Overview

PS-341 in Treating Patients With Advanced Solid Tumors or Lymphoma

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of PS-341 in treating patients who have advanced solid tumors or lymphoma that have not responded to previous treatment.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
New York University School of Medicine
NYU Langone Health
Collaborator:
National Cancer Institute (NCI)
Treatments:
Bortezomib
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed advanced solid tumor or lymphoma that has
failed standard therapy and no standard options available No leukemia or myeloma CNS
lesions allowed if adequately treated by surgery and/or radiotherapy and symptomatically
stable on maintenance glucocorticoids and not requiring anticonvulsants for at least 3
months

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not
specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at
least 100,000/mm3 Hepatic: SGOT no greater than 2.5 times upper limit of normal Bilirubin
no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No
acute ischemia or significant conduction abnormality (i.e., bifascicular block or 2nd or
3rd degree AV blocks) Other: No other serious medical or psychiatric illness Not pregnant
or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow transplantation with
high-dose chemotherapy or radiolabeled monoclonal antibody therapy for lymphoma patients
Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas)
Endocrine therapy: See Disease Characteristics Radiotherapy: At least 4 weeks since prior
radiotherapy Surgery: At least 2 weeks since prior major surgery Other: See Disease
Characteristics No concurrent antiretroviral therapy