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Study Summary
No. ID03-0004:.......Lymphoma......Barbara Pro......Lymphoma/Myeloma
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Study Summary Title
Study Summary
Number:		ID03-0004
Study Title:A Phase II Study of the Efficacy of the HCVIDDOXIL Regimen in Patients with Newly Diagnosed Peripheral T Cell Lymphoma
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Physician New Patient Referral
Name:Barbara ProPatients 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:		Return visits are for every 2 cycles during therapy for restaging studies, then
every 3 months during the first year, every 4 months during the second year,
every 6 months during the 3rd and 4th years, and every year thereafter.
Treatment
Agents:		ARA-C
Citrovorum Factor
Cyclophosphamide
Dexamethasone
Doxil
Mesna
Methotrexate
Vincristine		Home Care:Treatment can be given at home. CBC differential & platelets every week.
Other lab tests as clinically indicated. Prophylaxis with antibacterial,
antifungal, and antiviral therapy. G-CSF prophylaxis. Transfusion of blood
products as needed.
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		Cycle 1 = 4 days; Cycle 2 = 4 days. Cycles are repeated q-21 days
Cycles 1 & 2 to be done mostly as outpatient whenever possible.
Description/
Intervention:		The goal of this clinical research study is to learn if treatment with two
types of chemotherapy combinations can help to control peripheral T-cell
lymphoma.
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Study Objectives / Outcomes
To evaluate the progression-free survival (PFS) following therapy with HCVIDDOXIL alternating with high-dose methotrexate/ara-C in patients with newly diagnosed patients with peripheral T cell lymphoma (PTCL).

Secondary objectives include: response rate, overall survival, toxicity profile, and levels of serum and cell surface CD26 and associated molecules and their relationship to response to therapy.
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Study Status Information
Study Activation / Registration Date:09/17/2003
IRB Review and Approval Date:04/02/2003
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:N/A
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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) Confirmed diagnosis of previously untreated T-cell Non Hodgkin's Lymphomas and NK lymphomas, with the exception of CD30+ alk1+ T-anaplastic large cell lymphoma (ALCL). Patients with skin involvement alone are also excluded. For patients with skin involvement as part of systemic disease, prior topical treatment only is allowed.

2) Patients with a performance status of 3 or less (Zubrod Scale - see Appendix D).

3) Serum bilirubin </= 1.5 mg/dl and serum creatinine </= 2.0 mg/dl unless due to lymphoma; ANC >/= 1000 mm^3 and platelets >/= 100,000 mm^3 unless due to lymphoma.

4) Cardiac ejection fraction 50% or greater by MUGA or echocardiogram.

5) Ages 18 and older.

6) Patients must be willing to receive transfusions of blood products.
Exclusion Criteria:1) Patients with CD30+ alk1+ T-anaplastic large cell lymphoma (ALCL) or patients with skin involvement alone.

2) Pregnancy

3) HIV positive serology

4) CNS involvement

5) Co-morbid medical, such as Child's Class C liver cirrhosis, end-stage renal disease, and symptomatic congestive heart failure, or psychiatric illnesses that preclude treatment with intense dose chemotherapy as determined by the primary investigator

6) Concurrent or previous malignancy whose prognosis is poor (<90% probability of survival at 5 years)
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Links
Registration Number: NCT00290433
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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