Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Cilengitide in Treating Patients With Unresectable or Metastatic Melanoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI MDA-2003-0988 6387, NCI-6387, NCT00082875

Objectives

Primary

1. 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

1. Determine the response rate in patients treated with this drug.
2. Determine the overall survival rate of patients treated with this drug.
3. Determine the safety and toxicity of this drug in these patients.
4. Determine the population pharmacokinetics of this drug in these patients.
5. Determine the biological activity of this drug in these patients.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

  OR

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 3,000/mm³
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

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

Outcomes

Progression-free survival measured at 8 weeks after completion of study treatment

Overall response rate measured at 6 months

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_vβ₃ 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.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Kevin Kim, MD, Protocol chair		Ph: 713-792-2921; 800-392-1611 Email: kkim@mdanderson.org

Registry Information
Official Title		A Phase II Study Of EMD 121974 (Cilengitide, NSC 707544) In Patients With Metastatic Melanoma
Trial Start Date		2004-03-14
Registered in ClinicalTrials.gov		NCT00082875
Date Submitted to PDQ		2004-03-04
Information Last Verified		2006-05-31
NCI Grant/Contract Number		CA16672, CM17003

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