Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Fludarabine Plus Octreotide in Treating Patients With Relapsed Low-Grade Non-Hodgkin's Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	NCCTG-947851 NCT00002779, NCCTG-94-78-51

Objectives

I.  Determine the response rate and duration of response to fludarabine 
combined with octreotide and to octreotide alone in patients with relapsed 
indolent non-Hodgkin's lymphoma.

II.  Determine serum insulin-like growth factor-1 (IGF-1) and IGF-1 binding 
protein levels before and after treatment in this patient population.

III.  Determine somatostatin receptor subtypes in lymphoma biopsy samples from 
selected patients.

Entry Criteria

Disease Characteristics:

Histologically diagnosed indolent non-Hodgkin's lymphoma (NHL) of 1 of the
following types:
 Diffuse small lymphocytic cell
 Follicular small cleaved cell
 Follicular mixed small and large cleaved cell
 Mantle cell lymphoma/leukemia (intermediate differentiated lymphoma)
  Preferentially treated on protocol NCCTG-958053 when available
 Monocytoid B-cell
 Mucosa-associated lymphoid tissue (MALT)
 Lymphoplasmacytic lymphoma (Waldenstrom's macroglobulinemia)

Histology documented by lymph node (or other mass) or bone marrow biopsy
within 6 months prior to entry

Relapsed after cytotoxic chemotherapy regimens

At least 1 measurable lesion by palpation, chest x-ray, CT, or MRI, e.g.:
 Lymph node at least 1.5 x 1.5 cm by palpation
 Spleen at least 3 cm below left costal margin

The following exclude:
 CNS involvement by positive CSF cytology or CT/MRI
 B- or T-cell chronic lymphocytic leukemia
 Hairy cell leukemia
 Mycosis fungoides
 Aggressive lymphoma

Prior/Concurrent Therapy:

Recovered from toxic effects of prior therapy

Biologic therapy:
 See Disease Characteristics
 No concurrent interferon

Chemotherapy:
 See Disease Characteristics
 No prior purine nucleoside analogues (e.g., fludarabine, pentostatin, or 2-
  chlorodeoxyadenosine)
 At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas)
 No other concurrent cytotoxic chemotherapy

Endocrine therapy:
 No prior octreotide for lymphoma
 No concurrent corticosteriods except for Addison's disease

Radiotherapy:
 Not specified

Surgery:
 Not specified

Other:
 No other concurrent investigational drugs

Patient Characteristics:

Age:
 18 and over

Performance status:
 ECOG 0-2

Hematopoietic:
 Absolute neutrophil count at least 1,500/mm3
 Platelet count at least 100,000/mm3

Hepatic:
 Total bilirubin no greater than 2 times normal OR
 Direct bilirubin no greater than 1.0 mg/dL above normal

Renal:
 Creatinine no greater than 2.0 times normal

Cardiovascular:
 No uncontrolled congestive heart failure
 No uncontrolled hypertension
 No uncontrolled angina pectoris

Other:
 No uncontrolled or active infection
 No AIDS or HIV antibody
 No second malignancy within 5 years except:
  Carcinoma in situ of the cervix
  Resected nonmelanomatous skin cancer 
  Prostate cancer in remission following radical retropubic prostatectomy
   or radiotherapy
 Not pregnant or nursing
 Negative pregnancy test
 Fertile patients must use effective contraception

Expected Enrollment

A total of 23-34 patients will be accrued for this study within 1.5 years.

Outline

Patients receive fludarabine IV over 10-30 minutes on days 1-5. Patients not 
currently receiving octreotide, receive a test dose of octreotide 
subcutaneously on day 1 during course 1 only and then receive octreotide 
intramuscularly monthly on day 1. Treatment repeats every 28 days for 4-6 
courses.  Patients then receive octreotide alone for 6-8 courses.  Some 
patients may then receive another 12 courses of octreotide alone, for a total 
of 2 years of treatment.

Patients are followed every 3 months for 5 years or until disease progression.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Thomas Witzig, MD, Protocol chair		Ph: 507-266-9276 Email: witzig.thomas@mayo.edu

Registry Information
Official Title		PHASE II TRIAL OF FLUDARABINE AND SANDOSTATIN FOR RELAPSED LOW-GRADE NON-HODGKIN'S LYMPHOMA
Trial Start Date		1998-02-20
Registered in ClinicalTrials.gov		NCT00002779
Date Submitted to PDQ		1996-06-07
Information Last Verified		2000-07-01
NCI Grant/Contract Number		U10-CA25224