Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma

NCT ID: NCT00003311

Last Updated: 2018-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-05-20
• Study Completion Date: 2007-04-18

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.

Conditions

Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Regimen A

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.

Group Type: EXPERIMENTAL

filgrastim

Intervention Type: BIOLOGICAL

cytarabine

Intervention Type: DRUG

methotrexate

Intervention Type: DRUG

Regimen B

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.

Group Type: EXPERIMENTAL

filgrastim

Intervention Type: BIOLOGICAL

cyclophosphamide

Intervention Type: DRUG

dexamethasone

Intervention Type: DRUG

doxorubicin hydrochloride

Intervention Type: DRUG

vincristine sulfate

Intervention Type: DRUG

Interventions

filgrastim

Intervention Type: BIOLOGICAL

cyclophosphamide

Intervention Type: DRUG

cytarabine

Intervention Type: DRUG

dexamethasone

Intervention Type: DRUG

doxorubicin hydrochloride

Intervention Type: DRUG

methotrexate

Intervention Type: DRUG

vincristine sulfate

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jorge E. Romaguera, MD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Locations

University of Texas - MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

MDA-DM-97200

Identifier Type: -

Identifier Source: secondary_id

NCI-T97-0101

Identifier Type: -

Identifier Source: secondary_id

DM97-200

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000066258

Identifier Type: -

Identifier Source: org_study_id