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Phase II Trial With Correlative Laboratory Studies of Single Agent Irinotecan (Camptosar CPT-11) in Newly Diagnosed and Relapsed Indolent Lymphoproliferative Malignancies


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Lymphoma

Thank you

Trial Information

Phase II Trial With Correlative Laboratory Studies of Single Agent Irinotecan (Camptosar CPT-11) in Newly Diagnosed and Relapsed Indolent Lymphoproliferative Malignancies


OBJECTIVES: I. Determine the complete and partial response rates in patients with newly
diagnosed or relapsed indolent non-Hodgkin's lymphoma, high risk chronic lymphocytic
leukemia, or prolymphocytic leukemia treated with irinotecan. II. Determine the toxicity of
this regimen in these patients. III. Correlate the level of DNA topoisomerase I mRNA and
protein, as well as SN-38 induced topoisomerase I-DNA complex formation, with the clinical
response and toxicity in these patients. IV. Determine if a down regulation of topoisomerase
I or altered subcellular distribution of this enzyme is involved in the drug resistance to
irinotecan.

OUTLINE: Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Treatment
repeats every 6 weeks for 2-6 courses in the absence of disease progression or unacceptable
toxicity. Patients are followed for survival.

PROJECTED ACCRUAL: A total of 17-40 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven newly diagnosed or relapsed non-Hodgkin's
lymphoma (NHL) of 1 of the following types: Low grade (diffuse small lymphocytic/marginal
zone, grade I follicular small cleaved cell, or grade II follicular mixed cell) OR Mantle
cell OR Histologically proven newly diagnosed or relapsed stage III or IV chronic
lymphocytic leukemia (CLL) or prolymphocytic leukemia (PLL) At least 1 measurable disease
parameter Enlarged spleen extending at least 2 cm below the costal margin constitutes
measurable disease provided that no explanation other than lymphomatous involvement is
likely Enlarged liver extending at least 5 cm below the costal margin constitutes
measurable disease Not allowable as sole indication for therapy: Isolated splenomegaly OR
Isolated hepatomegaly No central nervous system (CNS) metastases or carcinomatous
meningitis 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: Eastern Cooperative Oncology
Group (ECOG) 0-2 Life expectancy: At least 12 weeks Hematopoietic: NHL: Granulocyte count
greater than 1,500/mm^3 Hemoglobin at least 9.0 g/dL Platelet count greater than
100,000/mm^3 CLL or PLL: Granulocyte count greater than 500/mm^3 Hemoglobin greater than
7.0 g/dL Platelet count greater than 50,000/mm^3 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 tumor present) No Gilbert's disease Renal: Creatinine no greater than 2.0
mg/dL OR Creatinine clearance at least 60 mL/min Calcium less than 12.0 mg/dL (corrected)
Cardiovascular: No myocardial infarction or atrial fibrillation within the past 6 months
No congestive heart failure requiring therapy Other: No active or uncontrolled infection
HIV negative No psychiatric disorder that would preclude informed consent or compliance No
other malignancy within the past 5 years except basal cell or squamous cell skin cancer or
carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile
patients must use effective contraception No history of seizures No uncontrolled diabetes
mellitus, defined as random blood glucose at least 200 mg/dL No other severe concurrent
disease that would increase risk

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
irinotecan or any other topoisomerase I inhibitor (e.g., topotecan) Endocrine therapy: Not
specified Radiotherapy: Not specified Surgery: Not specified Other: No concurrent
phenytoin, phenobarbital, or other antiepileptic prophylaxis

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate (ORR)

Outcome Description:

Objective Response Rate according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Determine the complete and partial response rates in patients with newly diagnosed or relapsed indolent non-Hodgkin's lymphoma, high risk chronic lymphocytic leukemia, or prolymphocytic leukemia treated with irinotecan.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Steven C. Goldstein, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Federal Government

Study ID:

MCC-11586

NCT ID:

NCT00005626

Start Date:

February 1998

Completion Date:

November 2003

Related Keywords:

  • Leukemia
  • Lymphoma
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • refractory chronic lymphocytic leukemia
  • stage I grade 1 follicular lymphoma
  • stage I grade 2 follicular lymphoma
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • prolymphocytic leukemia
  • stage I mantle cell lymphoma
  • contiguous stage II grade 1 follicular lymphoma
  • contiguous stage II grade 2 follicular lymphoma
  • contiguous stage II mantle cell lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • noncontiguous stage II mantle 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
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Leukemia
  • Lymphoma

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612