- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00017316
Thalidomide and SU5416 in Treating Patients With Metastatic Melanoma
A Phase II, Pharmacologic and Biologic Study of Escalating Doses of Thalidomide (NSC #66847) Administered Orally Once a Day in Combination With a Fixed Dose of SU5416 (NSC #696819) in Patients With Metastatic Melanoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
I. Determine the efficacy of thalidomide and SU5416 in patients with metastatic melanoma.
II. Determine the quantitative and qualitative toxic effects of this regimen in these patients.
III. Evaluate the pharmacokinetics of this regimen in these patients. IV. Determine the complete and partial responses and response duration in patients treated with this regimen.
V. Assess disease-free survival at 6 months of patients treated with this regimen.
OUTLINE:
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Texas
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San Antonio, Texas, United States, 78284-7811
- University of Texas Health Science Center at San Antonio
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I
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.
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Eric K. Rowinsky, MD, The University of Texas Health Science Center at San Antonio
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Thalidomide
Other Study ID Numbers
- CDR0000068677
- UTHSC-IDD-99-27
- SACI-IDD-99-27
- NCI-66
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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