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

Lymphoma Clinical Trial

Official title:

Phase II Study of Arsenic Trioxide (NSC #706363) in Relapsed and Refractory Intermediate and High-Grade Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005040
• Other study ID #: 99-051
• Secondary ID: CDR0000067631NCI
• Status: Completed
• Phase: Phase 2
• First received: April 6, 2000
• Last updated: June 18, 2013
• Start date: January 2000
• Est. completion date: July 2001

Study information

• Verified date: June 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES: I. Determine the complete and partial response rates, duration of complete response, freedom from progression, event free survival, and overall survival in patients with relapsed or refractory intermediate or high grade lymphoma treated with arsenic trioxide. II. Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive arsenic trioxide IV over 2-4 hours for a maximum of 25 cumulative days followed by a rest period of 3-4 weeks. Patients with complete or partial response may receive 6 additional courses in the absence of disease progression or unacceptable toxicity. Patients with minor response (25-50% tumor regression) may also receive further courses of treatment. Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 22-41 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2001
• Est. primary completion date: July 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• arsenic trioxide

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,