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

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

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

Study Overview

• Status: Terminated
• Conditions: Recurrent Melanoma; Stage IV Melanoma
• Intervention / Treatment: Other: laboratory biomarker analysis; Drug: semaxanib

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637-1470
      • University of Chicago Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: laboratory biomarker analysis; Correlative studies; Drug: semaxanib; Given IV; Other Names: SU5416; semoxind; Sugen 5416

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete response rate		Up to 3 years
Overall response rate (complete and partial responses)		Up to 3 years
Maintenance of stable disease		Up to 3 years
Treatment toxicity		Up to 4 weeks post treatment
Time to progression	Kaplan-Meier estimates will be calculated.	Up to 3 years
Survival	Kaplan-Meier estimates will be calculated.	Up to 3 years

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Thomas Gajewski, University of Chicago Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: July 1, 2000
• Primary Completion (Actual): July 1, 2003

Study Registration Dates

• First Submitted: July 5, 2000
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): January 24, 2013
• Last Update Submitted That Met QC Criteria: January 23, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Semaxinib
• Other Study ID Numbers: NCI-2012-02346; N01CM17102 (U.S. NIH Grant/Contract); 10395 (Registry Identifier: DAIDS ES); CDR0000068011 (Registry Identifier: PDQ (Physician Data Query))