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

Primary Purpose

Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
filgrastim
rituximab
cisplatin
cytarabine
methylprednisolone
pixantrone dimaleate
autologous bone marrow transplantation
peripheral blood stem cell transplantation
Sponsored by
Theradex
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Oncology Associates - Craycroft Road Offices
  • City of Hope Comprehensive Cancer Center
  • USC/Norris Comprehensive Cancer Center and Hospital
  • Rocky Mountain Cancer Centers - Colorado Springs
  • Rocky Mountain Cancer Centers - Denver Midtown
  • Delaware Clinical & Laboratory Physicians
  • Pasco, Hernando Oncology Associates, P.A.
  • Hematology-Oncology Associates of Illinois
  • Markey Cancer Center at University of Kentucky Chandler Medical Center
  • Louisiana State University Health Sciences Center - Shreveport
  • Massachusetts General Hospital Cancer Center
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
  • North Shore University Hospital
  • SUNY Upstate Medical University Hospital
  • Duke Comprehensive Cancer Center
  • Piedmont Hematology-Oncology Associates
  • Gabrail Cancer Center - Canton Office
  • Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
  • Cleveland Clinic Taussig Cancer Center
  • Cancer Care Associates-West
  • Providence Cancer Center at Providence Portland Medical Center
  • Penn State Cancer Institute at Milton S. Hershey Medical Center
  • Cancer Centers of the Carolinas - Eastside
  • Baylor University Medical Center
  • University of Texas - MD Anderson Cancer Center
  • Fairfax Northern Virginia Hematology Oncology, P.C. - Fairfax
  • Medical College of Wisconsin Cancer Center
  • Hospital Auxilio Mutuo

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 3, 2003
Last Updated
July 4, 2009
Sponsor
Theradex
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1. Study Identification

Unique Protocol Identification Number
NCT00069966
Brief Title
Pixantrone, Cytarabine, Methylprednisolone, and Cisplatin in Treating Patients With Aggressive Non-Hodgkin's Lymphoma in First Relapse
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2004
Overall Recruitment Status
Unknown status
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Theradex

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Biological
Intervention Name(s)
rituximab
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Intervention Type
Drug
Intervention Name(s)
pixantrone dimaleate
Intervention Type
Procedure
Intervention Name(s)
autologous bone marrow transplantation
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie M. Vose, MD
Organizational Affiliation
University of Nebraska
Official's Role
Study Chair
Facility Information:
Facility Name
Arizona Oncology Associates - Craycroft Road Offices
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712-2254
Country
United States
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Colorado Springs
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80933-1181
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Denver Midtown
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Delaware Clinical & Laboratory Physicians
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Pasco, Hernando Oncology Associates, P.A.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Hematology-Oncology Associates of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2998
Country
United States
Facility Name
Markey Cancer Center at University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0084
Country
United States
Facility Name
Louisiana State University Health Sciences Center - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Piedmont Hematology-Oncology Associates
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Gabrail Cancer Center - Canton Office
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5055
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Cancer Care Associates-West
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112-4414
Country
United States
Facility Name
Providence Cancer Center at Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Cancer Centers of the Carolinas - Eastside
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Fairfax Northern Virginia Hematology Oncology, P.C. - Fairfax
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3596
Country
United States
Facility Name
Hospital Auxilio Mutuo
City
Hato Rey
ZIP/Postal Code
00918
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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