Overview

SU5416 in Treating Patients With Refractory or Relapsed Multiple Myeloma

Status:
Completed
Trial end date:
2003-01-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fox Chase Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Semaxinib
Criteria
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