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Irinotecan in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma
This study has been completed.
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003245
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients with recurrent or refractory non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Drug: irinotecan hydrochloride
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Irinotecan for the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma

Resource links provided by NLM:


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

Study Start Date: February 1998
Detailed Description:

OBJECTIVES:

  • Determine the objective response rate and toxicity of irinotecan when administered to patients with recurrent or refractory non-Hodgkin's lymphoma.

OUTLINE: Patients are stratified by disease category (aggressive vs indolent vs mantle cell lymphoma). Patients with aggressive and indolent lymphoma are further stratified as to being refractory (no complete response (CR) or partial response (PR) to initial therapy) vs recurrent (CR or PR to initial therapy); i.e, the following subcategories are used:

  • Stratum I:Refractory aggressive non-Hodgkin's lymphoma (NHL)
  • Stratum II:Recurrent aggressive NHL
  • Stratum III: Refractory indolent NHL
  • Stratum IV: Recurrent indolent NHL
  • Stratum V: Mantle cell NHL All patients receive irinotecan intravenously every 21 days. Patients achieving CR or PR receive 6 courses. Patients may receive bone marrow transplantation after at least 2 courses.

Patients are followed every 3 months for survival.

PROJECTED ACCRUAL: This study will accrue 18 patients per stratum; if at least three patients respond, an additional 25 patients will be accrued for a total of 43 evaluable patients per stratum. The total number accrued will be 90-215 over a period of approximately 3 years.

  Eligibility

Ages Eligible for Study:   15 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed recurrent or refractory non-Hodgkin's lymphoma

    • First relapse requires histologic confirmation of relapse
  • No CNS metastases
  • No lymphomatous meningitis
  • Measurable disease

PATIENT CHARACTERISTICS:

Age:

  • 15-75

Performance status:

  • Zubrod 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Unless due to lymphoma:

    • Platelet count at least 100,000/mm^3
    • Absolute granulocyte count at least 1,500/mm^3
    • Hemoglobin at least 9 g/dL

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • SGOT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN if liver involvement)

Renal:

  • Creatinine no greater than 2.0 mg/dL
  • Baseline calcium less than 12 mg/dL

Cardiovascular:

  • No myocardial infarction within 6 months
  • No congestive heart failure requiring therapy

Other:

  • No history of seizures
  • No uncontrolled diabetes mellitus (i.e., random blood sugar of at least 250 mg)
  • No other concurrent severe disease
  • No uncontrolled infection
  • HIV negative
  • No psychoses
  • No prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cancer of the cervix unless surgically treated and disease free for at least 5 years
  • Not pregnant or lactating
  • Effective contraception required of fertile patients

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior bone marrow transplantation

Chemotherapy:

  • No more than 2 prior chemotherapy regimens for treatment of lymphoma
  • No prior irinotecan, topotecan or aminocamptothecin
  • At least 3 weeks since prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 3 weeks since prior radiotherapy
  • Radiotherapy that is not a part of a combined-modality therapy is counted as a regimen (see Chemotherapy)

Surgery:

  • Not specified

Other:

  • No phenytoin, phenobarbital, or other antiepileptic prophylaxis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003245

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Andre Goy, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000066124, MDA-DM-97182, NCI-T97-0103
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00003245     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
Waldenstrom macroglobulinemia
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult Burkitt lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Irinotecan
Enzyme Inhibitors
Pharmacologic Actions
Camptothecin
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 27, 2009