Overview

Arsenic Trioxide in Treating Patients With Relapsed or Refractory Non- Hodgkin's Lymphoma

Status:
Completed
Trial end date:
2001-07-01
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 II trial to study the effectiveness of arsenic trioxide in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Arsenic Trioxide
Criteria
DISEASE CHARACTERISTICS: Histologically proven non-Hodgkin's lymphoma (NHL) that has
relapsed following or is resistant to at least 1 standard anticancer therapy or for which
no curative therapy exists Intermediate or high grade NHL of one of the following types:
Transformed low grade Diffuse small cleaved cell Diffuse large cell (including diffuse
mixed cell and immunoblastic large cell) Primary mediastinal B-cell Follicular large cell
(follicular center cell or grade III follicular cell) Anaplastic large cell Angiocentric
(including nasal T-cell and pulmonary B-cell) Angioimmunoblastic T-cell lymphoma Peripheral
T-cell Intestinal T-cell Intravascular lymphomatosis Lymphoblastic Diffuse small noncleaved
cell/Burkitt's Adult T-cell leukemia/lymphoma Mantle cell Measurable disease A new
classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The
terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of
"low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former
terminology.

PATIENT CHARACTERISTICS: Age: 17 and over Performance status: Karnofsky 60-100% Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than
1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 50
mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception during and for at least 4 months after study No active serious
infection that is not controlled by antibiotics No grade 3 or worse preexisting
neurological abnormality, regardless of causality HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 2
other prior chemotherapy regimens (e.g., one frontline plus one salvage regimen) At least 2
weeks since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy:
At least 1 month since prior radiotherapy and recovered Surgery: Not specified Other: See
Disease Characteristics At least 2 weeks since other prior investigational agents and
recovered No concurrent intrathecal drugs