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

NCT ID: NCT00006003

Last Updated: 2013-01-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-07-31

Brief 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

Detailed 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.

Conditions

Recurrent Melanoma; Stage IV Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (semaxanib)

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.

Group Type: EXPERIMENTAL

semaxanib

Intervention Type: DRUG

Given IV

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

semaxanib

Given IV

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

semoxind; SU5416; Sugen 5416

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Gajewski

Role: PRINCIPAL_INVESTIGATOR

University of Chicago Comprehensive Cancer Center

Locations

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

10395

Identifier Type: -

Identifier Source: secondary_id

N01CM17102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000068011

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02346

Identifier Type: -

Identifier Source: org_study_id