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

Sponsors and Collaborators:	M.D. Anderson Cancer Center Ortho Biotech, Inc.
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00290433

Purpose

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

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Mesna Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Filgrastim Cytarabine Cytarabine hydrochloride Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Methotrexate Vincristine sulfate Vincristine Granulocyte colony-stimulating factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of the Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T Cell Lymphoma

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

Primary Outcome Measures:

To learn if treatment with two types of chemotherapy combinations can help to control peripheral T-cell lymphoma. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	September 2003
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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. 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. Drug: Dexamethasone 40 mg IV or PO Daily On Days 1-4 and 11-14. Drug: G-CSF 300 mcg subcutaneously 24 hours after end of day 4 vincristine. Drug: Doxil 25 mg/m^2 IV Over 1 Hour on Day 2.

Arms

Assigned Interventions

1: Experimental

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.

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.

Drug: Dexamethasone

40 mg IV or PO Daily On Days 1-4 and 11-14.

Drug: G-CSF

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

Drug: Doxil

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

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

Contacts

Contact: Barbara Pro, MD

713-792-2860

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Barbara Pro, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Ortho Biotech, Inc.

Investigators

Principal Investigator:

Barbara Pro, MD

U.T.M.D. Anderson Cancer Center

More Information

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

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Barbara Pro, MD/Associate Professor )
Study ID Numbers:	ID03-0004
Study First Received:	February 10, 2006
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00290433
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Lymphoma
Peripheral T Cell
HCVIDDOXIL Regimen
ARA-C
Pegylated Liposomal Doxorubicin
Cyclophosphamide

Dexamethasone
Doxil
Mesna
Methotrexate
Vincristine

Study placed in the following topic categories:

Dexamethasone
Immunoproliferative Disorders
Vincristine
Cyclophosphamide
Lymphoma, T-Cell, Peripheral
Doxorubicin
Folic Acid
Lymphatic Diseases
Lymphoma, T-Cell

Methotrexate
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Mesna
Lymphoma
Peripheral T-cell lymphoma
Cytarabine
Dexamethasone acetate

Additional relevant MeSH terms:

Antimetabolites
Anti-Inflammatory Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Reproductive Control Agents
Antibiotics, Antineoplastic
Hormones
Therapeutic Uses
Abortifacient Agents
Dermatologic Agents

Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents, Hormonal
Mitosis Modulators
Gastrointestinal Agents
Enzyme Inhibitors
Antimitotic Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Glucocorticoids
Pharmacologic Actions
Neoplasms

ClinicalTrials.gov processed this record on January 16, 2009