Combination Chemotherapy in Treating Children With Lymphoma
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: filgrastim Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: doxorubicin hydrochloride Drug: etoposide Drug: leucovorin calcium Drug: methotrexate Drug: pegaspargase Drug: prednisone Drug: thioguanine Drug: vincristine sulfate Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A PILOT STUDY FOR THE TREATMENT OF NEWLY-DIAGNOSED DISSEMINATED LYMPHOBLASTIC LYMPHOMA |
| Estimated Enrollment: | 90 |
| Study Start Date: | July 1994 |
OBJECTIVES: I. Estimate the toxicity and feasibility of intensifying the New York I (NYI) regimen by adding etoposide and cytarabine, increasing the dose of methotrexate, using pegaspargase, and compressing the treatment duration (11 months) in previously untreated children with disseminated anaplastic (Ki-1 positive) large cell and large cell T-cell lymphoma. II. Provide preliminary data for a future phase III study that will compare this intensified regimen with the high-risk ALL regimen NYI in children with disseminated lymphoblastic lymphoma. III. Continue to investigate the immunophenotype, cytogenetics, and molecular biology of lymphoblastic lymphoma and their relationship to leukemia. IV. Obtain preliminary data on treatment of anaplastic large cell (Ki-1) and T-cell large cell lymphoma treated with intensive NYI.
OUTLINE: Patients with CNS disease at diagnosis receive craniospinal irradiation on Regimen A at the conclusion of Maintenance chemotherapy. The following acronyms are used: ARA-C Cytarabine, NSC-63878 CF Leucovorin calcium, NSC-3590 CTX Cyclophosphamide, NSC-26271 DNR Daunorubicin, NSC-82151 DOX Doxorubicin, NSC-123127 G-CSF Granulocyte Colony-Stimulating Factor (Amgen), NSC-614629 MTX Methotrexate, NSC-740 PEG-ASP Pegaspargase, NSC-624239 PRED Prednisone, NSC-10023 TG Thioguanine, NSC-752 VCR Vincristine, NSC-67574 VP-16 Etoposide, NSC-141540 Induction: 5-Drug Combination Systemic Chemotherapy with Hematopoietic Stimulation plus 2-Drug Combination Intrathecal Chemotherapy. VCR/PRED/CTX/DNR/PEG-ASP; with G-CSF; plus IT ARA-C/IT MTX. Consolidation: 7-Drug Combination Systemic Chemotherapy with Hematopoietic Stimulation plus Single-Agent Intrathecal Chemotherapy. VCR/PRED/PEG-ASP/VP-16/TG/ARA-C/MTX/CF; with G-CSF; plus IT MTX. Maintenance: Sequential Pulses of 2-, 3-, 3-, and 2-Drug Systemic Chemotherapy Combinations plus Single-Agent Intrathecal Chemotherapy. CTX/TG/IT MTX; VCR/PRED/DOX; VCR/MTX/CF/PEG-ASP; ARA-C/VP-16. Regimen A: Radiotherapy. Craniospinal irradiation using megavoltage equipment.
PROJECTED ACCRUAL: 40 patients will be entered over approximately 10 months. If 4 or more toxic deaths occur in the first 15 patients or 5 or more toxic deaths occur in the first 30 patients, accrual will stop. As of 05/96, asparaginase has been replaced with pegaspargase; 15-25 additional patients will be accrued. As of 01/97, a maximum of 35 patients will be accrued for PEG asparaginase-containing treatment regimen. As of 5/97, this study is open only to patients with anaplastic large cell and T cell large cell lymphoma. Approximately 60-90 patients will be accrued.
Eligibility| Ages Eligible for Study: | up to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed and previously untreated anaplastic large cell Ki-1 lymphoma and T-cell large cell lymphoma Malignant lymphoblasts (identified by immunophenotype) in pleural fluid, ascitic fluid, or bone marrow sufficient for diagnosis Large cell lymphoma with T-cell phenotype eligible Localized mediastinal disease and bone lymphoma eligible CNS disease eligible and defined as: Any clearly identifiable tumor cells in cerebral spinal fluid Cranial nerve palsy (if not explained by extra cranial tumor) Clinical Spinal Cord Compression Isolated intra cerebral mass No cranial nerve palsies requiring immediate CNS irradiation
PATIENT CHARACTERISTICS: Age: Under 21 Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: Shortening fraction greater than 27% on echocardiogram (ECHO) OR Left ventricular ejection fraction greater than 47% on radionuclide scan (RCNA) OR Cardiac function assessed as within normal limits by cardiologist ECHO or RCNA obtained as close as clinically possible to start of therapy
PRIOR CONCURRENT THERAPY: No prior therapy except emergency treatment of airway obstruction or superior vena cava syndrome No more than 72 hours between emergency radiotherapy or steroids and initiation of protocol therapy
Contacts and Locations
Show 33 Study Locations| Study Chair: | Minnie Abromowitch, MD | Children's Hospital Medical Center, Cincinnati |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00002590 History of Changes |
| Other Study ID Numbers: | CDR0000063751, CCG-5941 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 21, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV childhood lymphoblastic lymphoma stage IV childhood large cell lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, Lymphoid Leukemia Cyclophosphamide Cytarabine Methotrexate Pegaspargase Daunorubicin |
Doxorubicin Etoposide Prednisone Thioguanine Vincristine Lenograstim Leucovorin Levoleucovorin Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating |
ClinicalTrials.gov processed this record on May 21, 2013