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Combination Chemotherapy Plus Rituximab in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma - Article


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Adult Non-Hodgkin's Lymphoma


Clinical Trial: Combination Chemotherapy Plus Rituximab in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma

This study is no longer recruiting patients.

Sponsored by: University of Nebraska
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy combined with rituximab in treating patients who have recurrent or refractorynon-Hodgkin's lymphoma.

Condition Treatment or Intervention Phase
adult non-Hodgkin's lymphoma
 Drug: carboplatin
 Drug: etoposide
 Drug: ifosfamide
 Drug: rituximab
 Procedure: antibody therapy
 Procedure: biological response modifier therapy
 Procedure: chemotherapy
 Procedure: monoclonal antibody therapy
Phase II

MedlinePlus related topics:  Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Ifosfamide, Carboplatin, Etoposide, and Rituximab in Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma

Further Study Details: 

OBJECTIVES:

OUTLINE: Patients receive rituximab IV on days 1, 8, and 15 and ifosfamide IV over 1 hour, etoposide IV over 2 hours, and carboplatin IV on days 2-4. Treatment continues every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients who are not candidates for autologous stem cell transplantation may receive 1-4 more courses of chemotherapy without rituximab.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 19-39 patients will be accrued for this study within 2 years.

Eligibility

Ages Eligible for Study:  19 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: Age:

  • 19 and over

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 70-100%

Life expectancy:

  • At least 3 months

Hematopoietic:

  • WBC at least 3,000/mm3
  • Granulocyte count at least 1,000/mm3
  • Platelet count at least 100,000/mm3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST or ALT no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than 1.5 mg/dL

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other prior malignancy except curatively treated basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix
  • No active serious infection
  • No other concurrent serious medical condition that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy:

Chemotherapy:

  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent corticosteroids except transient administration as antiemetic
  • Concurrent non-steroidal hormonal therapy allowed for non-disease related conditions (e.g., insulin for diabetes)

Radiotherapy:

  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • No other concurrent investigational therapy
  • No other concurrent antitumor agents

Location Information


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

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:  CDR0000068306; UNMC-032-00; NCI-V00-1635
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  January 6, 2001
ClinicalTrials.gov Identifier:  NCT00007865
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


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


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August 30, 2008



Page Updated: September 6, 2005
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