SU5416 in Treating Patients With Metastatic Melanoma That Has Been Previously Treated - Full Text View

Purpose

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

Condition	Intervention	Phase
Recurrent Melanoma Stage IV Melanoma	Drug: semaxanib Other: laboratory biomarker analysis	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Trial of SU5416 (NSC #696819) in Patients With Metastatic Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Complete response rate [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Overall response rate (complete and partial responses) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Maintenance of stable disease [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Treatment toxicity [ Time Frame: Up to 4 weeks post treatment ] [ Designated as safety issue: Yes ]
Time to progression [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Kaplan-Meier estimates will be calculated.
Survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Kaplan-Meier estimates will be calculated.

Enrollment:	35
Study Start Date:	July 2000
Primary Completion Date:	July 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Drug: semaxanib Given IV Other Names: semoxind SU5416 Sugen 5416 Other: laboratory biomarker analysis Correlative studies

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006003

Locations

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

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Thomas Gajewski

University of Chicago Comprehensive Cancer Center

More Information

No publications provided

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006003 History of Changes
Other Study ID Numbers:	NCI-2012-02346, 10395, N01CM17102, CDR0000068011
Study First Received:	July 5, 2000
Last Updated:	January 23, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
SU 5416
Angiogenesis Inhibitors

Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013