Arsenic Trioxide in Treating Patients With Recurrent or Refractory Acute Leukemia, Chronic Myeloide Leukemia, Myelodysplasia, Lymphoma, or Myeloma

Lymphoma Clinical Trial

Official title:

Phase II Study of Arsenic Trioxide in Relapsed/Refractory Acute Leukemia and Blast Crisis of Chronic Myeloid Leukemia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00003885
• Other study ID #: CDR0000067053
• Secondary ID: OLMMC-9808OLMMC-
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: November 5, 2013
• Start date: November 1997

Study information

• Verified date: June 2000
• Source: National Cancer Institute (NCI)
• 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 recurrent or refractory acute leukemia, chronic myeloid leukemia, myelodysplasia, lymphoma, or myeloma.

Description:

OBJECTIVES: I. Determine the effect of arsenic trioxide on the remission rate in patients with recurrent or refractory acute leukemia, blast crisis chronic myeloid leukemia, myelodysplasia, lymphoma, or myeloma. II. Determine the time to progression and survival in patients treated with this regimen. III. Determine the toxic effects of this regimen in these patients.

OUTLINE: Patients are stratified into 1 of 8 categories: first relapse no greater than 6 months after complete response vs second relapse or refractory vs prior hematologic disorder vs myeloid blast crisis of chronic myeloid leukemia vs lymphoid leukemia vs lymphoma vs myeloma vs myelodysplasia. Patients receive IV arsenic trioxide over 2-3 hours for 5 consecutive days with 2 days of rest. Treatment continues in the absence of disease progression until complete response or 90 days is reached. Upon achieving complete response, treatment is discontinued for 30 days. Patients exhibiting complete response receive a second 28 day course of consolidation therapy while in remission starting no sooner than 31 days after the end of induction therapy. Patients are followed monthly.

PROJECTED ACCRUAL: A total of 14-29 patients per lymphoma and myeloma stratum and a total of 31 patients per leukemia stratum will be accrued for this study within 18-24 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory acute leukemia (myeloid or lymphoid), blast crisis chronic myeloid leukemia, myelodysplasia, lymphoma, or myeloma of all FAB subtypes

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 6 weeks Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL (except for leukemic infiltration dysfunction) Alkaline phosphatase less than 2 times upper limit of normal (except for leukemic infiltration dysfunction) Renal: Creatinine no greater than 2.0 mg/dL Other: No active infection Not pregnant Fertile patients must use effective contraception No history of seizure disorders

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 2 weeks since prior chemotherapy (except hydroxyurea) No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational agents Concurrent antibiotic therapy allowed for stable patients

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Neoplasms, Plasma Cell
• Plasmacytoma
• Preleukemia

Intervention

Drug:
• arsenic trioxide

Locations

Country	Name	City	State
United States	Our Lady of Mercy Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Our Lady of Mercy Medical Center

Country where clinical trial is conducted

United States,