KRN7000 in Treating Patients With Solid Tumors

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Biological therapies such as KRN7000 use different ways to stimulate the immune system and stop cancer cells from growing.

PURPOSE: Phase I trial to study the effectiveness of KRN7000 in treating patients who have solid tumors that have not responded to previous treatment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: KRN 7000

Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven solid tumor that is refractory to conventional treatment or for which no curative or standard palliative treatment exists No brain involvement or leptomeningeal disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG/WHO 0-2 Life expectancy:

At least 3 months Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Lymphocyte count at least 600/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST and ALT no greater than 2.5 times upper limit of normal No liver cirrhosis Hepatitis B surface antigen negative Renal: Creatinine no greater than 1.4 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No New York Heart Association class III or IV heart disease Immunologic: No immunodeficiency No autoimmune disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection No nonmalignant disease incompatible with study No prior alcoholism, drug addiction, or psychotic disorders unless suitable for adequate follow up No cerebroside metabolite abnormalities (e.g., Gaucher's disease) HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior immunotherapy No concurrent cytokines Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, and high dose chemotherapy) Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy (6 weeks for extensive radiotherapy) No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational or antitumor drugs