Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma

NCT00003311 | Completed Phase 2

• 4 other identifiers: CDR0000066258MDA-DM-97200NCI-T97-0101DM97-200
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

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

Study Arms (2)

Regimen A

EXPERIMENTAL

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.

Biological: filgrastim; Drug: cytarabine; Drug: methotrexate

Regimen B

EXPERIMENTAL

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.

Biological: filgrastim; Drug: cyclophosphamide; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: vincristine sulfate

Interventions

filgrastim BIOLOGICAL

Regimen A; Regimen B

cyclophosphamide DRUG

Regimen B

cytarabine DRUG

Regimen A

dexamethasone DRUG

Regimen B

doxorubicin hydrochloride DRUG

Regimen B

methotrexate DRUG

Regimen A

vincristine sulfate DRUG

Regimen B

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Mantle-Cell

Interventions

Filgrastim; Cyclophosphamide; Cytarabine; Dexamethasone; Doxorubicin; Methotrexate; Vincristine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Aminoglycosides; Glycosides; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines

Study Officials

• Jorge E. Romaguera, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: April 25, 2003
• Study Start: May 20, 1998
• Primary Completion: April 18, 2007
• Study Completion: April 18, 2007
• Last Updated: November 14, 2018

Record last verified: 2018-11

Locations

US (1)