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Ciliary Body and Choroid Melanoma, Medium/Large SizePhase 2NCT01413191

Cixutumumab in Treating Patients With Metastatic Melanoma of the Eye

A Phase 2 study testing Cixutumumab and Laboratory biomarker analysis in people with Ciliary Body and Choroid Melanoma, Medium/Large Size and Ciliary Body and Choroid Melanoma, Small Size, run by National Cancer Institute (NCI) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 17 years and older
What is being tested?
Cixutumumab and Laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
2 sitesUnited States
Study dates
Aug 2011to Jun 2014
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Patients must have no angina at rest
  • The effects of IMC-A12 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because monoclonal antibodies could be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for 3 months after the last dose of IMC-A12; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Both men and women and members of all races and ethnic groups are eligible for this trial
  • Patients must have the ability to understand and the willingness to sign a written informed consent form indicating that they are aware of the investigational nature of this study and in keeping with the policies of the institution

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • M D Anderson Cancer Center

    Houston, Texas, 77030

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: Phase II Study of IMC-A12 in Metastatic Uveal Melanoma

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the response rate of metastatic uveal melanoma when treated with IMC-A12 (cixutumumab).

II. To determine the safety and tolerability of IMC-A12 in patients with metastatic uveal melanoma.

SECONDARY OBJECTIVES:

  1. To determine the disease control rate of patients treated with IMC-A12. II. To determine the duration of response of patients treated with IMC-A12. III. To determine the progression-free survival and overall survival of patients treated with IMC-A12.

TERTIARY OBJECTIVES:

  1. To correlate the presence of GNAQ and GNA11 mutations with response to IMC-A12.

II. To correlate the expression of IGF-1R with response to IMC-A12. III. To determine the effect of IMC-A12 on expression of proteins involved in initiation, growth, and spread of uveal melanoma cells.

IV. To determine resistance mechanisms to IMC-A12.

OUTLINE: This is a multicenter study.

Patients receive cixutumumab intravenously (IV) over 1 hour on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Archived and fresh tumor tissue and serum samples may be collected for correlative studies.

After completion of study treatment, patients are followed up for 30 days and then every 3 months for 1 year.

Being tested
Cixutumumab, Laboratory biomarker analysis
Medical subject headings
Uveal Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CixutumumabBiological

    Also called anti-IGF-1R recombinant monoclonal antibody IMC-A12, IMC-A12

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

  • Laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT01413191
Study groupRoleWhat they receive
CixutumumabTreatmentExperimentalCixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
Receives: Biological: Cixutumumab; Other: Laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to 2 years

Secondary outcomes (5)

  1. Disease Control Rate

    Disease Control Rate is the proportion of subjects with a confirmed complete or partial response of any duration or stable disease ≥3 months in duration.

    Measured: Up to 2 years

  2. Duration of Response

    Duration of response will be summarized by using descriptive statistics. Median duration of response will be estimated by using the Kaplan-Meier method.

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

  3. Progression-free Survival (PFS)

    Measured: Up to 2 years

  4. Overall Survival (OS)

    Measured: Up to 2 years

  5. Durable Response Rate

    Durable Response Rate is the proportion of subjects with a confirmed complete or partial response ≥ 6 months in duration.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionMar 2013
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01413191
Sponsor's protocol ID
NCI-2011-02228
Other IDs
NCI-2011-02228, 2010-0451, 8832, P30CA016672, N01CM00039
Status last verified
Feb 2020
First submitted
9 Aug 2011
Last updated
19 Feb 2020

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