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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center; Spectrum Pharmaceuticals, Inc
• Collaborators: Memorial Sloan Kettering Cancer Center; National Cancer Institute (NCI)
• Treatments: 10-deazaaminopterin; Aminopterin

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