Clinical trial · Interventional
10-Propargyl-10-Deazaaminopterin in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma
A Phase II Study of 10-Propargyl-10-Deazaaminopterin (PDX) in Relapsed or Refractory Aggressive Non-Hodgkin's Lymphomas and Hodgkin's Disease
NCT00052442CI-TRIAL-00053507completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pralatrexate | Drug | Pralatrexate | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- 135 mg/m^2 Pralatrexate 1/2 weeks
- description
- Pralatrexate (PDX) 135 mg/m\^2 administered as an intravenous (IV) infusion over one hour into a side arm of a running intravenous infusion of normal saline for 1/2 weeks.
- interventionNames
- Drug: pralatrexate
- type
- EXPERIMENTAL
- label
- 30 mg/m^2 Pralatrexate 3/4 weeks
- description
- PDX 30 mg/m\^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 3/4 weeks.
- interventionNames
- Drug: pralatrexate
- type
- EXPERIMENTAL
- label
- 30 mg/m^2 Pralatrexate 6/7 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed Hodgkin's lymphoma or, using the World Health Organization (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 centimeter (cm) by conventional techniques OR * At least 1 cm by spiral computerized tomography (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 peripheral blood stem cells (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 Central nervous system (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) * Aspartate aminotransferase/alanine aminotransferase (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 ECG 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 human immunodeficiency virus (HIV)-positive patients * No other concurrent investigational or commercial agents or therapies with the intent to treat the malignancy
References
Publications (1)
- RESULTO'Connor OA, Horwitz S, Hamlin P, Portlock C, Moskowitz CH, Sarasohn D, Neylon E, Mastrella J, Hamelers R, Macgregor-Cortelli B, Patterson M, Seshan VE, Sirotnak F, Fleisher M, Mould DR, Saunders M, Zelenetz AD. Phase II-I-II study of two different doses and schedules of pralatrexate, a high-affinity substrate for the reduced folate carrier, in patients with relapsed or refractory lymphoma reveals marked activity in T-cell malignancies. J Clin Oncol. 2009 Sep 10;27(26):4357-64. doi: 10.1200/JCO.2008.20.8470. Epub 2009 Aug 3. PMID 19652067