Neoplasms

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Anti-Dyskinesia Agents

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Leucovorin

Dexamethasone

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Doxorubicin

Liposomal doxorubicin

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Prednisone

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Ophthalmic Solutions

Daunorubicin

Lenograstim

Dexamethasone acetate

Mercaptopurine

Thioguanine

Asparaginase

Trimethoprim, Sulfamethoxazole Drug Combination

Allopurinol

Trimethoprim

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Immunosuppressive Agents

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Folinic Acid

Folate

Vitamin B9

Induc 1: Allopurinol; Daunorubicin; Vincristine; Prednisone; asparaginase; Bactrim Induc 2: Allopurinol; cytarabine; Dexamethasone; filgrastim; mitoxantrone; Methotrexate; leucovorin Consol: Cyclophosphamide; cytarabine; 6-mercaptopurine; Methotrexate; filgrastim Maint:Course 1: 6-mercaptopurine; Methotrexate Course 2: Vincristine; doxorubicin; Dexamethasone Course 3: Cyclophosphamidee; thioguanine; cytarabine Course 4: 6-mercaptopurine; methotrexate

filgrastim

Cyclophosphamide Consolidation: 650 mg/m2; IV; days 1, 15, 29 Post-consolidation course 3: 650 mg/m2; IV; day 1

cyclophosphamide

Induction 2: 3 g/m2; IV over 3 hrs; days 1-5 Consolidation: 75 mg/m2/d; IV push; days 2-5 and 16-19 Post-consolidation course 3: 75 mg/m2/d; IV push; days 3-6 and 10-13

cytarabine

Induction: 60 mg/m2/d; IV; days 1, 2, and 3

daunorubicin

Induction 2: 0.1% QID; eye drops; days 1-6 Post consolidation course 2: 10 mg/m2/d; PO; days 1-28

dexamethasone

Post consolidation: 25 mg/m2; IV; days 1, 8, 15, and 22

doxorubicin

For CNS during induction: 5 mg every 6 hrs for 4 doses; PO; days 1, 4, 8, 11, etx.; after methotrexate if WBC \< 3,000

leucovorin

Consolidation: 60 mg/m2; PO; days 1-28 Post-consolidation course 1: 60 mg/m2/d; PO; days 1-63 Post-consolidation course 4: 60 mg/m2/d; PO; daily for 2 yrs

mercaptopurine

Consolidation: 12 mg; intrathecal or intraventricularly; days 2, 9, 16, and 23 Post-consolidation course 1: 20 mg/m2/wk; PO; days 1, 8 15, 22, 29, 36, 43, 50, 57 Post-consolidation course 4: 20 mg/m2; PO; weekly for 2 yrs

methotrexate

mitoxantrone

Induction: 60 mg/m2/d; PO or IV; days 1-35

prednisone

Post-consolidation course 3: 60 mg/m2/d; PO; days 1-14

thioguanine

Induction: 1.4 mg/m2/d (2 mg max); IV; days 1, 8, 15, 22

vincristine

For CNS during consolidation: cranial radiation after blasts are no longer present in spinal fluid. Total dose of 1800 cGy over 2 wks in 10 fractions of 180 cGy 5 days/wk.

radiation therapy

allopurinol

1 double strenth tablet 2x/d, 2x/wk, PO, begin with prednisone

bactrim

Jerry Radich, MD

Frederick R. Appelbaum, MD

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy), and giving the drugs in different combinations may kill more cancer cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed acute lymphoblastic leukemia.

OBJECTIVES:

Primary

* Determine the probability of 1-year continuous complete remission in patients with newly diagnosed acute lymphoblastic leukemia treated with first induction chemotherapy comprising daunorubicin, vincristine, prednisone, and pegaspargase; and second induction chemotherapy comprising high-dose cytarabine and mitoxantrone.

Secondary

* Determine the frequency and severity of toxic effects of these induction regimens followed by consolidation therapy comprising cyclophosphamide, cytarabine, mercaptopurine, and methotrexate and maintenance chemotherapy comprising mercaptopurine, methotrexate, vincristine, doxorubicin, dexamethasone, cyclophosphamide, thioguanine, and cytarabine in these patients.

