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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00069966
First received: October 3, 2003
Last updated: July 4, 2009
Last verified: November 2004
  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 Intervention Phase
Lymphoma
Biological: filgrastim
Biological: rituximab
Drug: cisplatin
Drug: cytarabine
Drug: methylprednisolone
Drug: pixantrone dimaleate
Procedure: autologous bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of BBR 2778 in Combination With Cytarabine, Methylprednisolone and Cisplatin (BSHAP) as Salvage in Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma

Resource links provided by NLM:


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

Study Start Date: April 2003
Detailed Description:

OBJECTIVES:

  • Determine the antitumor activity of pixantrone, cytarabine, methylprednisolone, and cisplatin in patients with aggressive non-Hodgkin's lymphoma in first relapse.
  • Determine the safety and tolerability of this regimen in these patients.
  • Determine the validity and safety of this regimen as a mobilization regimen before high-dose chemotherapy with stem cell support in these patients.

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

  • Salvage therapy: 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.

    • Mobilization therapy (optional regimen; regimen used for mobilization is 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 older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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_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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069966

  Show 29 Study Locations
Sponsors and Collaborators
Theradex
Investigators
Study Chair: Julie M. Vose, MD University of Nebraska
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00069966     History of Changes
Other Study ID Numbers: CDR0000316466, THERADEX-AZA-II-02, CWRU-NOVU-1403, SUNY-HSC-4849, NOVUSPHARMA-AZA-II-02
Study First Received: October 3, 2003
Last Updated: July 4, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cisplatin
Cytarabine
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Pixantrone
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antiviral Agents
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents

ClinicalTrials.gov processed this record on November 20, 2014