Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

NCT00016302 | Completed

• 4 other identifiers: NCI-2012-01857COG-AALL00P2U10CA098543CDR0000068620
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. This phase II trial is studying several different combination chemotherapy regimens to see how well they work in treating patients with newly diagnosed acute lymphoblastic leukemia

Conditions

T-cell Childhood Acute Lymphoblastic Leukemia; Untreated Childhood Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• Grade 3+ unusual CNS toxicities assessed using NCI CTCAE v. 3.0

  Up to 6 years

Study Arms (6)

Regimen A

EXPERIMENTAL

See detailed description.

Drug: prednisone; Drug: vincristine sulfate; Drug: daunorubicin hydrochloride; Drug: asparaginase; Drug: methotrexate; Drug: cyclophosphamide; Drug: cytarabine; Drug: mercaptopurine; Drug: leucovorin calcium; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: thioguanine; Radiation: radiation therapy; Other: pharmacological study; Other: laboratory biomarker analysis

Regimen B

EXPERIMENTAL

Induction (weeks 1-9): Patients receive treatment as in induction of regimen A. Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A. Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen A and nelarabine IV on days 162-166. Maintenance (weeks 30-101): Patients receive oral mercaptopurine daily on days 1-28 and 36-56; oral methotrexate weekly; and nelarabine IV on days 29-33. Treatment repeats every 8 weeks for 4 courses. Beginning on week 62, patients receive vincristine IV once; oral prednisone three times daily for 5 days; oral mercaptopurine daily; and oral methotrexate weekly. Treatment repeats every 8 weeks for 5 courses.

Drug: prednisone; Drug: vincristine sulfate; Drug: daunorubicin hydrochloride; Drug: asparaginase; Drug: methotrexate; Drug: cyclophosphamide; Drug: cytarabine; Drug: mercaptopurine; Drug: leucovorin calcium; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: thioguanine; Radiation: radiation therapy; Drug: nelarabine; Other: pharmacological study; Other: laboratory biomarker analysis

Regimen C

EXPERIMENTAL

Induction (weeks 1-5): Patients receive treatment as in induction (weeks 1-5) on regimen A and nelarabine IV over 1 hour on days 29-33. If bone marrow is M1, patients begin week 6 of induction therapy on day 36 or when peripheral blood counts recover. If bone marrow is M2, patients begin week 6 of induction therapy immediately. If bone marrow is M3, treatment discontinues. Induction (weeks 6-9): Patients receive treatment as in induction (weeks 6-9) on regimen A. Consolidation (weeks 10-19): Patients receive treatment as in consolidation on regimen A. Reinduction (weeks 20-29): Patients receive treatment as in reinduction on regimen B. Maintenance (weeks 30-101): Patients receive treatment as in maintenance on regimen B.

Drug: prednisone; Drug: vincristine sulfate; Drug: daunorubicin hydrochloride; Drug: asparaginase; Drug: methotrexate; Drug: cyclophosphamide; Drug: cytarabine; Drug: mercaptopurine; Drug: leucovorin calcium; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: thioguanine; Radiation: radiation therapy; Drug: nelarabine; Other: pharmacological study; Other: laboratory biomarker analysis

Regimen D

EXPERIMENTAL

See detailed description.

Drug: prednisone; Drug: vincristine sulfate; Drug: daunorubicin hydrochloride; Drug: asparaginase; Drug: methotrexate; Drug: cyclophosphamide; Drug: cytarabine; Drug: mercaptopurine; Drug: leucovorin calcium; Drug: dexamethasone; Drug: thioguanine; Drug: nelarabine; Drug: pegaspargase; Radiation: radiation therapy; Other: pharmacological study; Other: laboratory biomarker analysis

Regimen E

EXPERIMENTAL

Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen D, but nelarabine is administered at a higher dose.

Drug: prednisone; Drug: vincristine sulfate; Drug: daunorubicin hydrochloride; Drug: asparaginase; Drug: methotrexate; Drug: cyclophosphamide; Drug: cytarabine; Drug: mercaptopurine; Drug: leucovorin calcium; Drug: dexamethasone; Drug: thioguanine; Drug: nelarabine; Drug: pegaspargase; Radiation: radiation therapy; Other: pharmacological study; Other: laboratory biomarker analysis

Regimen F

EXPERIMENTAL

Patients receive nelarabine at a higher dose during induction therapy. Patients receive consolidation therapy, reinduction therapy, and maintenance therapy as in regimen E.

