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

Phase 2
17 Years
Not Enrolling

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Trial Information

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

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.

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David J. Straus, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Federal Government

Study ID:




Start Date:

January 2000

Completion Date:

July 2001

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, Non-Hodgkin



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