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A Phase II Study of the Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T Cell Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

A Phase II Study of the Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T Cell Lymphoma


All of the drugs used in this study are commonly used in the treatment of cancer. However,
using these drugs in combination is investigational.

During treatment, you will be given two different cycles of chemotherapy, which will be
alternated every 21 days.

For Cycle 1, cyclophosphamide will be given by vein two times a day on Days 1,2, and 3.
Each dose will take around 3 hours to give. Mesna will be given by vein nonstop over Days 1
through 3. Pegylated liposomal doxorubicin will be given by vein over 1 hour on Day 2.
Vincristine will be given by vein on Days 4 and 11. Dexamethasone will be given by mouth on
Days 1 through 4 and 11 through 14. Other drugs will be given before, during, and after
chemotherapy to help decrease the risk of developing side effects. These drugs may be given
by mouth or by injection.

For Cycle 2, methotrexate will be given by vein over 2 hours on Day 1 and over 22 hours on
day 1. Cytarabine will be given by vein twice a day on Days 2 and 3. Each dose will take
about 2 hours to give. Other drugs will be given before, during, and after treatment to
help decrease the risk of developing side effects. These drugs may be given by mouth or by
injection.

To help increase the blood counts and help decrease the risk of developing infections, your
doctor may decide that treatment with filgrastim is necessary. Filgrastim may be given as
once-a-day injections under the skin starting 24 hours after the end of Day 4 vincristine
(Cycle 1) and starting 24 hours after the end of Cytarabine (Cycle 2). Your blood counts
will be monitored and filgrastim is stopped when the levels become normal.

Cycles 1 and 2 will be alternated every 21 days. Both Cycles 1 and 2 can be given on an
outpatient basis if your physician authorizes it. However, if your serum creatinine (blood
test) reaches a certain level, Cycle 2 should be given on an inpatient basis.

Depending on how the disease responds, treatment may be stopped after 2,4, or 6 cycles.
However, treatment may continue for up to 8 cycles.

During treatment, you will have around 2-3 tablespoons of blood collected at least once a
week for routine tests.

After every 2 cycles, tumors will be measured using x-rays or other scans (CT, MRI, etc.)
and bone marrow samples will be taken. Heart scans or heart function tests may also be
needed if you doctor feels it is necessary.

If the disease gets worse or you experience any intolerable side effects, you will be taken
off the study and your doctor will discuss other treatment options with you.

After the last cycle of chemotherapy, you will have follow-up exams scheduled. During these
exams, you will have a chest x-ray and CT scans of the chest, abdomen (stomach) and pelvis
(waist area), and PET scan. You will have blood collected (2-3 tablespoons) for routine
tests. If your doctor feels it is necessary, you may also have a sample of bone marrow
collected. You may choose to have long-term follow-up exams at M. D. Anderson or with your
local physician.

This is an investigational study. All of the study drugs are approved by the FDA for cancer
treatment and are commercially available. However, the use of the drugs in combination is
experimental. Up to 55 participants will take part in this study. All will be enrolled at
UT MD Anderson Cancer Center.


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 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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Disease Progression

Outcome Time Frame:

Baseline and response assessments every 2 cycles (cycle is 21 days)

Safety Issue:

No

Principal Investigator

Yasuhiro Oki, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

ID03-0004

NCT ID:

NCT00290433

Start Date:

September 2003

Completion Date:

September 2014

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral

Name

Location

University of Texas MD Anderson Cancer CenterHouston, Texas  77030