Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T-Cell Lymphoma
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
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 22, 2013
Last verified: March 2013
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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:
Drug Information available for:
Dexamethasone
Cyclophosphamide
Methotrexate
Cytarabine
Dexamethasone acetate
Vincristine sulfate
Dexamethasone sodium phosphate
Methotrexate sodium
Mesna
Doxorubicin
Doxorubicin hydrochloride
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
U.S. FDA Resources
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 2014 |
| Estimated Primary Completion Date: | September 2014 (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:
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:
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:
Drug: Doxil
25 mg/m^2 IV Over 1 Hour on Day 2.
Other Names:
|
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 | |
| 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 |
| Study First Received: | February 10, 2006 |
| Last Updated: | March 22, 2013 |
| 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 May 23, 2013