Bone Marrow/bone Marrow Transplantation |
Bone Marrow Transplant; Bone Marrow Transplantation |
Clinical Trial: Chemotherapy and Radiation Therapy Plus Bone Marrow Transplantation in Treating Patients With Aggressive Non-Hodgkin's Lymphoma
This study is no longer recruiting patients.
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Bone marrow transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Randomized phase III trial to study the effectiveness of chemotherapy and radiation therapy plus bone marrow transplantation in treating patients who have aggressive non-Hodgkin's lymphoma.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| adult non-Hodgkin's lymphoma | Drug: bleomycin Drug: carmustine Drug: cyclophosphamide Drug: cytarabine Drug: doxorubicin Drug: etoposide Drug: melphalan Drug: prednisolone Drug: vincristine Procedure: autologous bone marrow transplantation Procedure: biological response modifier therapy Procedure: bone marrow ablation with stem cell support Procedure: bone marrow transplantation Procedure: chemotherapy Procedure: radiation therapy | Phase III |
MedlinePlus related topics: Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of High-Dose Chemotherapy and Radiotherapy Plus Autologous Bone Marrow Transplantation in Patients With Aggressive Non-Hodgkin's Lymphoma
OBJECTIVES:
- Assess the rate of remission in patients with aggressive non-Hodgkin's lymphoma treated with high-dose chemotherapy and radiotherapy plus autologous bone marrow transplantation.
- Determine the efficacy and toxic effects of this regimen in these patients.
OUTLINE: This is a randomized, placebo-controlled, multicenter study. Patients are stratified according to risk group (good vs intermediate vs poor).
Patients undergo harvest of autologous bone marrow stem cells after priming chemotherapy and before transplantation.
Patients receive induction chemotherapy comprising the CHOP or VAPEC-B regimen. The CHOP regimen consists of vincristine (VCR) IV, cyclophosphamide (CTX) IV, and doxorubicin (DOX) IV on day 1 and oral prednisolone (PRDL) on days 1-5. Treatment repeats every 3 weeks for six courses. The VAPEC-B regimen consists of DOX IV on days 1, 15, 29, 43, 57, and 71; CTX IV on days 1, 29, and 57; VCR IV on days 8, 22, 36, 50, and 64; bleomycin IV on days 8, 36, 64; oral etoposide (VP-16) on days 15-19, 43-47, and 71-75; and oral PRDL daily for 13 weeks.
Patients then may undergo radiotherapy for 2-3 weeks to areas of original bulk or residual disease.
- Patients are randomized to one of two treatment arms.
- Arm I: Patients receive no further treatment.
- Arm II: Patients receive melphalan (L-PAM) before or after total body irradiation (TBI), which is delivered in 3 fractions over 24 hours. After completion of radiotherapy, patients undergo autologous bone marrow transplantation (AuBMT).
- Patients are randomized one of three treatment arms.
- Arm III: Patients receive L-PAM IV on day -2 and AuBMT on day 0.
- Arm IV: Patients receive treatment as in arm II.
- Arm V: Patients receive carmustine IV on day -6, VP-16 IV once daily and cytarabine IV twice daily on days -5 to -2, and L-PAM IV on day -1. Radiotherapy to bulk disease begins after completion of chemotherapy. Patients undergo AuBMT on day 0. Patients are followed monthly for 3 months, every 2 months for 1 year, every 4 months for 2 years, and then every 6 months thereafter.
PROJECTED ACCRUAL: Not specified
Eligibility
Ages Eligible for Study: 15 Years - 65 Years, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed aggressive non-Hodgkin's lymphoma requiring chemotherapy
- Stage II, III, or IV
- B cell:
- Centroblastic
- Immunoblastic
- Large cell anaplastic
- Non-Burkitt lymphoblastic
- T cell:
- Pleomorphic medium cell
- Pleomorphic large cell
- Immunoblastic
- Large cell anaplastic
- Lymphoblastic
- No Burkitt (L3) subtype
- No large mediastinal mass OR
- Stage I, II, III, or IV
- Bulk disease greater than 10 cm
- Nodal or extranodal site
- No primary localized gut lymphoma
- No CNS involvement
PATIENT CHARACTERISTICS:
Age:
- 15 to 65
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- No concurrent bone marrow dysplastic syndromes
Hepatic:
- Bilirubin no greater than 2.5 times upper limit of normal (ULN)
Renal:
- Creatinine no greater than 2.5 times ULN
Other:
- No other malignancy except skin cancer or stage I cervical cancer
- Not pregnant
PRIOR CONCURRENT THERAPY: Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Location Information
United Kingdom, England
Newcastle Upon Tyne Hospitals NHS Trust, Newcastle upon Tyne, England, NE1 4LP, United Kingdom
Stephen J. Proctor, MD, Study Chair, Newcastle Upon Tyne Hospitals NHS Trust
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: September 2003
Last Updated: October 13, 2004
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00003815
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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