Expired Study
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Houston, Texas 77030


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00003311


Primary Contact:

Study Chair
Jorge E. Romaguera, MD
M.D. Anderson Cancer Center


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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