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

This study is no longer recruiting patients.

Sponsored by: Theradex
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
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's lymphoma
 Drug: cisplatin
 Drug: cytarabine
 Drug: filgrastim
 Drug: methylprednisolone
 Drug: pixantrone
 Drug: rituximab
 Procedure: antibody therapy
 Procedure: autologous bone marrow transplantation
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: bone marrow transplantation
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: monoclonal antibody therapy
 Procedure: peripheral blood stem cell transplantation
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lymphatic Diseases;   Lymphoma;   Viral Infections

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Pixantrone, Cytarabine, Methylprednisolone, and Cisplatin in Patients With Aggressive Non-Hodgkin's Lymphoma in First Relapse

Further Study Details: 

OBJECTIVES:

OUTLINE: This is an open-label, multicenter study.

  • Patients receive pixantrone IV over 1 hour on day 1; cisplatin IV over 30 minutes on days 1-4; methylprednisolone IV over 15-30 minutes on days 1-5; and cytarabine IV over 2 hours on day 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After 2 courses of salvage therapy, patients are re-evaluated and treated as follows:
  • Complete response (CR) or partial response (PR): Patients with a CR or PR who are suitable candidates for autologous stem cell transplantation (ASCT) proceed to mobilization therapy, high-dose chemotherapy, and ASCT. Patients with a CR or PR who are unsuitable candidates for ASCT continue to receive salvage therapy for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  • Stable disease: Patients with stable disease continue to receive salvage therapy for up to 6 courses. Patients who have a CR or PR after 3-4 courses of salvage therapy and who are suitable candidates for ASCT proceed to mobilization therapy, high-dose chemotherapy, and ASCT off study at the investigator’s discretion.
  • Patients receive rituximab* IV on days 1 and 7; pixantrone IV over 1 hour on day 2; cisplatin IV over 30 minutes on days 2-5; cytarabine IV over 2 hours on day 6; and methylprednisolone IV over 15-30 minutes on days 2-6. Patients also receive filgrastim (G-CSF) subcutaneously once daily beginning on day 7 and continuing until blood counts recover. Patients receive 1 or more courses of mobilization therapy during which stem cells are harvested. Patients then proceed to high-dose chemotherapy and subsequent re-infusion of harvested stem cells. NOTE: *If this mobilization regimen is used, patients with T-cell lymphoma do not receive rituximab
  • High-dose chemotherapy and ASCT: Patients receive high-dose chemotherapy and ASCT per institutional standard practice. Patients are followed every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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
  • ], 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

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


Location Information


Arizona
      Arizona Oncology Associates - Craycroft Road Offices, Tucson,  Arizona,  85712-2254,  United States

California
      City of Hope Comprehensive Cancer Center, Duarte,  California,  91010-3000,  United States

      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90033-0804,  United States

Colorado
      Rocky Mountain Cancer Centers - Colorado Springs, Colorado Springs,  Colorado,  80933-1181,  United States

      Rocky Mountain Cancer Centers - Denver Midtown, Denver,  Colorado,  80218,  United States

Delaware
      Delaware Clinical & Laboratory Physicians, Newark,  Delaware,  19713,  United States

Florida
      Pasco, Hernando Oncology Associates, P.A., New Port Richey,  Florida,  34652,  United States

Illinois
      Hematology-Oncology Associates of Illinois, Chicago,  Illinois,  60611-2998,  United States

Kentucky
      Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington,  Kentucky,  40536-0084,  United States

Louisiana
      Louisiana State University Health Sciences Center - Shreveport, Shreveport,  Louisiana,  71130-3932,  United States

Massachusetts
      Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States

      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States

Nebraska
      UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha,  Nebraska,  68198-7680,  United States

New York
      North Shore University Hospital, Manhasset,  New York,  11030,  United States

      SUNY Upstate Medical University Hospital, Syracuse,  New York,  13210,  United States

North Carolina
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States

      Piedmont Hematology-Oncology Associates, Winston Salem,  North Carolina,  27103,  United States

Ohio
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States

      Gabrail Cancer Center - Canton Office, Canton,  Ohio,  44718,  United States

      Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland,  Ohio,  44106-5055,  United States

Oklahoma
      Cancer Care Associates-West, Oklahoma City,  Oklahoma,  73112-4414,  United States

Oregon
      Providence Cancer Center at Providence Portland Medical Center, Portland,  Oregon,  97213,  United States

Pennsylvania
      Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033-0850,  United States

South Carolina
      Cancer Centers of the Carolinas - Eastside, Greenville,  South Carolina,  29615,  United States

Texas
      Baylor University Medical Center, Dallas,  Texas,  75246,  United States

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

Virginia
      Fairfax Northern Virginia Hematology Oncology, P.C. - Fairfax, Fairfax,  Virginia,  22031,  United States

Wisconsin
      Medical College of Wisconsin Cancer Center, Milwaukee,  Wisconsin,  53226-3596,  United States

Puerto Rico
      Hospital Auxilio Mutuo, Hato Rey,  00918,  Puerto Rico

Study chairs or principal investigators

Julie M. Vose, MD,  Study Chair,  University of Nebraska   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000316466; THERADEX-AZA-II-02; CWRU-NOVU-1403; SUNY-HSC-4849; NOVUSPHARMA-AZA-II-02; NCT00069966
Record last reviewed:  January 2005
Last Updated:  January 7, 2005
Record first received:  October 3, 2003
ClinicalTrials.gov Identifier:  NCT00069966
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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