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Stage III MelanomaPhase 2NCT00082875

Cilengitide in Treating Patients With Unresectable or Metastatic Melanoma

A Phase 2 study testing cilengitide, pharmacological study and laboratory biomarker analysis in people with Stage III Melanoma and Stage IV Melanoma, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This randomized phase II trial is studying how well cilengitide works in treating patients with unresectable stage III or stage IV melanoma. Cilengitide may stop the growth of melanoma by stopping blood flow to the tumor. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stage III Melanoma, Stage IV Melanoma
What is being tested?
cilengitide, pharmacological study and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteUnited States
Study dates
Mar 2004to Jul 2006
Phase
Phase 2
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically or cytologically confirmed stage IV or unresectable stage III metastatic melanoma of cutaneous, mucosal or unknown origin
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 15 mm with conventional techniques or with spiral CT scan; in case of obviously visible cutaneous metastatic lesions, the margins of the lesions should be clearly defined and measured in at least one dimension as >= 10 mm
  • Patient may have received prior interferon therapy (only in an adjuvant setting for resected stage III melanoma) and/or up to 1 prior systemic treatment regimen (chemotherapy, biotherapy, or biochemotherapy) for stage IV disease; active vaccine therapy will not be considered as "prior systemic treatment"
  • Radiographic studies used to assess disease must have been performed within 21 days prior to registration; if a target lesion has been previously embolized, perfused or irradiated, there must be objective evidence of progression before start of therapy to be considered for response assessment
  • ECOG performance status ≤ 2 (or Karnofsky ≥ 60%)
  • Leukocytes >= 3,000/microL
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  • Absolute neutrophil count >= 1,500/microL
  • Platelets >= 100,000/microL
  • Total bilirubin =< 1.5 X institutional upper limit of normal
  • ALT(SGPT) =< 2.5 X institutional upper limit of normal
  • Creatinine =< 1.5 X institutional upper limit of normal
  • Patient must have a hemoglobin >= 9 gm/dL (this may be achieved by transfusion if needed) obtained within 14 days prior to registration; in case that PRBC transfusion is needed to obtain a hemoglobin level of >= 9 gm/dL, the hemoglobin level should not be reduced more than 1 gm/dL for at least 1 week
  • The effects of EMD 121974 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because antiangiogenic agents are known to 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; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Patients with metastatic melanoma of choroidal origin
  • Patients must not have received the following drugs prior to enrollment: endostatin, angiostatin, bevacizumab or any integrin-targeted drugs
  • Subjects who require concurrent treatment with a non-permitted medication (such as anticoagulant therapy other than for flushing of intravenous port device, or used for thrombosis prophylaxis)
  • Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered to grade 1 toxicity from adverse events due to agents administered more than 4 weeks earlier
  • Patients may not be receiving any other investigational agents
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events; however, the following is the exception; patients who have no radiographical evidence of recurrences in the brain for at least 3 months after the complete resection of the brain metastases or who have asymptomatic brain metastases stable for at least 3 months since the whole brain radiation therapy and/or stereotactic radiosurgery will be eligible for this study; patients must not require a steroid treatment for brain metastases
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  • Subjects with a history of wound-healing disorders, advanced coronary disease (such as unstable angina pectoris or arrhythmia LOWN IV [defined as 2 or more consecutive ventricular premature complexes], cardiac or cardiovascular abnormalities NYHA III/IV), or with a recent history (within 6 months) of peptic ulcer disease
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study because EMD 121974 is an antiangiogenic agent 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 EMD 121974, breastfeeding should be discontinued if the mother is treated with EMD 121974; lactating women must not breastfeed
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase 2 Study of EMD 121974 (Cilengitide, NSC 707544) in Patients With Metastatic Melanoma

This randomized phase II trial is studying how well cilengitide works in treating patients with unresectable stage III or stage IV melanoma. Cilengitide may stop the growth of melanoma by stopping blood flow to the tumor.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the clinical efficacy of EMD 121974 at two different doses in patients with metastatic melanoma by determining the progression-free survival rate at 8 weeks.

