Thalidomide and SU5416 in Treating Patients With Metastatic Melanoma - Full Text View

Purpose

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.

Condition	Intervention	Phase
Melanoma (Skin)	Drug: semaxanib Drug: thalidomide	Phase 2

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Thalidomide

U.S. FDA Resources

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

Enrollment:	35
Study Start Date:	March 2001
Primary Completion Date:	September 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Drug: semaxanib Drug: thalidomide

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.

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00017316

Locations

United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Eric K. Rowinsky, MD

University of Texas Health Science Center at San Antonio

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00017316 History of Changes
Other Study ID Numbers:	CDR0000068677, UTHSC-IDD-99-27, SACI-IDD-99-27, NCI-66
Study First Received:	June 6, 2001
Last Updated:	February 8, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

stage IV melanoma
recurrent melanoma

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
Thalidomide
SU 5416
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013