NCT Number: NCT00006013
SU5416 in Treating Patients With Refractory or Relapsed Multiple Myeloma
RATIONALE: SU5416 may stop the growth of multiple myeloma by stopping blood flow to the cancer cells.
PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have refractory or relapsed multiple myeloma.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
About this study
OBJECTIVES: I. Determine the response rate and response duration of patients with refractory or relapsed multiple myeloma treated with SU5416. II. Determine the toxicity of SU5416 in this patient population.
OUTLINE: This is a multicenter study. Patients receive SU5416 IV over 1 hour twice weekly. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed for survival.
PROJECTED ACCRUAL: A total of 20-38 patients will be accrued for this study within 2 years.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
DISEASE CHARACTERISTICS: Histologically confirmed multiple myeloma with an elevated monoclonal protein in serum and/or urine No history of CNS lesion or CNS bleed
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Cytopenias secondary to multiple myeloma involvement of bone marrow allowed Cytopenias not due to multiple myeloma require: WBC at least 3,000/mm3 Platelet count at least 75,000/mm3 Hepatic: Transaminases no greater than 2 times upper limit of normal Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No congestive heart failure, severe peripheral vascular disease, or significant arrhythmia No poorly controlled systolic or diastolic hypertension No uncompensated coronary artery disease No history of myocardial infarction or severe/unstable angina within past 6 months No known hypercoagulable state or deep venous or arterial thrombosis within past 3 months Pulmonary: No pulmonary embolism within past 3 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No other severe medical or psychiatric condition (e.g., active peptic ulcer, active infection, or history of severe alcohol or drug abuse) No known hypersensitivity to paclitaxel or Cremophor
PRIOR CONCURRENT THERAPY: Biologic therapy: See Chemotherapy Chemotherapy: At least 1 but no more than 3 prior chemotherapy regimens Induction followed by high dose therapy with stem cell support considered a single treatment regimen Tandem courses of high dose therapy considered as 2 regimens Endocrine therapy: At least 1 prior regimen containing steroids Radiotherapy: Prior radiotherapy for symptom control allowed Surgery: At least 3 weeks since prior major surgery At least 1 year since prior coronary artery surgery, angioplasty, or stent placement No prior brain surgery Other: No other concurrent investigational drugs Concurrent bisphosphonates (e.g., pamidronate) allowed
Treatment and study plan
Sponsors and collaborators
Lead sponsor
Fox Chase Cancer Center
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Phase II Trial of SU5416 as Treatment for Refractory/Relapsed Multiple Myeloma
Important dates
- Study start
- 2000
- Primary completion
- 2003
- Study completion
- 2003
- First posted
- Jun 25, 2003
- Registry last updated
- Jul 11, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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