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Phase 2 Completed N=72 Treatment

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

Source: ClinicalTrials.gov NCT00052442 ↗
Enrolled (actual)
72
Serious AEs
61.1%
Results posted
Aug 2021
Primary outcomePrimary: Response Rate — 15; 3; 27; 11 Participants

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Response Rate
15; 3; 27; 11; 15
SECONDARY
Toxicities of Pralatrexate
16; 3; 27; 11; 15

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00052442). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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