SU5416 in Treating Patients With Metastatic Melanoma That Has Been Previously Treated

Stage IV Melanoma Clinical Trial

Official title:

A Phase II Trial of SU5416 (NSC #696819) in Patients With Metastatic Melanoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00006003
• Other study ID #: NCI-2012-02346
• Secondary ID: 10395N01CM17102C
• Status: Terminated
• Phase: Phase 2
• First received: July 5, 2000
• Last updated: January 23, 2013
• Start date: July 2000

Study information

• Verified date: January 2013
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

SU5416 may stop the growth of malignant melanoma by stopping blood flow to the tumor. Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic melanoma that has been previously treated

Description:

PRIMARY OBJECTIVES:

I. Determine the objective response rate and stabilization of disease rates of patients with previously treated metastatic melanoma treated with SU5416.

II. Determine the toxicity of SU5416 in this patient population. III. Determine the median and overall survival and time to progression in these patients receiving this treatment.

OUTLINE: This is a multicenter study.

Patients receive SU5416 IV over 60 minutes twice weekly for 4 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression.

Patients are followed weekly for 4 weeks.

PROJECTED ACCRUAL: A total of 14-35 patients will be accrued for this study within 18-24 months.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. primary completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed melanoma with documented metastatic disease

• In transit metastases allowed

• Lesion accessible for biopsy

• Measurable disease

• Greater than 20 mm by conventional techniques ORgreater than 10 mm by spiral CT

• Documented progressive disease by radiologic study or physical examination

• Known history of CNS metastasis who have had treatment, are neurologicallystable, and do not require intravenous antibiotics or anticonvulsants eligibleprovided oral steroids are not required and brain scan (CT or MRI) showsabsence of active or residual disease

• If neurologic signs or symptoms suggestive of CNS metastasis, negative brain scan required

• Performance status - WHO 0-2

• At least 12 weeks

• WBC at least 3,000/mm^3

• Platelet count at least 100,000/mm^3

• Bilirubin no greater than 1.5 mg/dL

• Transaminases no greater than 2.5 times upper limit of normal

• Creatinine no greater than 1.5 mg/dL

• Creatinine clearance at least 60 mL/min

• No uncompensated coronary artery disease

• No history of myocardial infarction or severe/unstable angina within past 6 months

• No severe peripheral vascular disease associated with diabetes mellitus

• No deep venous or arterial thrombosis within past 3 months

• No pulmonary embolism within past 3 months

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other significant uncontrolled underlying medical or psychiatric illness

• No serious active infections

• No other malignancy within past 5 years except for curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix

• No history of severe allergic or anaphylactic reactions to paclitaxel or docetaxel

• No other concurrent chemotherapy

• No other concurrent investigational antineoplastic drugs

• See Disease Characteristics

• No prior radiotherapy to only site of measurable disease

• At least 4 weeks since prior radiotherapy and recovered

• No concurrent radiotherapy

• No greater than 1 prior therapy for metastatic disease

• At least 4 weeks since prior therapy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Recurrent Melanoma
• Stage IV Melanoma

Intervention

Drug:
• semaxanib
Given IV

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	University of Chicago Comprehensive Cancer Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate		Up to 3 years	No
Primary	Overall response rate (complete and partial responses)		Up to 3 years	No
Primary	Maintenance of stable disease		Up to 3 years	No
Primary	Treatment toxicity		Up to 4 weeks post treatment	Yes
Primary	Time to progression	Kaplan-Meier estimates will be calculated.	Up to 3 years	No
Primary	Survival	Kaplan-Meier estimates will be calculated.	Up to 3 years	No