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


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Adult Hodgkin's Lymphoma


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

This study has been suspended.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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 Treatment or Intervention Phase
adult Hodgkin's lymphoma
adult non-Hodgkin's lymphoma
 Drug: 10-propargyl-10-deazaaminopterin
 Procedure: chemotherapy
Phase II

MedlinePlus related topics:  Hodgkin's Disease;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of 10-Propargyl-10-Deazaaminopterin in Patients With Recurrent or Refractory Aggressive Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma

Further Study Details: 

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

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

Chemotherapy

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


Location Information


New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

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

More Information

Study ID Numbers:  CDR0000258425; MSKCC-02078; NCI-H02-0100
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  January 24, 2003
ClinicalTrials.gov Identifier:  NCT00052442
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005


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October 10, 2008



Page Updated: September 6, 2005
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