Other objectives (if funding allows):

* To evaluate in a preliminary manner the significance of detecting minimal residual disease as a prognostic factor for survival and relapse-free survival of patients receiving chemotherapy
* To evaluate in a preliminary manner the pattern of gene expression of patients entered onto the trial and its relationship to cytogenetics/FISH risk classification, overall survival, and relapse-free survival

OUTLINE: This is a multicenter study.

* First induction chemotherapy: Patients receive daunorubicin IV on days 1-3; vincristine IV on days 1, 8, 15, and 22; prednisone IV or orally on days 1-28, followed by a taper to day 35; and pegaspargase IV or subcutaneously (SC) on day 15. Patients with CNS leukemia also receive methotrexate intrathecally (IT) or intraventricularly twice weekly and oral leucovorin calcium four times daily for 4 doses after each administration of methotrexate. When blasts are no longer present in the spinal fluid, patients receive methotrexate IT or intraventricularly once weekly for 4 weeks and then once monthly for 1 year.

Patients are reevaluated on day 28. Patients who achieve A1 bone marrow status and B1 peripheral blood status or those with resistant disease proceed to second induction therapy.

* Second induction chemotherapy: Patients receive high-dose cytarabine IV on days 1-5; mitoxantrone IV on day 3; and filgrastim (G-CSF) SC or IV beginning on day 7 and continuing until blood counts recover. Patients with CNS leukemia also receive methotrexate and leucovorin calcium as in first induction chemotherapy.

Patients are reevaluated on day 28. Patients who achieve A1 bone marrow status and B1 peripheral blood status with no extramedullary disease (other than CNS involvement) proceed to consolidation chemotherapy. Patients with resistant disease OR Philadelphia chromosome- or BCR/ABL-positive disease are removed from the study after receiving double induction chemotherapy.

* Consolidation chemotherapy: Patients receive cyclophosphamide IV on days 1, 15, and 29; cytarabine IV on days 2-5 and 16-19; oral mercaptopurine on days 1-28; and methotrexate IT or intraventricularly on days 2, 9, 16, and 23. Patients with CNS leukemia also undergo cranial radiotherapy once daily, 5 days a week, for 2 weeks.

Patients in complete remission proceed to maintenance chemotherapy.

* Maintenance chemotherapy:

  * Course 1: Patients receive oral mercaptopurine on days 1-63 and oral methotrexate on days 1, 8, 15, 22, 29, 36, 43, 50, and 57. Patients proceed to course 2 after blood counts recover.
  * Course 2: Patients receive vincristine IV and doxorubicin IV on days 1, 8, 15, and 22 and oral dexamethasone on days 1-28. Patients proceed to course 3 after blood counts recover.
  * Course 3: Patients receive cyclophosphamide IV on day 1; oral thioguanine on days 1-14; and cytarabine IV on days 3-6 and 10-13. Patients proceed to course 4 after blood counts recover.
  * Course 4: Patients receive oral mercaptopurine once daily for 2 years and oral methotrexate once weekly for 2 years.

Treatment continues in the absence of disease relapse or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.

S0333 Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

A Phase II Study of Double Induction Chemotherapy for Newly Diagnosed Non-L3 Adult Acute Lymphoblastic Leukemia With Investigation of Minimal Residual Disease and Risk of Relapse Following Maintenance Chemotherapy

A patient has a continuous complete remission at 1 year if they achieve a CR and are alive 365 days after registering to the study.

Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event

National Cancer Institute (NCI)

SWOG Cancer Research Network

Regular investigator assessments are reported after each cycle of protocol treatment

One induction cycle with allopurinol, daunorubicin, vincristine, prednisone, amd PEG- L-asparaginase.

