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Combination Chemotherapy in Treating Children With Stage III or Stage IV Non-Hodgkin's Lymphoma or Acute Lymphoblastic Leukemia

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. Identifier: NCT00003217
Recruitment Status : Completed
First Posted : September 6, 2004
Last Update Posted : July 25, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

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 I trial to study the effectiveness of combination chemotherapy consisting of methotrexate and cyclophosphamide in treating children who have stage III or stage IV non-Hodgkin's lymphoma or acute lymphoblastic leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Biological: filgrastim Drug: cyclophosphamide Drug: cytarabine Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: methotrexate Drug: vincristine sulfate Phase 1

Detailed Description:

OBJECTIVES: I. Evaluate the feasibility and toxicity of dose intensification of methotrexate and cyclophosphamide in patients with stage III or IV small, noncleaved cell non-Hodgkin's lymphoma or B cell acute lymphoblastic leukemia. II. Estimate the response rate and survival of these patients after this therapy.

OUTLINE: This is a two-stage study. Patients will receive cytarabine either by continuous infusion (first stage) or bolus injection (second stage). Patients are stratified by disease (stage III non-Hodgkin's lymphoma (NHL) vs stage IV NHL vs stage B acute lymphoblastic leukemia). Therapy for all patients consists of alternating courses of "A" and "B". Patients with stage III disease receive 4 courses of chemotherapy (ABAB) while those with stage IV disease and B cell acute lymphoblastic leukemia receive 6 chemotherapy courses (ABABAB). Course A - Induction: Patients receive intrathecal methotrexate (IT MTX) and intrathecal cytarabine (IT Ara-C) on days 1, 4, and 11. Dexamethasone is administered by IV or orally twice a day on days 1-5. Cyclophosphamide IV is administered every 12 hours on days 1-3. Doxorubicin IV is administered over 15 minutes beginning 12 hours after the beginning of the 6th dose of cyclophosphamide (day 4). At the same time, vincristine IV is administered, then repeated on day 11. Patients begin filgrastim (granulocyte colony-stimulating factor; G-CSF) subcutaneously or IV over 30 minutes on day 5. Course B - Induction: The first 10 patients enrolled receive cytarabine by continuous infusion while the second 10 patients enrolled receive cytarabine by bolus IV. Patients begin treatment on day 18 and receive methotrexate IV over 24 hours plus IT MTX during hour 1. Dexamethasone is administered by IV or orally twice a day on days 1-5. After completing the 24 hour IV MTX infusion, patients begin cytarabine by continuous infusion over 48 hours or bolus IV every 12 hours for 4 doses. Patients receive G-CSF subcutaneously or IV over 30 minutes beginning on day 22. Patients are assessed for remission status before day 36. Course A - Consolidation: Patients receive dexamethasone IV or orally twice a day on days 1-5. IT MTX and IT Ara-C are administered on days 1 and 4. Cyclophosphamide is administered as during Induction, with vincristine IV and doxorubicin IV over 15 minutes 12 hours later. Vincristine repeats 1 week later. G-CSF administration begins on day 5. Course B - Consolidation: Therapy begins on day 22 with dexamethasone administered as previously. Methotrexate infusion and IT MTX are administered as in Course B - Induction, as is cytarabine (either as a continuous infusion or bolus IV). G-CSF is also administered as previously. Patients are followed monthly for the first 6 months, every 2 months for the next 6 months, then every 6 months for 3 years, then annually thereafter.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 16 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Dose Intensification of Methotrexate and Cyclophosphamide in Patients With Advanced-Stage (III/IV) Small Non-Cleaved Non-Hodgkins Lymphoma and B-Cell All- A Limited Institution Phase III Pilot Study
Study Start Date : March 1998
Actual Primary Completion Date : October 2004
Actual Study Completion Date : September 2006

Arm Intervention/treatment
Experimental: Treatment
See detailed description.
Biological: filgrastim
Other Names:
  • Granulocyte Colony-Stimulating Factor
  • r-metHuG-CSF
  • G-CSF
  • Neupogen
  • NSC #614629

Drug: cyclophosphamide
Other Names:
  • CTX
  • Cytoxan
  • NSC #26271
  • IND #7089

Drug: cytarabine
Other Names:
  • cytosine arabinoside
  • Ara-C
  • Cytosar
  • NSC #63878

Drug: dexamethasone
Other Names:
  • Decadron
  • NSC #034521

Drug: doxorubicin hydrochloride
Other Names:
  • Adriamycin
  • NSC #123127
  • IND #7038

Drug: methotrexate
Other Names:
  • MTX
  • amethopterin
  • NSC #740
  • IND #4291

Drug: vincristine sulfate
Other Names:
  • VCR
  • Oncovin
  • NSC #67574
  • IND #7161

Primary Outcome Measures :
  1. Event Free Survival

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Cytologically proven small, noncleaved cell non-Hodgkin's lymphoma, Burkitt's lymphoma, non-Burkitt's lymphoma, or B cell acute lymphoblastic leukemia (B-ALL) Stage III or IV B-ALL - must have FAB L3 morphology and have been registered on POG-9400

PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: HIV antibody positive allowed Not pregnant or lactating

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: Prior emergency steroid therapy may be allowed Radiotherapy: Prior emergency radiotherapy may be allowed Surgery: Prior surgery allowed Other: No concurrent dexamethasone as an anti-emetic

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003217

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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States, 94304
United States, Illinois
Children's Memorial Hospital, Chicago
Chicago, Illinois, United States, 60614
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
University of Rochester Cancer Center
Rochester, New York, United States, 14642
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
United States, Oklahoma
Oklahoma Memorial Hospital
Oklahoma City, Oklahoma, United States, 73126-0307
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
United States, Texas
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States, 76104
United States, Wisconsin
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States, 53226
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T2T 5C7
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
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Study Chair: Timothy C. Griffin, MD Cook Children's Medical Center - Fort Worth
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Responsible Party: Children's Oncology Group Identifier: NCT00003217    
Other Study ID Numbers: 9517
POG-9517 ( Other Identifier: Pediatric Oncology Group )
CDR0000066078 ( Other Identifier: Clinical )
First Posted: September 6, 2004    Key Record Dates
Last Update Posted: July 25, 2014
Last Verified: July 2014
Keywords provided by Children's Oncology Group:
childhood Burkitt lymphoma
untreated childhood acute lymphoblastic leukemia
B-cell childhood acute lymphoblastic leukemia
stage III childhood small noncleaved cell lymphoma
stage IV childhood small noncleaved cell lymphoma
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents