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Study Summary
No. DM02-641:.......Lymphoma......Anas Younes......Lymphoma/Myeloma
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Study Summary Title
Study Summary
Number:		DM02-641
Study Title:Phase II Epothilone B Analog BMS-247550 for Patients with Relapsed Aggressive non-Hodgkin's Lymphoma (NHL)
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Physician New Patient Referral
Name:Anas YounesPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Lymphoma/MyelomaReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2860
Contact us about clinical trials
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General Information
Disease Group:LymphomaSupported By:N/A
Phase of Study:Phase IIReturn
Visit:		Weekly
Treatment
Agents:		BMS-247550Home Care:None
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:		None
Description/
Intervention:		The goal of this research is to learn the effect of the drug on this disease.
The safety of this treatment will also be studied.
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Study Objectives / Outcomes
To determine the overall response rate and response duration to BMS-247550 in patients with relapsed chemosensitive or refractory aggressive non-Hodgkin's lymphomas (NHL).
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Study Status Information
Study Activation / Registration Date:06/09/2003
IRB Review and Approval Date:01/15/2003
Study Type:Therapeutic
Recruitment Status:Terminated
Projected Accrual:76
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Relapsed chemosensitive or refractory aggressive NHL.

2) Measurable disease.

3) greater than or equal to 18 years of age.

4) No cytotoxic chemotherapy within the past 4 weeks.

5) ECOG performance status 0-2.

6) For patients with chemo refractory disease, no more than 1 prior chemotherapy.

7) Must have a good marrow reserve: WBC greater than or equal to 3000K/mL, ANC greater than or equal to 1200/mL, PLT greater than or equal to 1000,000 K/mL.

8) Total bilirubin and SGOT/SGPT less than or equal to 2.5 x normal.

9) Creatinine less than or equal to 1.5 mg/dL or creatinine clearance greater than or equal to 60 mL/min.

10) No known CNS involvement.

11) Non-pregnant and non-lactating.

12) No HIV patients taking anti-retroviral therapy.
Exclusion Criteria:1) Concurrent malignancy.

2) Poorly controlled comorbiditied (e.g.New York Heart association Class III or IV cardiac disease, active uncontrolled bacterial, viral, or fungal infections.)

3) Peripheral neuropathy > grade 1 by Common Toxicity Criteria (CTC) 2.0
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Links
Registration Number: NCT00058019
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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