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Cilengitide in Treating Patients With Unresectable or Metastatic Melanoma
This study has been completed.
First Received: May 14, 2004   Last Updated: March 11, 2009   History of Changes
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00082875
  Purpose

RATIONALE: Cilengitide may stop the growth of melanoma by stopping blood flow to the tumor.

PURPOSE: This randomized phase II trial is studying how well cilengitide works in treating patients with unresectable stage III or stage IV melanoma.


Condition Intervention Phase
Melanoma (Skin)
Drug: cilengitide
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control
Official Title: A Phase II Study Of EMD 121974 (Cilengitide, NSC 707544) In Patients With Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival measured at 8 weeks after completion of study treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate measured at 6 months [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: March 2004
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the clinical efficacy of cilengitide at 2 different doses, in terms of the 8-week progression-free survival rate, in patients with unresectable stage III or stage IV melanoma.

Secondary

  • Determine the response rate in patients treated with this drug.
  • Determine the overall survival rate of patients treated with this drug.
  • Determine the safety and toxicity of this drug in these patients.
  • Determine the population pharmacokinetics of this drug in these patients.
  • Determine the biological activity of this drug in these patients.

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.

PROJECTED ACCRUAL: A total of 26-56 patients (13-28 per treatment arm) will be accrued for this study within 14-20 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed melanoma

    • Unresectable stage III or stage IV disease
    • Cutaneous, mucosal, or unknown origin
  • Measurable disease

    • At least one unidimensional lesion ≥ 15 mm by conventional techniques or spiral CT scan
    • In case of obviously visible cutaneous metastatic lesions, at least one unidimensional lesion ≥ 10 mm with clearly defined margins
    • No prior embolization, perfusion, or radiotherapy to target lesion unless there is objective evidence of disease progression
  • No metastatic melanoma of choroidal origin
  • No known brain metastases

    • Patients who have no radiographical evidence of recurrence in the brain for at least 3 months after prior complete resection of brain metastases OR who have asymptomatic brain metastases that are stable for at least 3 months after prior whole brain radiotherapy and/or stereotactic radiosurgery AND do not require steroids are eligible

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • Not specified

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL (transfusion allowed, provided the hemoglobin level has not decreased ≥ 1 g/dL within 1 week)

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT ≤ 2.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia, including LOWN IV arrhythmia (defined as 2 or more consecutive ventricular premature complexes)
  • No advanced coronary artery disease
  • No New York Heart Association class III or IV cardiac disease

Other

  • No prior wound-healing disorders
  • No peptic ulcer disease within the past 6 months
  • No ongoing or active infection
  • No other concurrent uncontrolled illness
  • No psychiatric illness or social situation that would preclude study compliance
  • No other malignancy within the past 5 years except for the following:

    • Adequately treated basal cell or squamous cell skin cancer
    • Carcinoma in situ of the cervix
    • Adequately treated stage I or II cancer currently in complete remission
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior interferon alfa in the adjuvant setting for resected stage III melanoma allowed
  • No prior endostatin, angiostatin, bevacizumab or any integrin-targeted drugs
  • No more than 1 prior systemic biotherapy or biochemotherapy regimen for stage IV disease

    • Active vaccine therapy is not considered prior systemic therapy

Chemotherapy

  • See Biologic therapy
  • No more than 1 prior systemic chemotherapy regimen for stage IV disease
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy

  • See Disease Characteristics

Radiotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy and recovered

Surgery

  • See Disease Characteristics

Other

  • Prior embolization or perfusion allowed provided there is objective evidence of disease progression for response assessment
  • No concurrent anticoagulant therapy (e.g., warfarin, heparin, or hirudin derivatives)

    • Concurrent low molecular weight heparin or other low-dose anticoagulants for flushing IV port devices or for thrombosis prophylaxis allowed
  • No other concurrent anticancer therapy
  • No other concurrent investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00082875

Locations
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Kevin Kim, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000360886, MDA-2003-0988, NCI-6387
Study First Received: May 14, 2004
Last Updated: March 11, 2009
ClinicalTrials.gov Identifier: NCT00082875     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III melanoma
stage IV melanoma

Study placed in the following topic categories:
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on September 03, 2009