Overview

PS-341 in Treating Patients With Hematologic Cancer

Status:
Completed
Trial end date:
2001-10-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: PS-341 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase I trial to study the effectiveness of PS-341 in treating patients who have hematologic cancer.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Bortezomib
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed hematologic malignancy including: Acute
myeloid leukemia Chronic myelogenous leukemia Acute lymphoblastic leukemia Chronic
lymphocytic leukemia Hodgkin's disease Non-Hodgkin's lymphoma Multiple myeloma
Myelodysplastic syndrome subtypes: Refractory anemia with excess blasts (RAEB) RAEB in
transformation Refractory to standard treatment or no curative therapy available Measurable
disease Not eligible for higher priority study

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 6 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least
1,000/mm3 Platelet count at least 50,000/mm3 Hematocrit at least 25% Hepatic: SGOT and SGPT
less than 2.5 times upper limit of normal (ULN) Bilirubin less than 1.5 times ULN Renal:
Creatinine clearance greater than 50 mL/min Cardiovascular: No acute ischemia or new
conduction system abnormalities by EKG No prior myocardial infarction within past 6 months
No New York Heart Association class III or IV congestive heart failure Other: Febrile
episodes up to 38.5 degrees C due to tumor fever allowed No concurrent active infection No
grade 1 or greater National Cancer Institute common toxicity criteria No serious medical or
psychiatric condition that would preclude study Not pregnant or nursing Negative pregnancy
test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy No
concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy No other
concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks
since prior radiotherapy No concurrent radiotherapy Surgery: At least 2 weeks since prior
major surgery