SU5416 in Treating Patients With Refractory or Relapsed Multiple Myeloma

Sponsor

Fox Chase Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00006013

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Duration (Months)

5.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Drug: semaxanib	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Trial of SU5416 as Treatment for Refractory/Relapsed Multiple Myeloma

Study Start Date :

Jun 1, 2000

Actual Primary Completion Date :

Jan 1, 2003

Actual Study Completion Date :

Jan 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612-9497
2	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
3	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
4	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232-6838