NCT00017316

Brief Summary

Phase II trial to study the effectiveness of combining thalidomide and SU5416 in treating patients who have metastatic melanoma. Thalidomide combined with SU5416 may stop the growth of metastatic melanoma by stopping blood flow to the tumor.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2001

Completed
2 years until next milestone

First Posted

Study publicly available on registry

June 12, 2003

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
Last Updated

February 11, 2013

Status Verified

August 1, 2002

Enrollment Period

2.5 years

First QC Date

June 6, 2001

Last Update Submit

February 8, 2013

Conditions

Melanoma (Skin)

Keywords

stage IV melanomarecurrent melanoma

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive SU5416 IV over 1 hour twice weekly and oral thalidomide daily beginning 1 day after the first dose of SU5416. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Drug: semaxanibDrug: thalidomide

Interventions

semaxanibDRUG
Arm I
thalidomideDRUG
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic melanoma * Bidimensionally measurable disease by MRI, CT scan, or chest x-ray * No active brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * More than 12 weeks Hematopoietic: * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 8.5 g/dL Hepatic: * PT/PTT normal * Bilirubin no greater than 1.5 mg/dL * SGOT/SGPT no greater than 2.5 times upper limit of normal Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * No uncompensated coronary artery disease by electrocardiogram or physical exam * No myocardial infarction or severe or unstable angina within the past 6 months * No deep venous thrombosis within the past 3 months * No arterial thrombosis within the past 6 months Pulmonary: * No pulmonary embolism within the past 6 months Other: * HIV negative * No active infection * No medical, psychological, or social problem that would preclude study participation * No history of gastrointestinal disorder that would interfere with absorption or swallowing of study medication * No emotional disorder or substance abuse * No diabetes mellitus with severe peripheral vascular disease * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 forms of effective contraception for 4 weeks before, during, and for 4 weeks after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: * No more than 1 prior biologic regimen * No concurrent biologic response modifiers * No concurrent hematopoietic growth factor support * Concurrent epoetin alfa allowed Chemotherapy: * No concurrent cytotoxic agents Endocrine therapy: * No concurrent anticancer hormonal therapy except megestrol acetate for appetite stimulation Radiotherapy: * No prior large field radiotherapy to more than 20% total bone marrow * No concurrent radiotherapy Surgery: * At least 14 days since major surgery * No prior major upper gastrointestinal surgery Other: * No other concurrent investigational therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

SemaxinibThalidomide

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Eric K. Rowinsky, MD

    The University of Texas Health Science Center at San Antonio

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2001

First Posted

June 12, 2003

Study Start

March 1, 2001

Primary Completion

September 1, 2003

Last Updated

February 11, 2013

Record last verified: 2002-08

Locations

US(1)