Clinical trial · Interventional
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
NCT00017316CI-TRIAL-00009416completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| semaxanib | Drug | — | UNRESOLVED |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- 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.
- interventionNames
- Drug: semaxanib
- Drug: thalidomide
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.