma and recovered Surgery * Not specified Other * No concurrent immunosuppressive agents (e.g., cyclosporine or its analog)

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (2)

• Maker AV, Phan GQ, Attia P, Yang JC, Sherry RM, Topalian SL, Kammula US, Royal RE, Haworth LR, Levy C, Kleiner D, Mavroukakis SA, Yellin M, Rosenberg SA. Tumor regression and autoimmunity in patients treated with cytotoxic T lymphocyte-associated antigen 4 blockade and interleukin 2: a phase I/II study. Ann Surg Oncol. 2005 Dec;12(12):1005-16. doi: 10.1245/ASO.2005.03.536. Epub 2005 Oct 21.

  PMID: 16283570 RESULT

• Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.

  PMID: 25667295 DERIVED

MeSH Terms

Conditions

Uveal Melanoma; Melanoma

Interventions

aldesleukin; Ipilimumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Steven A. Rosenberg, MD, PhD

  NCI - Surgery Branch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 7, 2003
• First Posted: April 9, 2003
• Study Start: February 1, 2003
• Study Completion: August 1, 2006
• Last Updated: June 20, 2013

Record last verified: 2006-08

Locations

US (1)