Clinical trial NCT00003311: Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
Official title: Phase II CCOP Trial of High Dose Methotrexate/ARA-C and HCVAD for Newly Diagnosed Nodular and Diffuse Mantle Cell Lymphoma and Their Blastic Variants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Keywords: stage I mantle cell lymphoma
contiguous stage II mantle cell lymphoma
noncontiguous stage II mantle cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-04-25
Enrollment: 19
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of different regimens of combination chemotherapy in treating patients with newly diagnosed mantle cell lymphoma.

Detailed description: OBJECTIVES:

* Evaluate the complete response rate and duration of response in patients with newly diagnosed diffuse or nodular mantle cell lymphoma or their blastic variant treated with high-dose methotrexate and cytarabine and high-dose cyclophosphamide, dexamethasone, doxorubicin, and vincristine (HCVAD).

OUTLINE: This is a multicenter study. Patients may receive either regimen A or both regimen A and regimen B, depending upon response.

* Regimen A: Patients receive methotrexate IV over 24 hours on day 1. Cytarabine is administered IV over 2 hours every 12 hours on days 2 and 3. Filgrastim (G-CSF) is administered subcutaneously (SC) daily beginning on day 4 and continuing until blood counts recover. Treatment repeats every 21 days for up to 8 courses.
* Regimen B: Patients receive cyclophosphamide IV over 3 hours every 12 hours on days 1-3. Doxorubicin is administered IV over 24 hours on days 4 and 5. Vincristine is administered IV over 30 minutes on days 4 and 11. Dexamethasone is administered orally or IV on days 1-4 and 11-14. G-CSF is administered SC beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for up to 7 courses.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within 4 years.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed previously untreated nodular or diffuse mantle cell lymphoma or their blastic variant
* No CNS involvement
* Not a candidate for stem cell transplantation or refuses one

PATIENT CHARACTERISTICS:

Age:

* 16 and over

Performance status:

* Zubrod 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count greater than 1,000/mm\^3\*
* Platelet count greater than 100,000/mm\^3\* NOTE: \* Unless lymphoma involvement

Hepatic:

* Bilirubin less than 1.5 mg/dL (unless lymphoma involvement)

Renal:

* Creatinine less than 2.0 mg/dL (unless lymphoma involvement)

Cardiovascular:

* Cardiac ejection fraction at least 50% (for patients over age 40)

Other:

* Must be willing to receive blood transfusion
* Not pregnant or nursing
* Fertile patients must use effective contraception
* HIV negative
* No other co-morbid medical or psychiatric illness that would preclude treatment
* No prior or concurrent malignancy with poor prognosis (less than 90% probability of survival at 5 years)

PRIOR CONCURRENT THERAPY:

Biologic therapy

* See Disease Characteristics

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas - MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jorge E. Romaguera, MD
role: STUDY_CHAIR
References: