SU5416 in Treating Patients With Refractory or Relapsed Multiple Myeloma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00006013
First received: July 5, 2000
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: semaxanib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of SU5416 as Treatment for Refractory/Relapsed Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Enrollment: 21
Study Start Date: June 2000
Study Completion Date: January 2003
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006013

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Study Chair: Mitchell R. Smith, MD, PhD Fox Chase Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00006013     History of Changes
Other Study ID Numbers: FCCC-00009, CDR0000068022, NCI-58
Study First Received: July 5, 2000
Last Updated: July 10, 2013
Health Authority: United States: Federal Government

Keywords provided by Fox Chase Cancer Center:
refractory multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on October 16, 2014