A Phase II Study of 10-Propargyl-10-Deazaaminopterin (PDX) in Relapsed or Refractory Aggressive Non-Hodgkin's Lymphomas and Hodgkin's Disease
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Owen A. O'Connor, MD, PhD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
CDR0000258425
NCT00052442
August 2002
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |