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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ortho Biotech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00290433
First received: February 10, 2006
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: Cyclophosphamide
Drug: Mesna
Drug: Vincristine
Drug: Methotrexate
Drug: Ara-C
Drug: Dexamethasone
Drug: G-CSF
Drug: Doxil
Phase 2

Study Type: Interventional
Study Design: 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 2015
Estimated Primary Completion Date: September 2015 (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)

  Show Detailed Description

  Eligibility

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

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290433

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Ortho Biotech, Inc.
Investigators
Principal Investigator: Yasuhiro Oki, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00290433     History of Changes
Other Study ID Numbers: ID03-0004, NCI-2010-00445
Study First Received: February 10, 2006
Last Updated: March 6, 2014
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 April 23, 2014