Combination Chemotherapy, Bone Marrow or Peripheral Stem Cell Transplantation, and/or Biological Therapy in Treating Patients With Stage III or Stage IV Mantle Cell Lymphoma

NCT00004231 | Completed Phase 2 DMC

• 3 other identifiers: NU 96H3NU-96H3NCI-G99-1659
• Study Type: interventional
• Target: N/A
• 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 chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation and/or biological therapy in treating patients who have stage III, stage IV, or recurrent mantle cell lymphoma.

Conditions

Lymphoma

Keywords

stage III mantle cell lymphoma; stage IV mantle cell lymphoma; recurrent mantle cell lymphoma

Interventions

aldesleukin BIOLOGICAL

filgrastim BIOLOGICAL

recombinant interferon alfa BIOLOGICAL

busulfan DRUG

cyclophosphamide DRUG

cytarabine DRUG

doxorubicin hydrochloride DRUG

leucovorin calcium DRUG

methotrexate DRUG

prednisone DRUG

teniposide DRUG

vincristine sulfate DRUG

allogeneic bone marrow transplantation PROCEDURE

autologous bone marrow transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed stage III, IV, or recurrent mantle cell lymphoma * CD5 positive OR * Evidence of bcl-1 oncogene overexpression * Measurable or evaluable disease with at least one of the following: * Clear cut radiographic findings * Clearly defined bidimensional defect or mass at least 2 cm in diameter on radionuclide or CT scan * Enlarged spleen extending at least 2 cm below costal margin with lymphomatous involvement only * Enlarged liver with proof of lymphoma by biopsy * CNS involvement allowed * Fully HLA matched donor for allogeneic transplantation PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-3 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 3.0 mg/dL Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No significant cardiac disease Other: * No other prior malignancies except previously treated nonmelanoma skin cancer or carcinoma in situ of the cervix * No other medical problems that would preclude study * HIV negative * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * See Disease Characteristics * Prior chemotherapy, including doxorubicin, allowed Endocrine therapy: * See Disease Characteristics * Prior steroids allowed Radiotherapy: * See Disease Characteristics * Prior radiotherapy allowed excluding the indicator lesions Surgery: * Not specified

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

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Evens AM, Winter JN, Hou N, Nelson BP, Rademaker A, Patton D, Singhal S, Frankfurt O, Tallman MS, Rosen ST, Mehta J, Gordon LI. A phase II clinical trial of intensive chemotherapy followed by consolidative stem cell transplant: long-term follow-up in newly diagnosed mantle cell lymphoma. Br J Haematol. 2008 Feb;140(4):385-93. doi: 10.1111/j.1365-2141.2007.06908.x. Epub 2007 Dec 19.

  PMID: 18162124 RESULT

MeSH Terms

Conditions

Lymphoma; Lymphoma, Mantle-Cell

Interventions

aldesleukin; Filgrastim; Interferon-alpha; Busulfan; Cyclophosphamide; Cytarabine; Doxorubicin; Leucovorin; Methotrexate; Prednisone; Teniposide; Vincristine; Peripheral Blood Stem Cell Transplantation

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; Interferon Type I; Interferons; Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Aminopterin; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Glucosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Leo I. Gordon, MD

  Robert H. Lurie Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2000
• First Posted: January 27, 2003
• Study Start: October 1, 1999
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: June 6, 2012

Record last verified: 2012-05

Locations

US (1)