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

Primary Purpose

Recurrent Melanoma, Stage IV Melanoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
semaxanib
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (semaxanib)

Arm Description

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.

Outcomes

Primary Outcome Measures

Complete response rate
Overall response rate (complete and partial responses)
Maintenance of stable disease
Treatment toxicity
Time to progression
Kaplan-Meier estimates will be calculated.
Survival
Kaplan-Meier estimates will be calculated.

Secondary Outcome Measures

Full Information

First Posted
July 5, 2000
Last Updated
January 23, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006003
Brief Title
SU5416 in Treating Patients With Metastatic Melanoma That Has Been Previously Treated
Official Title
A Phase II Trial of SU5416 (NSC #696819) in Patients With Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Administratively complete.
Study Start Date
July 2000 (undefined)
Primary Completion Date
July 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Melanoma, Stage IV Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (semaxanib)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
semaxanib
Other Intervention Name(s)
semoxind, SU5416, Sugen 5416
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Complete response rate
Time Frame
Up to 3 years
Title
Overall response rate (complete and partial responses)
Time Frame
Up to 3 years
Title
Maintenance of stable disease
Time Frame
Up to 3 years
Title
Treatment toxicity
Time Frame
Up to 4 weeks post treatment
Title
Time to progression
Description
Kaplan-Meier estimates will be calculated.
Time Frame
Up to 3 years
Title
Survival
Description
Kaplan-Meier estimates will be calculated.
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Gajewski
Organizational Affiliation
University of Chicago Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States

12. IPD Sharing Statement

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

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