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Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005977
First Posted: May 21, 2003
Last Update Posted: August 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
July 5, 2000
May 21, 2003
August 21, 2013
September 2000
March 2004   (Final data collection date for primary outcome measure)
Event-free survival [ Time Frame: 1 year ]
Assess the effect of high dose methotrexate in combination with standard treatment per the POG 9317 protocol on 1-year event-free survival (EFS), monitor and assess toxicity, and estimate the hospitalization costs for the treatment of toxicity related side effects.
Not Provided
Complete list of historical versions of study NCT00005977 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Combination Chemotherapy in Treating Patients With Non-Hodgkin's Lymphoma or Acute Lymphocytic Leukemia
A Pilot Study of Dose Intensification of Methotrexate in Patients With Advanced-Stage (III/IV) Small Non-Cleaved Cell Non-Hodgkins Lymphoma and B-Cell All

RATIONALE: 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.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have non-Hodgkin's lymphoma or acute lymphocytic leukemia.

OBJECTIVES:

  • Determine if increasing the methotrexate dose in combination with standard treatment is feasible in patients with advanced small noncleaved cell non-Hodgkin's lymphoma or B-cell acute lymphocytic leukemia.
  • Assess the toxicity of this intensified therapy in these patients.
  • Assess the feasibility of treating these patients that have CNS disease at diagnosis with this intensified therapy plus etoposide and ifosfamide.
  • Assess toxicities and late effects of this intensive therapy on the central nervous system, cardiac function, and fertility in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to stage and disease (stage III non-Hodgkin's lymphoma (NHL) vs stage IV NHL with no CNS involvement vs stage IV NHL with CNS involvement vs B-cell acute lymphocytic leukemia (B-ALL) with no CNS involvement vs B-ALL with CNS involvement).

Patients receive methotrexate and cytarabine intrathecally on days 1, 4, 11, and 36 (on day 40 for patients with stage IV NHL or B-ALL only) in combination with alternating courses of: A) cyclophosphamide IV every 12 hours for a total of six doses on days 1-3, doxorubicin IV over 30 minutes on day 4, vincristine IV on days 4 and 11, dexamethasone IV or orally twice daily on days 1-5, and filgrastim (G-CSF) subcutaneously (SQ) or IV over 30 minutes beginning on day 5 and continuing until blood counts recover and B) methotrexate IV over 24 hours on day 18, methotrexate intrathecally on day 18, dexamethasone IV or orally twice daily on days 18-22, leucovorin calcium IV or orally every 6 hours for a total of 6 doses on days 20-21, cytarabine IV over 48 hours on days 20-21, and G-CSF SQ or IV over 30 minutes beginning on day 22 and continuing until blood counts recover. Patients with stage III NHL receive at total of 5 courses of treatment (A-B-A-B-A) and patients with stage IV NHL or B-ALL with no CNS involvement receive a total of 6 courses of treatment (A-B-A-B-A-B).

Patients with CNS involvement receive a third course of treatment: C) etoposide IV over 1 hour on days 36-40, ifosfamide IV over 1 hour on days 36-40, oral dexamethasone twice daily on days 36-40, and G-CSF SQ or IV over 30 minutes beginning on day 41 and continuing until blood counts recover. Patients with CNS involvement receive a total of 7 courses of treatment (A-B-C-A-B-A-B).

Patients are followed every 6 months for 4 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 27-80 patients will be accrued for this study over 24 months.

Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Leukemia
  • Lymphoma
  • Biological: filgrastim
    Given IV
    Other Names:
    • GRANULOCYTE COLONY-STIMULATING FACTOR
    • r-metHuG-CSF
    • G-CSF
    • Neupogen
    • NSC #614629
  • Drug: cyclophosphamide
    Given IV
    Other Names:
    • CTX
    • Cytoxan
    • NSC #26271
    • IND #7089
  • Drug: cytarabine
    Given IV
    Other Names:
    • cytosine arabinoside
    • Ara-C
    • Cytosar
    • NSC #638
  • Drug: dexamethasone
    Given IV
    Other Names:
    • DECADRON
    • NSC #034521
  • Drug: doxorubicin hydrochloride
    Given IV
    Other Names:
    • Adriamycin
    • NSC #123127
    • IND #7038
  • Drug: etoposide
    Given IV
    Other Names:
    • VP-16
    • VePesid
    • NSC #141540
    • IND #9197
  • Drug: ifosfamide
    Given IV
    Other Names:
    • IFX
    • IFOS
    • NSC #109724
    • IND #7887
  • Drug: leucovorin calcium
    Given IV
    Other Names:
    • LCV
    • Wellcovorin
    • citrovorum factor
    • folinic acid
    • NSC #3590
  • Drug: methotrexate
    Given IV
    Other Names:
    • MTX
    • amethopterin
    • NSC #740
    • IND #4291
  • Drug: vincristine sulfate
    Given IV
    Other Names:
    • VCR
    • Oncovin
    • NSC #67574
    • IND #7161
  • Experimental: STAGE III NHL (Trt 1)

    A: Cyclophosphamide (CTX), Doxorubicin hydrochloride, Vincristine sulfate (VCR), Dexamethasone IT Therapy. B: HD-Methotrexate(MTX), Cytarabine(Ara-C), Dexamethasone IT Therapy.

