Arsenic Trioxide in Treating Patients With Relapsed or Refractory Non- Hodgkin's Lymphoma
| Tracking Information | |||||
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| First Received Date ICMJE | April 6, 2000 | ||||
| Last Updated Date | August 7, 2008 | ||||
| Start Date ICMJE | January 2000 | ||||
| Primary Completion Date | July 2001 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00005040 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Arsenic Trioxide in Treating Patients With Relapsed or Refractory Non- Hodgkin's Lymphoma | ||||
| Official Title ICMJE | Phase II Study of Arsenic Trioxide (NSC #706363) in Relapsed and Refractory Intermediate and High-Grade Non-Hodgkin's Lymphoma | ||||
| Brief 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 relapsed or refractory non-Hodgkin's lymphoma. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Primary Purpose: Treatment | ||||
| Condition ICMJE | Lymphoma | ||||
| Intervention ICMJE | Drug: arsenic trioxide | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | Not Provided | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | July 2001 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | 17 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00005040 | ||||
| Other Study ID Numbers ICMJE | CDR0000067631, MSKCC-99051, NCI-T99-0062 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | September 2001 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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