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

This study has been completed.

Sponsors and Collaborators: National Cancer Institute (NCI)
Memorial Sloan-Kettering Cancer Center
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade III follicular large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma
recurrent adult T-cell leukemia/lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent angiocentric immunoproliferative lesions
recurrent mantle cell lymphoma
recurrent adult diffuse large cell lymphoma
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
 Drug: arsenic trioxide
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Immune System and Disorders;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphatic Diseases;   Lymphoma;   Viral Infections

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Arsenic Trioxide in Patients With Relapsed or Refractory Intermediate or High Grade Non-Hodgkin's Lymphoma

Further Study Details: 

Study start: January 2000

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.

PROTOCOL 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 above

Criteria

PROTOCOL ENTRY 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.]

--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

--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

Location Information


New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

David J. Straus,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067631; MSKCC-99051; NCI-T99-0062
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  April 6, 2000
ClinicalTrials.gov Identifier:  NCT00005040
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005