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Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

Primary Purpose

Lymphoma

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
cisplatin
cytarabine
methylprednisolone
pixantrone dimaleate
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, recurrent grade 3 follicular lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent adult immunoblastic large cell lymphoma

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) including the following: Diffuse large B-cell lymphoma Transformed NHL Follicular large cell lymphoma Peripheral T-cell lymphoma Unclassified aggressive histology (immunoblastic lymphoma) Must have received 1 to 3 prior chemotherapy treatment regimens (may include doxorubicin up to a cumulative dose of no greater than 450 mg/m^2) No Burkitt's lymphoma, lymphoblastic lymphoma, or mantle cell lymphoma PATIENT CHARACTERISTICS: Age 18 to 64 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 evidence of bone marrow involvement Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN)** Alkaline phosphatase no greater than 2 times ULN** AST or ALT no greater than 2 times ULN** No history or clinical symptoms of hepatitis B or C virus NOTE: **Higher values may be accepted if evidence of liver involvement 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 class II-IV heart disease No myocardial infarction within the past 6 months No severe arrhythmia No uncontrolled hypertension Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 6 months after study No history or clinical symptoms of HIV No clinically significant neurological abnormalities No serious uncontrolled infection (NCI CTC grade 3-4) No condition that would place the patient at undue risk or interfere with the study results PRIOR CONCURRENT THERAPY: Biologic therapy At least 3 months since prior radioimmunotherapy Chemotherapy See Disease Characteristics At least 4 weeks since prior chemotherapy At least 1 year since prior platinum or cytarabine (unless complete response to treatment) At least 2 years since prior fludarabine or nitrosoureas No prior cumulative cisplatin greater than 600 mg/m^2 Endocrine therapy Not specified Radiotherapy See Biologic therapy At least 4 weeks since prior radiotherapy No prior radiotherapy to the whole pelvis Surgery At least 1 week since prior minor surgery and recovered At least 4 weeks since prior major thoracic and/or abdominal surgery and recovered Other At least 1 month since prior investigational drugs Recovered from prior therapy No other concurrent investigational drugs

Sites / Locations

  • Arizona Clinical Research Center
  • Highlands Oncology Group
  • USC/Norris Comprehensive Cancer Center and Hospital
  • Marlene and Stewart Greenebaum Cancer Center, University of Maryland
  • Ireland Cancer Center
  • Boston Baskin Cancer Group, University Tennessee
  • University of Texas - MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 27, 2003
Last Updated
July 4, 2009
Sponsor
Theradex
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1. Study Identification

Unique Protocol Identification Number
NCT00053105
Brief Title
Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
Official Title
A Phase I Trial of BBR 2778 in Combination With Cytarabine, Methylprednisolone and Cisplatin in the Treatment of Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2003
Overall Recruitment Status
Unknown status
Study Start Date
February 2002 (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 use 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 I trial to study the effect of combination chemotherapy on the body when treating patients who have relapsed or refractory aggressive non-Hodgkin's lymphoma.
Detailed Description
OBJECTIVES: Determine the maximum tolerated dose and recommended dose of pixantrone when administered with cytarabine, methylprednisolone, and cisplatin in patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. Determine the dose-limiting toxic effects of this regimen in these patients. Determine the relationship between toxicity and systemic exposure to this regimen in these patients. Determine the safety of this regimen in these patients. Assess the pharmacokinetics of this regimen in these patients. Determine, preliminarily, the efficacy of this regimen in these patients. OUTLINE: This is an open-label, non-randomized, multicenter, dose-escalation study of pixantrone. Patients receive pixantrone IV over 1 hour on day 1, methylprednisolone IV over 15 minutes on days 1-5, cisplatin IV over 30 minutes on days 1-4, and cytarabine IV over 2 hours on day 5. Treatment repeats every 21 days for at least 8 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of pixantrone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the recommended dose, which is defined as the dose preceding the MTD. Patients are followed every 3 months. PROJECTED ACCRUAL: Approximately 3-30 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, recurrent grade 3 follicular lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent adult immunoblastic large cell lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) including the following: Diffuse large B-cell lymphoma Transformed NHL Follicular large cell lymphoma Peripheral T-cell lymphoma Unclassified aggressive histology (immunoblastic lymphoma) Must have received 1 to 3 prior chemotherapy treatment regimens (may include doxorubicin up to a cumulative dose of no greater than 450 mg/m^2) No Burkitt's lymphoma, lymphoblastic lymphoma, or mantle cell lymphoma PATIENT CHARACTERISTICS: Age 18 to 64 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 evidence of bone marrow involvement Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN)** Alkaline phosphatase no greater than 2 times ULN** AST or ALT no greater than 2 times ULN** No history or clinical symptoms of hepatitis B or C virus NOTE: **Higher values may be accepted if evidence of liver involvement 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 class II-IV heart disease No myocardial infarction within the past 6 months No severe arrhythmia No uncontrolled hypertension Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 6 months after study No history or clinical symptoms of HIV No clinically significant neurological abnormalities No serious uncontrolled infection (NCI CTC grade 3-4) No condition that would place the patient at undue risk or interfere with the study results PRIOR CONCURRENT THERAPY: Biologic therapy At least 3 months since prior radioimmunotherapy Chemotherapy See Disease Characteristics At least 4 weeks since prior chemotherapy At least 1 year since prior platinum or cytarabine (unless complete response to treatment) At least 2 years since prior fludarabine or nitrosoureas No prior cumulative cisplatin greater than 600 mg/m^2 Endocrine therapy Not specified Radiotherapy See Biologic therapy At least 4 weeks since prior radiotherapy No prior radiotherapy to the whole pelvis Surgery At least 1 week since prior minor surgery and recovered At least 4 weeks since prior major thoracic and/or abdominal surgery and recovered Other At least 1 month since prior investigational drugs Recovered from prior therapy No other concurrent investigational drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Fayad, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Highlands Oncology Group
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72764
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0800
Country
United States
Facility Name
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5055
Country
United States
Facility Name
Boston Baskin Cancer Group, University Tennessee
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

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