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PHASE II TRIAL OF FLUDARABINE AND SANDOSTATIN FOR RELAPSED LOW-GRADE NON-HODGKIN'S LYMPHOMA


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

Thank you

Trial Information

PHASE II TRIAL OF FLUDARABINE AND SANDOSTATIN FOR RELAPSED LOW-GRADE NON-HODGKIN'S LYMPHOMA


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.

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.

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

Inclusion 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

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

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Thomas E. Witzig, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000064787

NCT ID:

NCT00002779

Start Date:

February 1998

Completion Date:

Related Keywords:

  • Lymphoma
  • Waldenström macroglobulinemia
  • recurrent small lymphocytic lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - OchsnerNew Orleans, Louisiana  70121
Quain & Ramstad Clinic, P.C.Bismarck, North Dakota  58501
CCOP - Merit Care HospitalFargo, North Dakota  58122
Altru Health SystemsGrand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
CCOP - Geisinger Clinical and Medical CenterDanville, Pennsylvania  17822-2001
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080