Expired Study
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New York, New York 10021


RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of 10-propargyl-10-deazaaminopterin in treating patients who have recurrent or refractory non-Hodgkin's lymphoma or Hodgkin's lymphoma.

Study summary:

OBJECTIVES: - Determine the efficacy of 10-propargyl-10-deazaaminopterin, in terms of objective response rate, duration of response, and time to disease progression, in patients with relapsed or refractory aggressive non-Hodgkin's lymphoma or Hodgkin's lymphoma. - Determine the impact of pharmacokinetics on toxicity and drug elimination in patients treated with this drug. - Determine the toxicity of this drug in these patients. - Determine the effect of prior chemotherapy response duration on duration of response in patients treated with this drug. - Correlate, if possible, the pharmacodynamics (area under the curve) of this drug with tumor response and toxicity (mucositis) in these patients. - Correlate, if possible, intraerythrocytic folate or homocysteine levels with severity of mucositis in patients treated with this drug. - Determine whether levels of the RFC-1 folate transporter, folylpolyglutamate synthetase, and folylpolyglutamate hydrolase are markers of response in patients treated with this drug. OUTLINE: This is an open-label study. Patients receive 10-propargyl-10-deazaaminopterin IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) may receive 2 additional courses beyond the CR. PROJECTED ACCRUAL: A total of 39-72 patients (12-35 for cohort 1 and 17-37 for cohort 2) will be accrued for this study within 10-36 months.


DISEASE CHARACTERISTICS: - Histologically confirmed Hodgkin's lymphoma or, using the WHO classification, aggressive non-Hodgkin's lymphoma including: - Large B- or T-cell lymphomas (including transformed lymphomas) - Mantle cell lymphoma - Immunoblastic lymphoma - At least 1 unidimensionally measurable lesion - At least 2 cm by conventional techniques OR - At least 1 cm by spiral CT scan - Lymph nodes no greater than 1 cm in the short axis are considered normal - Relapsed or refractory disease after first-line chemotherapy - Cohort 1: - No more than 3 prior conventional cytotoxic chemotherapy regimens - Must have had at least a partial response (PR) lasting no more than 6 months or refractory disease - Patients with disease refractory to or relapsed less than 100 days from peripheral blood stem cell (PBSC) transplantation are not eligible - Cohort 2: - No limit on prior treatment - Must have had at least a PR to the last therapy lasting at least 6 months - Patients who have received high-dose chemotherapy as part of PBSC transplantation are eligible if relapse occurred at least 100 days after transplantation - No clinically significant pleural effusions or ascites - No active brain or leptomeningeal metastases - Treated CNS disease allowed PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% Life expectancy - Not specified Hematopoietic - Absolute neutrophil count greater than 1,000/mm^3 - Platelet count greater than 75,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic - Bilirubin less than 1.5 times upper limit of normal (ULN) - AST/ALT no greater than 2.5 times ULN (4 times ULN if liver involvement) - Alkaline phosphatase no greater than 5 times ULN Renal - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 50 mL/min Cardiovascular - No symptomatic congestive heart failure - No New York Heart Association class III or IV heart disease - No unstable angina pectoris - No cardiac arrhythmia - No myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months - No history of orthostatic hypotension - No EKG evidence of acute ischemia or significant conduction abnormality (e.g., bifascicular block or 2nd or 3rd degree atrioventricular blocks) - No uncontrolled hypertension requiring active manipulation of antihypertensive medications - No grade III or IV edema Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No ongoing or active infection - Febrile episodes up to 38.5° Celsius without signs of active infection allowed - No other concurrent active cancer - No other concurrent serious medical illness - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - At least 3 months since prior monoclonal antibody therapy (e.g., rituximab) Chemotherapy - See Disease Characterisitics - At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered Endocrine therapy - At least 7 days since prior steroids - No concurrent steroids Radiotherapy - See Disease Characteristics - At least 4 weeks since prior radiotherapy and recovered Surgery - More than 4 weeks since prior major surgery Other - No prior antifolates - No concurrent folic acid supplementation - No other concurrent investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients - No other concurrent investigational or commercial agents or therapies with the intent to treat the malignancy



Primary Contact:

Study Chair
Owen A. O'Connor, MD, PhD
Memorial Sloan-Kettering Cancer Center

Backup Contact:


Location Contact:

New York, New York 10021
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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