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A Multicenter Phase II Evaluation Of ONTAK (DENILEUKINDIFTITOX) In Patients With Low Or Intermediate Grade-B-Cell Non-Hodgkin's Lymphoma Who Have Been Treated Previously With A Monoclonal Antibody Or Who Are Not Candidates For Monoclonal Antibody Therapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Leukemia, Lymphoma

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Trial Information

A Multicenter Phase II Evaluation Of ONTAK (DENILEUKINDIFTITOX) In Patients With Low Or Intermediate Grade-B-Cell Non-Hodgkin's Lymphoma Who Have Been Treated Previously With A Monoclonal Antibody Or Who Are Not Candidates For Monoclonal Antibody Therapy


OBJECTIVES: I. Determine the efficacy of denileukin diftitox in patients with stages I-IV
low- or intermediate-grade B-cell non-Hodgkin's lymphoma. II. Determine the safety of this
drug in these patients.

OUTLINE: This is a multicenter study. Patients receive denileukin diftitox IV over 30-60
minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity. Patients may receive up to 2 additional courses after achieving
complete response. Patients are followed every 3 months until they have progressed or for 2
years from date of termination.

PROJECTED ACCRUAL: A total of 58 patients (29 with low-grade non-Hodgkin's lymphoma (NHL)
and 29 with intermediate-grade NHL) will be accrued for this study within 12 months. The
study may be stopped after accrual of 20 patients (10 with low-grade NHL and 10 with
intermediate-grade NHL) if observed response rate is less than 1 in 10 for each stratum.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed low-grade B-cell non-Hodgkin's lymphoma
(NHL) Working Formulation classification: Small lymphocytic lymphoma Follicular lymphoma
(small cleaved or mixed small and large cell) REAL classification: B-cell chronic
lymphocytic leukemia/small lymphocytic Lymphoplasmacytoid Marginal zone/MALT Follicular
small or mixed small and large cell OR Histologically confirmed intermediate-grade B-cell
NHL Working Formulation classification: Follicular large cell Diffuse small cleaved cell
Diffuse mixed small and large cell Diffuse large cell REAL classification: Mantle cell
Diffuse small cell Marginal zone/MALT Large B-cell Lymphoplasmacytoid Stage I, II, III, or
IV disease No cutaneous T-cell lymphoma or other T-cell NHL Bidimensionally measurable
disease Unidimensionally measurable disease allowed for mediastinal lymphoma only if
outside previously irradiated field or there is evidence of progression Received prior
monoclonal antibody therapy OR ineligible for monoclonal antibody therapy A new
classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The
terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of
"low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former
terminology.

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count
at least 50,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin no greater than 1.5
times upper limit of normal (ULN) AST and ALT no greater than 1.5 times ULN Albumin at
least 3.0 g/dL No chronic hepatitis Renal: Creatinine less than 1.8 mg/dL Cardiovascular:
No New York Heart Association class III or IV heart disease No poorly controlled
hypertension Other: Not pregnant or nursing Negative pregnancy test Fertile patients must
use effective contraception HIV negative No serious concurrent illness or active infection
requiring parenteral antibiotics that would preclude study No known hypersensitivity to
study drug or its components, including diphtheria toxin, interleukin-2, or excipients No
other malignancy within the past 5 years except resected basal or squamous cell skin
cancer or carcinoma in situ of the cervix (prostate cancer in situ or breast cancer in
situ within the past 5 years is allowed if patients are in complete remission with no
active disease, have stable tumor markers for at least 3 months, and have a life
expectancy of at least 2 years)

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Prior bone marrow
transplantation allowed No prior denileukin diftitox or DAB486 IL-2 No concurrent
immunotherapy Chemotherapy: No concurrent chemotherapy Endocrine therapy: No concurrent
hormonal anticancer therapy Radiotherapy: See Disease Characteristics At least 4 weeks
since prior radiotherapy No prior radiotherapy to sole site of disease unless evidence of
progression No concurrent radiotherapy Surgery: Not specified Other: At least 1 month
since prior investigational agent No other concurrent experimental medications, including
approved drugs tested in an investigational setting

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Debby Henkens

Investigator Role:

Study Chair

Investigator Affiliation:

Pharmatech Oncology

Authority:

United States: Federal Government

Study ID:

CDR0000069029

NCT ID:

NCT00026429

Start Date:

January 2001

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • refractory chronic lymphocytic leukemia
  • B-cell chronic lymphocytic leukemia
  • stage I grade 1 follicular lymphoma
  • stage I grade 2 follicular lymphoma
  • stage I grade 3 follicular lymphoma
  • stage I adult diffuse small cleaved cell lymphoma
  • stage I adult diffuse mixed cell lymphoma
  • stage I adult diffuse large cell lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • 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
  • stage I mantle cell lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • contiguous stage II adult diffuse small cleaved cell lymphoma
  • contiguous stage II mantle cell lymphoma
  • contiguous stage II adult diffuse mixed cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent mantle cell lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage I marginal zone lymphoma
  • stage I small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • contiguous stage II marginal zone lymphoma
  • contiguous stage II small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

Cancer and Blood Institute of the DesertRancho Mirage, California  92270
Boston Baskin Cancer Group, University Tennessee Oncology/Hematology GroupMemphis, Tennessee  38119
Missouri Cancer Care, P.C.St. Charles, Missouri  63301
Nassau Hematology/Oncology PCLake Success, New York  11042
ION/Pharmatech NetworkPomona, California  91767
Coastal Cancer CenterMyrtle Beach, South Carolina  29572