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aminopterin

leucovorin calcium

Barton A. Kamen, MD, PhD

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of aminopterin in treating patients who have refractory leukemia.

OBJECTIVES: I. Determine the maximum tolerated dose of aminopterin in patients with refractory leukemia and minimal previous exposure to antifolate agents. II. Determine the antileukemic activity of aminopterin in adults and children with acute myelogenous and acute lymphoblastic leukemia for whom conventional therapy has failed. III. Confirm that aminopterin can be administered for four consecutive weeks when followed with minimal leucovorin calcium rescue and determine the minimal amount of leucovorin calcium required for each patient. IV. Confirm bioavailability data on oral aminopterin by performing limited sampling pharmacokinetics. V. Correlate blast uptake of aminopterin in vitro with clinical response.

OUTLINE: This is an open label study. Patients are stratified according to age and type of leukemia: Stratum I: Under 20 years old with acute lymphoblastic leukemia (ALL) in second or greater relapse Stratum II: Greater than 20 years old with ALL in first or greater relapse Stratum III: Patients of any age with acute myelogenous leukemia (AML) in first or greater relapse Patients receive aminopterin every 12 hours for 2 doses weekly for 4 weeks. Aminopterin is administered intravenously over 20 minutes for the first, second, and fourth doses, and orally for the third dose. The fifth and all subsequent doses are administered orally if bioavailability is acceptable. Patients receive oral leucovorin calcium every 12 hours for 2 doses beginning 24 hours after the last dose of aminopterin each week. If toxicity is limited for 2 consecutive weeks, the dose of leucovorin calcium is decreased to 1 dose administered 24 hours after the last dose of aminopterin each week. If this schedule is tolerated for 2 consecutive weeks, then leucovorin calcium is discontinued. Patients continue therapy for up to 15 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months.

PROJECTED ACCRUAL: This study will accrue a maximum of 25 patients per stratum, for a total of 75 patients, within 3 years.

Aminopterin in Treating Patients With Refractory Leukemia

A Phase II Trial of Aminopterin in Adults and Children With Refractory Acute Leukemia Grant Application Title: A Phase II Trial of Aminopterin in Acute Leukemia

Genzyme, a Sanofi Company

Lymphoma

Lymphoproliferative Disorders

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Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Cytarabine

Cyclophosphamide

Dexamethasone

Methotrexate

Vincristine

Daunorubicin

Dexamethasone acetate

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Thioguanine

Asparaginase

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Alkylating Agents

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Antineoplastic Agents, Hormonal

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6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin

6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C

Therapy will be divided into five phases: Induction, Consolidation, Delayed Intensification (only for those patients meeting clinical criteria defining a high risk of relapse), Intensive Continuation, and Continuation

L-asparaginase

cyclophosphamide

cytarabine

daunomycin

dexamethasone

6-mercaptopurine

methotrexate

6-thioguanine

vincristine

Triple Intrathecal Therapy (MTX, Cytarabine, Hydrocortisone)

Barton Kamen, MD

The purpose of this research study is to identify better ways to treat children and young adults with acute lymphocytic leukemia (ALL). At the same time, doctors hope to define methods to identify those patients at higher risk for certain side effects, as well as those who are at higher risk for relapse of their leukemia.

Outline of Therapy:

Combinations of chemotherapy drugs will be given orally, intravenously and intrathecally (directly into the cerebrospinal fluid by spinal tap) over a period of roughly two and a half years.

Therapy will be divided into five phases:

Induction (4 weeks): chemotherapy given to produce a clinical remission (defined by normal blood counts, with the absence of leukemia cells in the blood and fewer than 5% leukemia cells in the bone marrow).

Consolidation (11 weeks): chemotherapy given to consolidate the remission. Delayed Intensification (7 weeks) Intensive chemotherapy aimed at killing any resistant leukemia cells will be given only for patients at high risk of relapse.

Intensive Continuation (approximately 1 year): Eight week cycles of chemotherapy, given eight times.

Continuation (final year of therapy): Eight week cycles of largely oral chemotherapy, with one clinic visit for a lumbar puncture every eight weeks.

Irradiation: radiation will be given in the middle of intensive continuation to the head and spine of those patients who have leukemia cells found in the cerebrospinal fluid at the time of diagnosis.

Follow-up: After the conclusion of therapy, there will be periodic office visits, initially monthly, then gradually spaced out to annual visits. The purpose of these visits is to evaluate for late side-effects of therapy.

CINJALL: Treatment for Children With Acute Lymphocytic Leukemia

This measure looks at the percentage of patients on Arm 2 who did not experience a relapse at 5 years, where relapse is defined as the presence of progressive disease after the achievement of a complete remission.

National Cancer Institute (NCI)

Rutgers, The State University of New Jersey

Arm 1 Standard Risk

Arm 2 High Risk

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Antifolate therapy was non-randomly assigned, therefore, we do not have a statistical basis to compare the toxicity observed among patients on the standard risk and high risk treatment arms.

Richard Drachtman, MD

Number of high risk ALL patients treated.

Percentage of Patients With ALL at High Risk of Relapse (Arm 2) Who Were Relapse-free at 5 Years

We did not analyze this outcome measure. The laboratory analysis was not performed. The Principal Investigator left the institution.

To Measure 5-methyltetrahydrofolate, Aminopterin and Methotrexate Uptake in Leukemic Blasts Isolated at Diagnosis

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Aminopterin in Treating Patients With Refractory Leukemia	NCT00003305	Leukemia	aminopterin leucovorin calc...	-	National Cancer Institute (NCI)
CINJALL: Treatment for Children With Acute Lymphocytic Leukemia	NCT00176462	Acute Lymphocyt...	aminopterin L-asparaginase cyclophosphamid... cytarabine daunomycin dexamethasone 6-mercaptopurin... methotrexate 6-thioguanine vincristine Triple Intrathe... Leucovorin	1 Year - 30 Years	Rutgers, The State University of New Jersey

Spots Global Cancer Trial Database for aminopterin

Every month we try and update this database with for aminopterin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for aminopterin

Every month we try and update this database with for aminopterin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for aminopterin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.