Drug: prednisone; Drug: vincristine sulfate; Drug: daunorubicin hydrochloride; Drug: asparaginase; Drug: methotrexate; Drug: cyclophosphamide; Drug: cytarabine; Drug: mercaptopurine; Drug: leucovorin calcium; Drug: dexamethasone; Drug: thioguanine; Drug: nelarabine; Drug: pegaspargase; Radiation: radiation therapy; Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

prednisone DRUG

Given orally

Also known as: DeCortin, Deltra

Regimen A; Regimen B; Regimen C; Regimen D; Regimen E; Regimen F

vincristine sulfate DRUG

Given IV

Also known as: leurocristine sulfate, VCR, Vincasar PFS

Regimen A; Regimen B; Regimen C; Regimen D; Regimen E; Regimen F

daunorubicin hydrochloride DRUG

Given IV

Also known as: Cerubidin, Cerubidine, daunomycin hydrochloride, daunorubicin, RP-13057

Regimen A; Regimen B; Regimen C; Regimen D; Regimen E; Regimen F

asparaginase DRUG

Given IM

Also known as: ASNase, Colaspase, Crasnitin, Elspar, L-ASP

Regimen A; Regimen B; Regimen C; Regimen D; Regimen E; Regimen F

methotrexate DRUG

Given IT and orally

Also known as: amethopterin, Folex, methylaminopterin, Mexate, MTX

Regimen A; Regimen B; Regimen C; Regimen D; Regimen E; Regimen F

cyclophosphamide DRUG

Given IV

Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana

Regimen A; Regimen B; Regimen C; Regimen D; Regimen E; Regimen F

cytarabine DRUG

Given IV or SC

Also known as: ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U, cytosine arabinoside

Regimen A; Regimen B; Regimen C; Regimen D; Regimen E; Regimen F

mercaptopurine DRUG

Given orally

Also known as: 6-mercaptopurine, 6-MP, Leukerin, MP

Regimen A; Regimen B; Regimen C; Regimen D; Regimen E; Regimen F

leucovorin calcium DRUG

Given IV or orally

Also known as: CF, CFR, LV

Regimen A; Regimen B; Regimen C; Regimen D; Regimen E; Regimen F

dexamethasone DRUG

Given orally

Also known as: Aeroseb-Dex, Decaderm, Decadron, DM, DXM

Regimen A; Regimen B; Regimen C; Regimen D; Regimen E; Regimen F

doxorubicin hydrochloride DRUG

Given IV

Also known as: ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF

Regimen A; Regimen B; Regimen C

thioguanine DRUG

Given orally

Also known as: 6-TG

Regimen A; Regimen B; Regimen C; Regimen D; Regimen E; Regimen F

radiation therapy RADIATION

Undergo cranial irradiation

Also known as: irradiation, radiotherapy, therapy, radiation

Regimen A; Regimen B; Regimen C

nelarabine DRUG

Given IV

Also known as: 506U78, Arranon, GW506U78

Regimen B; Regimen C; Regimen D; Regimen E; Regimen F

pegaspargase DRUG

Given IM

Also known as: L-asparaginase with polyethylene glycol, Oncaspar, PEG-ASP, PEG-L-asparaginase

Regimen D; Regimen E; Regimen F

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Regimen A; Regimen B; Regimen C; Regimen D; Regimen E; Regimen F

laboratory biomarker analysis OTHER

Correlative studies

Regimen A; Regimen B; Regimen C; Regimen D; Regimen E; Regimen F

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Newly diagnosed T-cell acute lymphoblastic leukemia with greater than 25%bone marrow blasts (M3)
• High-risk disease, defined as meeting at least 1 of the following criteria:
• WBC at least 50,000/mm\^3
• Age 10 years or over
• Patients with WBC at least 25,000/mm\^3 AND at least 50% peripheral blood blasts are eligible provided bone marrow aspiration was contraindicated (e.g., patient was not eligible for anesthesia or sedation due to respiratory distress secondary to anterior mediastinal mass)
• Concurrent registration to POG 9900 within the past 8 days required
• Performance status - Karnofsky 50-100% (over 10 years of age)
• Performance status - Lansky 50-100% (10 years of age and under)
• See Disease Characteristics
• Bilirubin no greater than 1.5 mg/dL
• SGPT less than 5 times normal
• Creatinine normal
• Creatinine clearance or glomerular filtration rate at least 60 mL/min
• No pre-existing neuropathy of grade 2 or worse unless due to leukemic infiltration
• Not pregnant or nursing

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

MeSH Terms

Interventions

Prednisone; Vincristine; Daunorubicin; Asparaginase; palmitoyl-L-asparaginase; Methotrexate; merphos; Cyclophosphamide; Cytarabine; Mercaptopurine; Leucovorin; Dexamethasone; Calcium Dobesilate; Doxorubicin; Thioguanine; Radiotherapy; Radiation; nelarabine; pegaspargase

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Aminoglycosides; Glycosides; Carbohydrates; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Aminopterin; Pterins; Pteridines; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Sulfhydryl Compounds; Sulfur Compounds; Purines; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Coenzymes; Pregnadienetriols; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Therapeutics; Physical Phenomena

Study Officials

• Kimberly Dunsmore

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2001
• First Posted: January 27, 2003
• Study Start: April 1, 2001
• Primary Completion: July 1, 2007
• Last Updated: January 16, 2013

Record last verified: 2013-01

Locations

US (1)