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A Phase II Study of DAB 389 IL-2, an Interleukin-2 Fusion Toxin, for Previously Treated Stage II, III, and IV Follicular Low-Grade Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A Phase II Study of DAB 389 IL-2, an Interleukin-2 Fusion Toxin, for Previously Treated Stage II, III, and IV Follicular Low-Grade Non-Hodgkin's Lymphoma


OBJECTIVES: I. Determine the objective response rate in patients with previously treated
stage I, II, III, or IV low- or intermediate-grade B-cell non-Hodgkin's lymphoma treated
with denileukin diftitox. II. Determine the time to progression, duration of remission, and
time to treatment failure in patients after treatment with this therapy. III. Determine the
toxicity of this therapy in these patients. IV. Correlate the results of the inteleukin-2
receptor assay with treatment outcomes in these patients.

OUTLINE: Patients are stratified according to interleukin-2 receptor classification
(positive vs negative). Patients receive immunotoxin therapy with denileukin diftitox IV
over 15-60 minutes on days 1-5. Treatment repeats every 21 days for 2-6 courses in the
absence of disease progression or unacceptable toxicity. Patients are followed every 3
months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 33 patients will be accrued for the interleukin-2 (IL-2)
receptor-positive stratum and a total of 11-44 patients will be accrued for the IL-2
receptor-negative stratum.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven stage I, II, III, or IV low- or
intermediate-grade B-cell non-Hodgkin's lymphoma Small lymphocytic Follicular small
cleaved cell Follicular mixed cell Follicular large cell Marginal Diffuse large B-cell
Lymphoplasmacytoid Patients with small lymphocytic lymphoma must have an absolute
lymphocyte count less than 10,000/mm3 At least one bidimensionally measurable site At
least 1.5 cm in its greatest dimension Not in field of prior radiotherapy Progressive
disease after at least one prior treatment regimen for lymphoma 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: See Disease Characteristics Absolute neutrophil count at
least 1000/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) ALT or AST no greater than
2 times ULN Albumin greater than 3.0 g/dL No hepatitis B or C infection Renal: Creatinine
no greater than ULN Other: Not pregnant or nursing Fertile patients must use effective
contraception HIV negative No active infection requiring anti-infective therapy No other
prior invasive malignancy within past 5 years, except: Curatively treated basal cell or
squamous cell skin cancer Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior stem cell transplantation allowed At
least 4 weeks since prior biologic therapy No other concurrent immunotherapy Chemotherapy:
At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At
least 4 weeks since prior endocrine therapy No concurrent hormonal therapy (except
contraceptives and replacement steroids) No concurrent corticosteroids Radiotherapy: See
Disease Characteristics At least 4 weeks since prior radiotherapy for localized disease No
concurrent radiotherapy Surgery: Not specified Other: No other concurrent experimental
medications (including approved drugs tested in an investigational setting)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Timothy M. Kuzel, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000066692

NCT ID:

NCT00003615

Start Date:

March 1999

Completion Date:

Related Keywords:

  • Lymphoma
  • Waldenstrom macroglobulinemia
  • stage I grade 1 follicular lymphoma
  • stage I grade 2 follicular lymphoma
  • stage I grade 3 follicular 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 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 large cell lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse large 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 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 large cell lymphoma
  • contiguous stage II marginal zone lymphoma
  • contiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Morristown Memorial HospitalMorristown, New Jersey  07962-1956
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Trinitas Hospital - Jersey Street CampusElizabeth, New Jersey  07201
Hunterdon Regional Cancer CenterFlemington, New Jersey  08822
Hackensack University Medical CenterHackensack, New Jersey  07601
Overlook HospitalSummit, New Jersey  07902-0220
Riverview Medical Center - Booker Cancer CenterRed Bank, New Jersey  07701