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Thalidomide and SU5416 in Treating Patients With Metastatic Melanoma

Primary Purpose

Melanoma (Skin)

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

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, recurrent melanoma

Eligibility Criteria

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

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

Sites / Locations

  • University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 6, 2001
Last Updated
February 8, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00017316
Brief Title
Thalidomide and SU5416 in Treating Patients With Metastatic Melanoma
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
August 2002
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
September 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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage IV melanoma, recurrent 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
Arm I
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
semaxanib
Intervention Type
Drug
Intervention Name(s)
thalidomide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric K. Rowinsky, MD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Study Chair
Facility Information:
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284-7811
Country
United States

12. IPD Sharing Statement

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Thalidomide and SU5416 in Treating Patients With Metastatic Melanoma

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