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

Alternate Title

Octreotide in Patients With Relapsed Hodgkin's Disease or Cutaneous T-cell Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and older	NCI	NCCTG-898251 MAYO-898251, NCCTG-89-82-51

Objectives

I.  Evaluate the activity of the somatostatin analogue octreotide in patients 
with measurable or evaluable Hodgkin's disease and cutaneous T-cell lymphoma.

II.  Determine patient tolerance to and response rate from high-dose 
octreotide (6 mg every 24 hours) administered subcutaneously by continuous 
infusion.

Entry Criteria

Disease Characteristics:

Cutaneous T-cell lymphoma following suboptimal response to
therapy (topical therapy, phototherapy, photopheresis,
cytotoxic therapy), including:
  Mycosis fungoides
  Sezary syndrome

Hodgkin's disease following suboptimal response to chemotherapy
and/or radiotherapy and for which no treatment with curative
intent is available

Measurable or evaluable disease required
  Measurable disease defined as:
     Bidimensionally measurable lymphadenopathy or cutaneous
     tumor by palpation or on chest x-ray, CT, or MRI

     Splenomegaly at least 3 cm below the left costal margin on
     quiet respiration

     Hepatomegaly at least 5 cm below the costal margin on
     quiet respiration and ascribed to tumor (biopsy
     confirmation required if hepatomegaly is the sole
     indicator lesion)

     Circulating Sezary cells at least 1,000

  Evaluable disease defined as lesions that can be evaluated by
  independent reviewers (e.g., by chest x-ray, scans,
  photographs) but cannot be clearly measured

  Malignant pleural effusion and ascites are not considered
  evaluable

Prior/Concurrent Therapy:

At least 3 weeks since therapy

Biologic therapy:
  Not specified

Chemotherapy:
  No chemotherapy within 3 weeks of entry

Endocrine therapy:
  Corticosteroids allowed provided:
     Dose has been stable for the past 2 weeks
     Dose is no more than 20 mg/day of prednisone or equivalent

Radiotherapy:
  No concurrent radiotherapy

Surgery:
  Not specified

Patient Characteristics:

Age:
  18 and over

Performance status:
  ECOG 0-3

Life expectancy:
  Greater than 1 month

Hematopoietic:
  See Disease Characteristics

Hepatic:
  Not specified

Renal:
  Not specified

Other:
  No uncontrolled infection
  No uncontrolled diabetes mellitus
  No second malignancy that would require chemotherapy or
     radiotherapy within 6 months
  No pregnant or lactating women

Expected Enrollment

Initially, 15 patients in each disease category will be entered.  If fewer 
than 5 responses (CR, PR, or regression) are seen, further entry of patients 
with that disease category will cease; otherwise, an additional 20 patients 
with that disease will be entered.  Accrual is expected to be completed in 4 
years.

Outline

Somatostatin Analogue Therapy.  Sandostatin, Octreotide, SSTN.

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

Mayo Clinic Cancer Center

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