Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003311
• Other study ID #: CDR0000066258
• Secondary ID: MDA-DM-97200NCI-
• Status: Completed
• Phase: Phase 2
• Start date: May 20, 1998
• Est. completion date: April 18, 2007

Study information

• Verified date: November 2018
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 18, 2007
• Est. primary completion date: April 18, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell

Intervention

Biological:
• filgrastim

Drug:
• cyclophosphamide

• cytarabine

• dexamethasone

• doxorubicin hydrochloride

• methotrexate

• vincristine sulfate

Locations

Country	Name	City	State
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,