NCT00006013

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2000

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 5, 2000

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 25, 2003

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

2.6 years

First QC Date

July 5, 2000

Last Update Submit

July 10, 2013

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Keywords

refractory multiple myeloma

Interventions

semaxanibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms, Plasma Cell

Interventions

Semaxinib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Mitchell R. Smith, MD, PhD

    Fox Chase Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2000

First Posted

June 25, 2003

Study Start

June 1, 2000

Primary Completion

January 1, 2003

Study Completion

January 1, 2003

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations

US(4)