Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003311

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.

Condition	Intervention	Phase
Lymphoma	Biological: filgrastim Drug: cyclophosphamide Drug: cytarabine Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: methotrexate Drug: vincristine sulfate	Phase II

Study Type:	Interventional
Study Design:	Treatment
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 Varients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Dexamethasone Cyclophosphamide Vincristine Methotrexate Cytarabine hydrochloride Doxorubicin Doxorubicin hydrochloride Dexamethasone acetate Doxiproct plus Myocet Filgrastim Cytarabine Dexamethasone Sodium Phosphate Vincristine sulfate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	45
Study Start Date:	March 1999

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

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003311

Locations

United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Jorge E. Romaguera, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000066258, MDA-DM-97200, NCI-T97-0101
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00003311 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Anti-Inflammatory Agents
Dexamethasone
Antimetabolites
Anti-Infective Agents
Immunologic Factors
Hormone Antagonists
Lymphoma, Mantle-Cell
Hormones, Hormone Substitutes, and Hormone Antagonists
Folate
Antiemetics
Mantle Cell Lymphoma
Cyclophosphamide
Hormones
Vitamin B9
Anti-Bacterial Agents

Methotrexate
Lymphoma
Alkylating Agents
Dexamethasone acetate
Cytarabine
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Vincristine
Antimitotic Agents
Folinic Acid
Folic Acid Antagonists
Immunosuppressive Agents
Antiviral Agents
Glucocorticoids
Doxorubicin

Additional relevant MeSH terms:

Dexamethasone
Anti-Inflammatory Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Lymphoma, Mantle-Cell
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Hormonal
Vincristine
Abortifacient Agents, Nonsteroidal
Glucocorticoids
Doxorubicin
Neoplasms
Lymphoma, Non-Hodgkin
Antineoplastic Agents, Phytogenic
Antimetabolites
Immunologic Factors
Antineoplastic Agents
Cyclophosphamide
Reproductive Control Agents

ClinicalTrials.gov processed this record on September 02, 2009