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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 to 74 EORTC-16824

Objectives

I.  Determine the therapeutic efficacy, in terms of response rate and duration 
of response, of spirogermanium in adult patients with advanced Hodgkin's 
disease and non-Hodgkin's lymphomas refractory to prior chemotherapy with or 
without radiotherapy.
II.  Determine the toxicity associated with spirogermanium administration in 
these patients.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Adult patients under the age of 75 
years with histologically proven Hodgkin's disease or non-Hodgkin's lymphoma 
(excluding CLL and DLWD non-Hodgkin's lymphoma in leukemic phase).  Disease 
must be progressive and resistant to conventional chemotherapy.  There must be 
at least one clinically and/or radiologically measurable disease parameter; 
prior radiotherapy to a measurable lesion is acceptable provided that 
radiotherapy was not administered during the 3 weeks prior to entry and that 
there has been clearly demonstrated evidence of progression.  There may have 
been no cytotoxic chemotherapy or radiotherapy within 3 weeks of admission (4 
weeks for nitrosoureas).  The expected survival must be at least 6 weeks and 
the WHO performance status 2 or less.  Hematopoietic, hepatic, and renal 
function must be adequate.  Per revision, protocol specifies no upper age 
limit for entry; patients must be more than 15 years old.

Expected Enrollment

Initially 14 patients will be entered into each group (Hodgkin's disease and 
low, intermediate, and high grade non-Hodgkin's lymphoma); if one or more 
responses are noted, additional patients will be entered.

Outline

Nonrandomized study.
Single-agent Chemotherapy.  Spirogermanium, SPG, NSC-192965.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Maurice J. Staquet, MD, Protocol chair		Ph: 32-2-541-3501

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