Pixantrone, Cytarabine, Methylprednisolone, and Cisplatin in Treating Patients With Aggressive Non-Hodgkin's Lymphoma in First Relapse

NCT00069966 | Unknown Phase 2

• 5 other identifiers: CDR0000316466THERADEX-AZA-II-02CWRU-NOVU-1403SUNY-HSC-4849NOVUSPHARMA-AZA-II-02
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 29

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as pixantrone, cytarabine, methylprednisolone, and cisplatin, work in 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 combination chemotherapy in treating patients who have relapsed aggressive non-Hodgkin's lymphoma.

Conditions

Lymphoma

Keywords

recurrent adult diffuse large cell lymphoma; anaplastic large cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent grade 3 follicular lymphoma; recurrent adult Burkitt lymphoma

Interventions

filgrastim BIOLOGICAL

rituximab BIOLOGICAL

cisplatin DRUG

cytarabine DRUG

methylprednisolone DRUG

pixantrone dimaleate DRUG

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 aggressive non-Hodgkin's lymphoma (NHL) * Any stage, with or without B symptoms * The following subtypes are eligible: * Diffuse large cell (B and T cell types) * Anaplastic large cell * Diffuse mixed cell * Immunoblastic large cell * Follicular large cell * Transformed follicular NHL * Diffuse aggressive not otherwise classified * Burkitt-like lymphoma * Bone marrow positive or negative * At least 1 measurable lesion * Patients with bone marrow as the only site of disease are eligible without a measurable lesion * No more than 1 episode of progressive disease, occurring after a response (complete response \[CR\], complete response unconfirmed \[CR\_u\], or partial response \[PR\]) to prior chemotherapy\* NOTE: \*Patients with less than a CR, CRu, or PR and no progression, but who are good candidates for high-dose chemotherapy with stem cell support may be eligible (will be decided on an individual basis) * No chemotherapy-refractory disease, defined as follows: * Stable or progressive disease documented at restaging immediately after the completion of induction therapy * No lymphoblastic lymphoma, or mantle cell lymphoma PATIENT CHARACTERISTICS: Age * 18 and over Performance status * WHO 0-1 Life expectancy * At least 3 months Hematopoietic * Neutrophil count at least 1,500/mm\^3\* * Platelet count at least 100,000/mm\^3\* NOTE: \*Lower values may be accepted if clearly due to bone marrow involvement by lymphoma Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN)\* * AST or ALT no greater than 2.0 times ULN\* * Alkaline phosphatase no greater than 2.0 times ULN\* * No history or clinical symptoms of hepatitis B or hepatitis C virus * Patients with seropositivity due to prior vaccination for hepatitis B are eligible NOTE: \*Higher values may be accepted if clearly due to liver involvement by lymphoma Renal * Creatinine no greater than 1.5 mg/dL Cardiovascular * LVEF at least 50% by MUGA * No clinically significant cardiovascular abnormalities * No New York Heart Association grade II-IV cardiovascular disease * No myocardial infarction within the past 6 months * No severe cardiac arrhythmia * No uncontrolled hypertension Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study participation * HIV negative * No clinically significant neurological abnormalities * No condition that would preclude study safety or interfere with study results * No concurrent serious uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy * Prior rituximab immediately after the first chemotherapy regimen allowed Chemotherapy * See Disease Characteristics * See Biologic therapy * At least 6 months since prior anthracycline therapy (e.g., cyclophosphamide, doxorubicin, vincristine, and prednisone \[CHOP\]) * More than 2 years since prior fludarabine * More than 2 years since prior nitrosoureas * More than 1 year since prior platinum-based chemotherapy or cytarabine, unless a CR or CR\_u was achieved * No prior cumulative dose of cisplatin greater than 600 mg/m\^2 * No prior single or cumulative dose of doxorubicin greater than 450 mg/m\^2 Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy to the whole pelvis * No prior radioimmunotherapy Surgery * More than 4 weeks since prior major thoracic and/or abdominal surgery * At least 1 week since prior minor surgery Other * Recovered from prior therapy * Alopecia allowed * Grade 1 peripheral neuropathy allowed * More than 30 days since prior participation in another investigational drug study * No other concurrent investigational drugs

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

Sponsors & Collaborators

• Theradex: lead

Study Sites (29)

Arizona Oncology Associates - Craycroft Road Offices

Tucson, Arizona, 85712-2254, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

Rocky Mountain Cancer Centers - Colorado Springs

Colorado Springs, Colorado, 80933-1181, United States

Location

Rocky Mountain Cancer Centers - Denver Midtown

Denver, Colorado, 80218, United States

Location

Delaware Clinical & Laboratory Physicians

Newark, Delaware, 19713, United States

Location

Pasco, Hernando Oncology Associates, P.A.

New Port Richey, Florida, 34652, United States

Location

Hematology-Oncology Associates of Illinois

Chicago, Illinois, 60611-2998, United States

Location

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536-0084, United States

Location

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, 71130-3932, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

UNMC Eppley Cancer Center at the University of Nebraska Medical Center

Omaha, Nebraska, 68198-7680, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Piedmont Hematology-Oncology Associates

Winston-Salem, North Carolina, 27103, United States

Location

Gabrail Cancer Center - Canton Office

Canton, Ohio, 44718, United States

Location

Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University

Cleveland, Ohio, 44106-5055, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Cancer Care Associates-West

Oklahoma City, Oklahoma, 73112-4414, United States

Location

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Cancer Centers of the Carolinas - Eastside

Greenville, South Carolina, 29615, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Fairfax Northern Virginia Hematology Oncology, P.C. - Fairfax

Fairfax, Virginia, 22031, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226-3596, United States

Location

Hospital Auxilio Mutuo

Hato Rey, 00918, Puerto Rico

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Anaplastic; Lymphoma, Non-Hodgkin; Lymphoma, Large-Cell, Immunoblastic; Lymphoma, Follicular; Burkitt Lymphoma

Interventions

Filgrastim; Rituximab; Cisplatin; Cytarabine; Methylprednisolone; 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, B-Cell; Lymphoma, T-Cell; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

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; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Julie M. Vose, MD

  University of Nebraska

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 3, 2003
• First Posted: October 7, 2003
• Study Start: April 1, 2003
• Last Updated: July 7, 2009

Record last verified: 2004-11

Locations

PR (1); US (28)