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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00052442 |
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 | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: pralatrexate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed Hodgkin's lymphoma or, using the WHO classification, aggressive non-Hodgkin's lymphoma including:
At least 1 unidimensionally measurable lesion
Cohort 1:
Cohort 2:
No active brain or leptomeningeal metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
No ongoing or active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Owen A. O'Connor, MD, PhD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000258425, MSKCC-02078, NCI-H02-0100 |
Study First Received: | January 24, 2003 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00052442 History of Changes |
Health Authority: | United States: Federal Government |
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 |
Lymphoma, Mantle-Cell Lymphoma, Follicular Folate Aminopterin Mantle Cell Lymphoma Follicular Lymphoma Lymphoblastic Lymphoma Vitamin B9 Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, Large-Cell, Immunoblastic 10-deazaaminopterin Aggression Lymphoma, Large-cell Hodgkin Disease |
Lymphoma Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Hodgkin Lymphoma, Adult Hodgkin's Disease Folinic Acid Folic Acid Antagonists Recurrence Folic Acid Lymphatic Diseases Burkitt's Lymphoma Burkitt Lymphoma Lymphoproliferative Disorders Lymphoma, Non-Hodgkin |
Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Aminopterin Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions |
Lymphatic Diseases Neoplasms Therapeutic Uses 10-deazaaminopterin Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Hodgkin Disease Lymphoma |