Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T-Cell Lymphoma - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	Ortho Biotech, Inc.
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00290433

Purpose

Objectives:

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.

Condition	Intervention	Phase
Lymphoma	Drug: Cyclophosphamide Drug: Mesna Drug: Vincristine Drug: Methotrexate Drug: Ara-C Drug: Dexamethasone Drug: G-CSF Drug: Doxil	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of the Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T Cell Lymphoma

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Time to Disease Progression [ Time Frame: Baseline and response assessments every 2 cycles (cycle is 21 days) ] [ Designated as safety issue: No ]

Estimated Enrollment:	55
Study Start Date:	September 2003
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: HCVIDDOXIL Regimen HCVIDDOXIL Regimen = Cyclophosphamide, Mesna, Doxil, Vincristine, Dexamethasone	Drug: Cyclophosphamide 300 mg/m^2 IV Over 3 Hours Twice Daily on Days 1, 2, and 3. Other Names: Cytoxan Neosar Drug: Mesna 600 mg/m^2 IV Continuous Infusion Over Days 1, 2, and 3. Drug: Vincristine 1.4 mg/m^2 IV On Day 4 and 11. Drug: Methotrexate 200 mg/m^2 IV Over 2 Hours on Day 1, followed by 800 mg/m^2 IV Over 22 Hours on Day 1. Drug: Ara-C 3 Gm/m^2 Over 2 Hours Twice Daily On Days 2 and 3. Other Names: Cytarabine Cytosar DepoCyt Cytosine arabinosine hydrochloride Drug: Dexamethasone 40 mg IV or by mouth daily on Days 1-4 and 11-14. Other Name: Decadron Drug: G-CSF 300 mcg subcutaneously 24 hours after end of Day 4 vincristine. Other Names: Filgrastim Neupogen Drug: Doxil 25 mg/m^2 IV Over 1 Hour on Day 2. Other Names: Pegylated Liposomal Doxorubicin Doxorubicin hydrochloride (lipsomal)

Arms

Assigned Interventions

Experimental: HCVIDDOXIL Regimen

HCVIDDOXIL Regimen = Cyclophosphamide, Mesna, Doxil, Vincristine, Dexamethasone

Drug: Cyclophosphamide

300 mg/m^2 IV Over 3 Hours Twice Daily on Days 1, 2, and 3.

Other Names:

Cytoxan
Neosar

Drug: Mesna

600 mg/m^2 IV Continuous Infusion Over Days 1, 2, and 3.

Drug: Vincristine

1.4 mg/m^2 IV On Day 4 and 11.

Drug: Methotrexate

200 mg/m^2 IV Over 2 Hours on Day 1, followed by 800 mg/m^2 IV Over 22 Hours on Day 1.

Drug: Ara-C

3 Gm/m^2 Over 2 Hours Twice Daily On Days 2 and 3.

Other Names:

Cytarabine
Cytosar
DepoCyt
Cytosine arabinosine hydrochloride

Drug: Dexamethasone

40 mg IV or by mouth daily on Days 1-4 and 11-14.

Other Name: Decadron

Drug: G-CSF

300 mcg subcutaneously 24 hours after end of Day 4 vincristine.

Other Names:

Filgrastim
Neupogen

Drug: Doxil

25 mg/m^2 IV Over 1 Hour on Day 2.

Other Names:

Pegylated Liposomal Doxorubicin
Doxorubicin hydrochloride (lipsomal)

Show Detailed Description

Eligibility

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

Criteria

Inclusion Criteria:

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.
Patients with a performance status of 3 or less (Zubrod Scale - see Appendix D).
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.
Cardiac ejection fraction 50% or greater by MUGA or echocardiogram.
Ages 18 and older.
Patients must be willing to receive transfusions of blood products.

Exclusion Criteria:

Patients with CD30+ alk1+ T-anaplastic large cell lymphoma (ALCL) or patients with skin involvement alone.
Pregnancy
HIV positive serology
CNS involvement
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
Concurrent or previous malignancy whose prognosis is poor (<90% probability of survival at 5 years)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290433

Locations

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Ortho Biotech, Inc.

Investigators

Principal Investigator:

Anas Younes, MD

UT MD Anderson Cancer Center

More Information

Additional Information:

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00290433 History of Changes
Other Study ID Numbers:	ID03-0004
Study First Received:	February 10, 2006
Last Updated:	October 21, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Lymphoma
Peripheral T Cell
HCVIDDOXIL Regimen
ARA-C
Cytosar
DepoCyt
Cytosine arabinosine hydrochloride
Pegylated Liposomal Doxorubicin
Doxorubicin hydrochloride
Doxil
Cyclophosphamide

Cytoxan
Neosar
Dexamethasone
Decadron
Mesna
Methotrexate
Vincristine
G-CSF
Filgrastim
Neupogen

Additional relevant MeSH terms:

Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Mesna
Cyclophosphamide
Cytarabine
Methotrexate
Dexamethasone

Doxorubicin
Vincristine
Lenograstim
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on February 09, 2012