Cixutumumab in Treating Patients With Metastatic Melanoma of the Eye

NCT01413191 | Completed Phase 2 Results

• 5 other identifiers: NCI-2011-022282010-04518832P30CA016672N01CM00039
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

This phase II trial studies how well giving cixutumumab works in treating patients with metastatic melanoma of the eye. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

Conditions

Ciliary Body and Choroid Melanoma, Medium/Large Size; Ciliary Body and Choroid Melanoma, Small Size; Iris Melanoma; Metastatic Intraocular Melanoma; Recurrent Intraocular Melanoma; Stage IV Intraocular Melanoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Response

  Response rate is the percentage of subjects with a confirmed complete or partial response using revised Response Evaluation Criteria in Solid Tumors (RECIST) where changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria: Complete Response (CR): Disappearance all target lesions; pathological lymph nodes reduction in short axis to \<10 mm. Partial Response (PR): 30% or \> decrease in sum diameters of target lesions, reference baseline sum diameters. Progressive Disease (PD): 20% or \> increase in sum diameters of target lesions, reference smallest sum on study (includes baseline sum if smallest on study); and sum must demonstrate absolute increase of 5+ mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum diameters while on study.

  Baseline to 2 years

Secondary Outcomes (5)

• Disease Control Rate

  Up to 2 years

• Duration of Response

  From the date criteria are first met for complete or partial response until the first date of documented progression, assessed up to 2 years

• Progression-free Survival (PFS)

  Up to 2 years

• Overall Survival (OS)

  Up to 2 years

• Durable Response Rate

  Up to 2 years

Other Outcomes (1)

• Tumor Shrinkage for All Efficacy-evaluable Patients

  Up to 2 years

Study Arms (1)

CixutumumabTreatment

EXPERIMENTAL

Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.

Biological: Cixutumumab; Other: Laboratory biomarker analysis

Interventions

Cixutumumab BIOLOGICAL

10 mg/kg IV infusion over 1 hour every 2 weeks with treatment cycle defined as 4 weeks

Also known as: anti-IGF-1R recombinant monoclonal antibody IMC-A12, IMC-A12

CixutumumabTreatment

Laboratory biomarker analysis OTHER

Correlative studies

CixutumumabTreatment

Eligibility Criteria

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

You may qualify if:

• Patients must have a history of uveal melanoma and documented metastatic disease
• Patients must have at least one unidimensionally measurable lesion; if this is a cutaneous lesion it must be at least 10 mm by caliper measure; if it is a visceral or nodal or soft tissue lesion, it must be clearly measurable \> 20 mm with conventional techniques or \> 10 mm with spiral CT scan; bone lesions are not considered measurable
• One prior systemic chemotherapy and any number of immunotherapies or vaccine therapies are allowed; prior treatment with hepatic arterial chemotherapy infusion or perfusion or chemoembolization of liver metastasis is allowed; prior treatment with radiation therapy is allowed but not more than 3000 cGy to fields including substantial marrow; patients are not required to have had prior therapy
• At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy unless patients have progressed during therapy; if progression occurred during therapy, patient must have recovered from any side effects
• At least 4 weeks (28 days) since prior radiotherapy and prior adjuvant chemotherapy
• Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
• Patients must have a life expectancy of at least 3 months
• Leukocytes \> 3,000/mm3
• Absolute neutrophil count ≥ 1,500/mm3
• Hemoglobin ≥ 9.0 g/dL
• Platelets ≥ 100,000/mm3
• Aspartate transaminase-alanine transaminase ratio (AST(SGOT)/ALT(SGPT)) ≤ 3 times institutional upper limit of normal (ULN); ≤ 5 times institutional ULN if liver metastases present
• Total bilirubin \< 1.5 times institutional ULN
• Creatinine \< 1.5 times institutional ULN OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
• Fasting serum glucose \< 120 mg/dL or \< institutional ULN

You may not qualify if:

• Patients whose site of primary melanoma is not uveal
• Patients who have a current history of neoplasm other than the entry diagnosis except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or other cancers treated for cure and with a disease-free survival longer than 5 years
• Patients with symptomatic central nervous system metastasis including those with central nervous system (CNS) metastasis who require oral steroids for cerebral edema or have progression on CT/MRI
• Patients who are pregnant or nursing and patients who are not practicing an acceptable method of birth control; patients may not breast-feed while on this study; pregnant women are excluded from this study because IMC-A12 is a monoclonal antibody with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with IMC-A12, breastfeeding women are excluded
• Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals)
• Patients with poorly controlled diabetes mellitus; patients with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range (fasting \< 120 mg/dL or below institutional ULN) and that they are on a stable dietary or therapeutic regimen for this condition
• Patients with unstable or serious concurrent medical conditions are excluded; examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent
• Patients with one or more of the following as the only manifestations of disease are ineligible: leptomeningeal disease, ascites, pleural/pericardial effusions, carcinomatous lymphangitis
• Patients with Gilbert's Syndrome
• Patients must not have had major surgery within the past 14 days
• Patients must not receive any concurrent chemotherapy or immunotherapy while on study; only palliative radiotherapy is permitted to symptomatic lesions in which event the irradiated lesions may not be considered target or non-target lesions for response; palliative radiation immediately before or during the study is acceptable provided there is evaluable disease that has been radiated; palliative radiation is acceptable provided that the irradiated lesions are not used to determine response assessment
• HIV-positive patients with an absolute CD4 count \< 300 K/uL
• Patients may not be receiving any other investigational agents
• Patients with a history of treatment with other agents targeting the insulin-like growth factor pathway
• Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to IMC-A12

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Official Website

MeSH Terms

Conditions

Uveal Melanoma

Interventions

cixutumumab

Condition Hierarchy (Ancestors)

Melanoma; 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

Results Point of Contact

• Title: Dr. Sapna Patel, MD - Associate Professor, Melanoma Medical Oncology
• Organization: UT MD Anderson Cancer Center

SPPatel@mdanderson.org

713-792-2921

Study Officials

• Sapna Patel

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: August 10, 2011
• Study Start: August 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: June 1, 2014
• Last Updated: February 19, 2020
• Results First Posted: July 20, 2015

Record last verified: 2020-02

Locations

US (2)