    Treatment ABABA

    Interventions:
    • Biological: filgrastim
    • Drug: cyclophosphamide
    • Drug: cytarabine
    • Drug: dexamethasone
    • Drug: doxorubicin hydrochloride
    • Drug: leucovorin calcium
    • Drug: methotrexate
    • Drug: vincristine sulfate
  • Experimental: STAGE IV NHL, -CNS (Trt 2)

    A: Cyclophosphamide (CTX), Doxorubicin hydrochloride, Vincristine sulfate (VCR), Dexamethasone IT Therapy. B: HD-Methotrexate(MTX), Cytarabine(Ara-C), Dexamethasone IT Therapy.

    Treatment ABABAB

    Interventions:
    • Biological: filgrastim
    • Drug: cyclophosphamide
    • Drug: cytarabine
    • Drug: dexamethasone
    • Drug: doxorubicin hydrochloride
    • Drug: leucovorin calcium
    • Drug: methotrexate
    • Drug: vincristine sulfate
  • Experimental: STAGE IV, +CNS (Trt 3)

    A: Cyclophosphamide (CTX), Doxorubicin hydrochloride, Vincristine sulfate (VCR), Dexamethasone IT Therapy. B: HD-Methotrexate(MTX), Cytarabine(Ara-C), Dexamethasone IT Therapy. C: Etoposide, Ifosfamide, Dexamethasone IT Therapy.

    Treatment ABCABAB

    Interventions:
    • Biological: filgrastim
    • Drug: cyclophosphamide
    • Drug: cytarabine
    • Drug: dexamethasone
    • Drug: doxorubicin hydrochloride
    • Drug: etoposide
    • Drug: ifosfamide
    • Drug: leucovorin calcium
    • Drug: methotrexate
    • Drug: vincristine sulfate
  • Experimental: B-ALL, -CNS (Trt 2)

    A: Cyclophosphamide (CTX), Doxorubicin hydrochloride, Vincristine sulfate (VCR), Dexamethasone IT Therapy. B: HD-Methotrexate(MTX), Cytarabine(Ara-C), Dexamethasone IT Therapy.

    Treatment ABABAB

    Interventions:
    • Biological: filgrastim
    • Drug: cyclophosphamide
    • Drug: cytarabine
    • Drug: dexamethasone
    • Drug: doxorubicin hydrochloride
    • Drug: leucovorin calcium
    • Drug: methotrexate
    • Drug: vincristine sulfate
  • Experimental: B-ALL, +CNS (Trt 3)

    A: Cyclophosphamide (CTX), Doxorubicin hydrochloride, Vincristine sulfate (VCR), Dexamethasone IT Therapy. B: HD-Methotrexate(MTX), Cytarabine(Ara-C), Dexamethasone IT Therapy. C: Etoposide, Ifosfamide, Dexamethasone IT Therapy.

    Treatment ABCABAB

    Interventions:
    • Biological: filgrastim
    • Drug: cyclophosphamide
    • Drug: cytarabine
    • Drug: dexamethasone
    • Drug: doxorubicin hydrochloride
    • Drug: etoposide
    • Drug: ifosfamide
    • Drug: leucovorin calcium
    • Drug: methotrexate
    • Drug: vincristine sulfate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
September 2006
March 2004   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • One of the following diagnoses:

    • Histologically confirmed small noncleaved cell non-Hodgkin's lymphoma

      • Stage III or IV
      • Burkitt's or non-Burkitt's by the Working Formulation OR
      • Burkitt's or Burkitt's-like by the REAL classification
    • Histologically confirmed B-cell acute lymphocytic leukemia

      • At least 25% blasts in bone marrow
      • FAB L3 morphology
      • FAB L1 morphology allowed if blasts show B-cell markers (CD19, 20, 22) and surface immunoglobulin positivity
      • Must be registered on POG-9900 in past 8 days

PATIENT CHARACTERISTICS:

Age:

  • Under 22 at time of diagnosis

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • HIV positive allowed

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • No concurrent use of dexamethasone as antiemetic

Radiotherapy:

  • Not specified

Surgery:

  • Prior surgery allowed

Other:

  • No prior therapy except surgery
Sexes Eligible for Study: All
up to 22 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Netherlands,   Puerto Rico,   Switzerland,   United States
 
 
NCT00005977
9917
COG-9917 ( Other Identifier: Children's Oncology Group )
CDR0000067965 ( Other Identifier: Clinical Trials.gov )
Yes
Not Provided
Not Provided
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Hazem H. Mahmoud, MD Carol G. Simon Cancer Center at Morristown Memorial Hospital
Children's Oncology Group
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP