NCT00052442

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1 lymphoma

Timeline
Completed

Started Aug 2002

Typical duration for phase_1 lymphoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
12.5 years until next milestone

Results Posted

Study results publicly available

August 25, 2021

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

6.6 years

First QC Date

January 24, 2003

Results QC Date

June 26, 2014

Last Update Submit

August 20, 2021

Conditions

Lymphoma

Keywords

recurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult Burkitt lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent mantle cell lymphomarecurrent adult Hodgkin lymphomarecurrent grade 3 follicular lymphoma

Outcome Measures

Primary Outcomes (1)

  • Response Rate

    Per Response Evaluation Criteria in T-cell and B-cell Lymphoma for target lesions and assessed using computerized tomography (CT) and or Positron emission tomography CT (PET CT) by local investigators: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=50% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    3 weeks

Secondary Outcomes (1)

  • Toxicities of Pralatrexate

    3 weeks

Study Arms (5)

135 mg/m^2 Pralatrexate 1/2 weeks

EXPERIMENTAL

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.

Drug: pralatrexate

30 mg/m^2 Pralatrexate 3/4 weeks

EXPERIMENTAL

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.

Drug: pralatrexate

30 mg/m^2 Pralatrexate 6/7 weeks

EXPERIMENTAL

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 6/7 weeks.

Drug: pralatrexate

45 mg/m^2 Pralatrexate 6/7 weeks

EXPERIMENTAL

PDX 45 mg/m\^2 administered as an IV infusion over 15 minutes into a side arm of a running intravenous infusion of normal saline for 6/7 weeks.

Drug: pralatrexate

270 mg/m^2 Pralatrexate 2/4 weeks

EXPERIMENTAL

PDX (270 mg/m\^2) administered as an IV bolus over 3-5 minutes into a side arm of a running intravenous infusion of normal saline for 2/4 weeks.

Drug: pralatrexate

Interventions

pralatrexateDRUG
Also known as: Folotyn, 10-Propargyl-10-Deazaaminopterin (PDX)
135 mg/m^2 Pralatrexate 1/2 weeks270 mg/m^2 Pralatrexate 2/4 weeks30 mg/m^2 Pralatrexate 3/4 weeks30 mg/m^2 Pralatrexate 6/7 weeks45 mg/m^2 Pralatrexate 6/7 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

  • O'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: 19652067RESULT

MeSH Terms

Conditions

LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinBurkitt LymphomaLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, Mantle-CellHodgkin DiseaseLymphoma, Follicular

Interventions

10-propargyl-10-deazaaminopterin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, LymphoidLeukemiaHematologic Diseases

Limitations and Caveats

Study completed

Results Point of Contact

Title
Owen A. O'Connor, MD, PhD
Organization
Memorial Sloan-Kettering Cancer Center
oo2130@columbia.edu
212-639-8889

Study Officials

  • Owen A. O'Connor, MD, PhD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2003

First Posted

January 27, 2003

Study Start

August 1, 2002

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

August 25, 2021

Results First Posted

August 25, 2021

Record last verified: 2021-08

Locations

US(1)