SECONDARY OBJECTIVES:

  1. To determine the response rate of EMD 121974 in patients with metastatic melanoma.

II. To determine the overall survival in patients who receive EMD 121974. III. To determine the safety and toxicity of EMD 121974 in patients with metastatic melanoma.

IV. To determine the population pharmacokinetics of EMD 121974. V. To determine the biological activity of EMD 121974 in melanoma cells of patients who are treated with the drug.

VI. To evaluate the use of optical imaging and functional dynamic imaging scans in assessing biological activity of EMD 121974.

OUTLINE: This is a randomized, double-blind study. Patients are stratified according to prior systemic treatment (yes vs no), visceral metastases (yes vs no), serum lactic dehydrogenase level (normal vs abnormal), and tumor integrin α_vβ_3 overexpression (yes vs no). Patients are randomized into 1 of 2 treatment arms.

ARM I: Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11*, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

NOTE: *For the first course only, treatment is omitted on day 11.

ARM II: Patients receive cilengitide as in arm I at a higher dose.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months thereafter.

Being tested
cilengitide, pharmacological study, laboratory biomarker analysis
Medical subject headings
Melanoma

What participants receive

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

  • cilengitideDrug

    Also called EMD 121974

    Given IV

  • pharmacological studyOther

    Also called pharmacological studies

    Correlative studies

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00082875
Study groupRoleWhat they receive
Arm IExperimentalPatients receive cilengitide IV over 1 hour on days 1, 4, 8, 11*, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. NOTE: *For the first course only, treatment is omitted on day 11
Receives: Drug: cilengitide; Other: pharmacological study; Other: laboratory biomarker analysis
Arm IIExperimentalPatients receive cilengitide as in arm I at a higher dose.
Receives: Drug: cilengitide; Other: pharmacological study; Other: laboratory biomarker analysis

What is being measured

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

  1. PFS

    Each dose of EMD 121974 will be analyzed separately.

    Measured: At 8 weeks

Secondary outcomes (5)

  1. Response rate, calculated by the ratio of the number of (CR + PR) / total number of treated patients

    Measured: Up to 4 years

  2. PFS

    For each dose of EMD 121974, Kaplan-Meier life table methods and Cox proportional hazards regression modeling will be utilized to analyze progression-free survival.

    Measured: Up to 4 years

  3. Overall survival

    For each dose of EMD 121974, Kaplan-Meier life table methods and Cox proportional hazards regression modeling will be utilized to analyze overall survival.

    Measured: Up to 4 years

  4. Incidence of adverse events graded according to CTCAE version 3.0

    Adverse events will be tabulated by dose of EMD 121974 and toxicity grade.

    Measured: Up to 4 years

  5. Population Pharmacokinetics of EMD 121974, including Cmax, tmax, AUClast, t1/2, AUCinf, CL, Vz

    Mean and SD will be estimated for each parameter except for tmax, where the median and range will be reported. Plasma concentrations and pharmacokinetic parameters for each dose will be summarized using descriptive statistics and the mean plasma concentrations for each dose will be plotted versus time. Pharmacokinetic parameters will be compared among doses using graphical and statistical analyses.

    Measured: Before and 2, 4, and 24 hours after dose of the first dose of courses 1 and 2 and before and 4 hours after dose of the third dose of courses 1 and 2

Timeline

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

  1. First posted19 May 2004 (estimated)
  2. Study startMar 2004
  3. Primary completionJul 2006

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00082875
Sponsor's protocol ID
NCI-2012-02884
Other IDs
2003-0988, 6387, N01CM62202
Status last verified
Jun 2013
First submitted
14 May 2004
Last updated
5 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cilengitide, pharmacological study and laboratory biomarker analysis in people with Stage III Melanoma and Stage IV Melanoma, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: At 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00082875.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2013.

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