Clinical Trial: Combination Chemotherapy in Treating Children With Non-Hodgkin's Lymphoma

This study is no longer recruiting patients.

Sponsored by: United Kingdom Children's Cancer Study Group
Information provided by: National Cancer Institute (NCI)

Purpose

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. It is not yet known which combination chemotherapy regimen is more effective for non-Hodgkin's lymphoma. PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of combination chemotherapy in treating children who have newly diagnosed non-Hodgkin's lymphoma.

Condition Treatment or Intervention Phase
stage I childhood large cell lymphoma
stage III childhood lymphoblastic lymphoma
stage III childhood large cell lymphoma
stage IV childhood large cell lymphoma
stage IV childhood lymphoblastic lymphoma
stage II childhood large cell lymphoma
stage I childhood lymphoblastic lymphoma
stage II childhood lymphoblastic lymphoma
 Drug: asparaginase
 Drug: cyclophosphamide
 Drug: cytarabine
 Drug: daunorubicin
 Drug: dexamethasone
 Drug: etoposide
 Drug: mercaptopurine
 Drug: methotrexate
 Drug: prednisolone
 Drug: thioguanine
 Drug: vincristine
Phase III

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Lymphatic Diseases;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Study of Combination Chemotherapy for Children With Stages I-IV T-cell Non-Hodgkin's Lymphoma

Further Study Details: 

Study start: May 1995

OBJECTIVES: I. Determine whether event-free survival for children with T-cell non-Hodgkin's lymphoma (NHL) can be improved by the addition of a third intensification block at 35 weeks. II. Determine biology and treatment response of T-cell NHL and T-cell acute lymphocytic leukemia when both are treated with an identical leukemia type protocol and receive a third intensification block. III. Improve the outcome for the 25% of children who are not in remission at eight weeks by the addition of a block of sustained intensification before high dose methotrexate and continuing treatment.

PROTOCOL OUTLINE: Patients receive induction therapy on days 1-28. Patients receive supportive oral prednisolone daily for three doses during weeks 1-4, vincristine IV weekly for 5 weeks starting on day 1, asparaginase intramuscularly or subcutaneously three times a week beginning on day 4, and methotrexate intrathecally on days 1 and 8. Patients who meet certain criteria are given first intensification therapy beginning on day 29. Patients receive three doses of oral prednisolone, vincristine IV on day 1, daunorubicin IV over 6 hours on days 1 and 2, etoposide IV over 4 hours on days 1-5, cytarabine IV every 12 hours by bolus injection on days 1-5, oral thioguanine daily on days 1-5, and methotrexate intrathecally as in induction therapy. Patients are followed at 8 weeks. Those patients who experience remission receive a third intensification block at 35 weeks. All patients receive three methotrexate infusions followed by continuation therapy beginning at week 14. As continuation therapy, patients receive oral mercaptopurine daily, oral methotrexate weekly, vincristine IV every 4 weeks, oral prednisolone for 5 days every 4 weeks, and intrathecal methotrexate every 12 weeks beginning at week 23 until 100 weeks from the start of treatment. Continuation therapy will be interrupted at about week 20 for the second intensification therapy. For second intensification therapy, patients receive oral prednisolone daily for 5 days, a single dose of vincristine on day 1, daunorubicin IV over 6 hours on days 1 and 2, etoposide IV over 4 hours on days 1-5, bolus injections of cytarabine every 12 hours on days 1-5, oral thioguanine daily on days 1-5, and intrathecal methotrexate as in induction therapy. Continuation therapy re-starts at week 23. Patients who receive the third intensification therapy will begin at week 35. For the third intensification therapy, patients receive three doses of oral dexamethasone, IV vincristine on day 1 of weeks 35-38, subcutaneous asparaginase for 9 days during weeks 35-38, intrathecal methotrexate on day 1 of weeks 35 and 39, IV cyclophosphamide on day 1 of weeks 39 and 41, subcutaneous or IV cytarabine daily on days 1-4 of weeks 39- 42, and oral thioguanine daily during weeks 39-42. Continuation therapy re-starts at week 42/43. Some patients may receive radiotherapy during chemotherapy. Patients are followed every month for 1 year, every 2 months for the next year, every 6 months for the next 3 years, then annually thereafter.

PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study within 5 years.

Eligibility

Ages Eligible for Study:  up to  14 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • Newly diagnosed stage I, II, III, or IV T-cell non-Hodgkin's lymphoma
  • No T-cell large anaplastic, peripheral T-cell lymphomas, or T-cell lymphoblastic leukemia
  • No greater than 25% blasts in the bone marrow

--Prior/Concurrent Therapy--

  • No prior therapy

--Patient Characteristics--

  • Age: Under 15
  • Performance status: Not specified
  • Life expectancy: Not specified
  • Hematopoietic: Not specified
  • Hepatic: Not specified
  • Renal: Not specified

Location Information


United Kingdom, England
      Hospital for Sick Children NHS Trust, London,  England,  WC1N 3JH,  United Kingdom

Study chairs or principal investigators

Judith Mary Chessells,  Study Chair,  United Kingdom Children's Cancer Study Group   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000066443; UKCCSG-NHL-9503; EU-98012
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003423
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

Resources