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10-Propargyl-10-Deazaaminopterin in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00052442
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 4, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: pralatrexate Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of 10-Propargyl-10-Deazaaminopterin (PDX) in Relapsed or Refractory Aggressive Non-Hodgkin's Lymphomas and Hodgkin's Disease
Study Start Date : August 2002
Actual Primary Completion Date : March 2009

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified


  • Absolute neutrophil count greater than 1,000/mm^3
  • Platelet count greater than 75,000/mm^3
  • Hemoglobin at least 10 g/dL


  • 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


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 50 mL/min


  • 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


  • 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


Biologic therapy

  • See Disease Characteristics
  • At least 3 months since prior monoclonal antibody therapy (e.g., rituximab)


  • 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


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered


  • More than 4 weeks since prior major surgery


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00052442

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Study Chair: Owen A. O'Connor, MD, PhD Memorial Sloan Kettering Cancer Center
Publications of Results:
Layout table for additonal information Identifier: NCT00052442    
Other Study ID Numbers: CDR0000258425
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 4, 2013
Last Verified: December 2009
Keywords provided by National Cancer Institute (NCI):
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent mantle cell lymphoma
recurrent adult Hodgkin lymphoma
recurrent grade 3 follicular lymphoma
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases