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



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

For Condition: angioimmunoblastic T-cell lymphoma,recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma,recurrent angiocentric immunoproliferative lesions,recurrent adult diffuse small cleaved cell lymphoma,anaplastic large cell lymphoma,recurrent adult T-cell leukemia/lymphoma,recurrent grade III follicular large cell lymphoma,recurrent adult immunoblastic large cell lymphoma,recurrent adult diffuse large cell lymphoma,recurrent mantle cell lymphoma,recurrent adult diffuse mixed cell lymphoma,recurrent adult lymphoblastic lymphoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 17 Years/
Genders: 
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
DavidStraus,  Study Chair,  Memorial Sloan-Kettering Cancer Center

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


Additional Information:
Study ID Numbers:
  CDR0000067631;  MSKCC-99051,NCI-T99-0062
Study Start Date: January 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005040

Other Recurrent Adult Immunoblastic Large Cell Lymphoma Studies:
1. Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

2. Rituximab and Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

3. Paclitaxel and Estramustine in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

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

5. Peripheral Stem Cell Transplantation Following Radiation Therapy in Treating Patients With Hodgkin's Disease or Non-Hodgkin's Lymphoma

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

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