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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00005040
First received: April 6, 2000
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: arsenic trioxide
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of Arsenic Trioxide (NSC #706363) in Relapsed and Refractory Intermediate and High-Grade Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Study Start Date: January 2000
Study Completion Date: July 2001
Primary Completion Date: July 2001 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005040

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: David J. Straus, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00005040     History of Changes
Other Study ID Numbers: 99-051, CDR0000067631, NCI-T99-0062
Study First Received: April 6, 2000
Last Updated: June 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
recurrent adult grade III lymphomatoid granulomatosis
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
recurrent adult T-cell leukemia/lymphoma
recurrent mantle cell lymphoma
angioimmunoblastic T-cell lymphoma
anaplastic large cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Arsenic trioxide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014