First Induction

A second induction cycle with allopurinol , dexamergasone, G-CSF, high-dose ara-C and mitoxantrone

Second Induction

Patients who had a CR after induction could receive one course of consolidation therapy consisting of cyclophosphamide, ara-C, 6-mercaptopurine, G-CSF and methotrexate

Consolidation

Patient with a CR after consolidation could receive up to four courses of maintenance. Course 1 included 6-mercaptopurine and methotrexate. course 2 included vincristine, adriamycin, and dexamethasone. course 3 included cyclophosphamide, 6-thioguanine, and ara-C. course 4 included 6-mercaptopurine and methotrexate

Maintenance

Treatment included:

Induc 1: Allo; Dauno; Vin; Pred; asparag; Bactrim Induc 2: Allo; AraC; Dex; GCSF; Mitx; Meth; leuc; Meth Consol: cyclo; AraC; 6-mercapto; Meth; GCSF Maint:Course 1: 6-mercapto; Meth 20 Course 2: Vincristine; Adriamycin; Dex Course 3: Cyclo; 6-thio; AraC Course 4: 6-mercapto; meth

Treatment

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

SWOG Leukemia Statistician

The regimen would be of no further interest if the true 1-year continuous complete remission (CCR) rate was less than 45% (null). Sample size was chosen for an alternative of 65%, power of 92% and type-1 error of 4.6%.

Treatment included: Induc 1: Allo; Dauno; Vin; Pred; asparag; Bactrim Induc 2: Allo; AraC; Dex; GCSF; Mitx; Meth; leuc; Meth Consol: cyclo; AraC; 6-mercapto; Meth; GCSF Maint:Course 1: 6-mercapto; Meth 20 Course 2: Vincristine; Adriamycin; Dex Course 3: Cyclo; 6-thio; AraC Course 4: 6-mercapto; meth

Eligible, Ph-, treated, and evaluable patients

Continuous Complete Remission at 1 Year

ALT, SGPT (serum glutamic pyruvic transaminase)

AST, SGOT (serum glut oxaloacetic transaminase)

Albumin, serum-low (hypoalbuminemia)

Alkaline phosphatase

Anorexia

Ascites (non-malignant)

Bilirubin (hyperbilirubinemia)

Calcium, serum-low (hypocalcemia)

Cholecystitis

Cholesterol, serum-high (hypercholesterolemia)

Coagulation-Other (Specify)

Colitis, infectious (e.g., Clostridium difficile)

Constipation

DIC (disseminated intravascular coagulation)

Death not assoc with CTCAE term-Multi-organ fail

Edema: limb

Fatigue (asthenia, lethargy, malaise)

Febrile neutropenia

Fever (in the abs of neutropenia)

Fibrinogen

Glucose, serum-high (hyperglycemia)

Glucose, serum-low (hypoglycemia)

Hemoglobin

Hypertension

Hypotension

Hypoxia

Ileus, GI (functional obstruction of bowel)

Infec(doc clin or mibio) w/ Gr 3/4 neut-Anal

Infec(doc clin or mibio) w/ Gr 3/4 neut-Bladder

Infec(doc clin or mibio) w/ Gr 3/4 neut-Blood

Infec(doc clin or mibio) w/ Gr 3/4 neut-Bronchus

IInfec(doc clin or mibio) w/ Gr 3/4 neut-Catheter

Infec(doc clin or mibio) w/ Gr 3/4 neut-Eye NOS

Infec(doc clin or mibio) w/ Gr 3/4 neut-Lung

Infec(doc clin or mibio) w/ Gr 3/4 neut-Nose

Infec(doc clin or mibio) w/ Gr 3/4 neut-Pharynx

Infec(doc clin or mibio) w/ Gr 3/4 neut-Ur tract

Infec with nor ANC or Gr 1/2 neut-Lung (pneumonia)

Infection-Other (Specify)

Leukocytes (total WBC)

Lipase

Liver dysfunction/failure (clinical)

Lymphopenia

Magnesium, serum-high (hypermagnesemia)

Mucositis/stomatitis (clinical exam) - Oral cavity

Mucositis/stomatitis (funct/symp) - Oral cavity

Mucositis/stomatitis (func/symp) - Pharynx

Muscle weak,gen spec area-Whole body

Nausea

Neuropathy: motor

Neutrophils/granulocytes (ANC/AGC)

Pain - Abdomen NOS

Pain - Bone

Pain - Neck

Pancreatic endocrine: glucose intolerance

Pancreatitis

Phosphate, serum-low (hypophosphatemia)

Toxicity

Spots Global Cancer Trial Database for bactrim

Every month we try and update this database with for bactrim 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 bactrim

Every month we try and update this database with for bactrim 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 bactrim 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.