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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002835 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy in treating patients who have intermediate-grade or immunoblastic lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: bleomycin sulfate Biological: filgrastim Biological: recombinant interferon alfa Drug: carmustine Drug: cisplatin Drug: cyclophosphamide Drug: cytarabine Drug: etoposide Drug: idarubicin Drug: ifosfamide Drug: leucovorin calcium Drug: melphalan Drug: methotrexate Drug: methylprednisolone Drug: mitoxantrone hydrochloride Drug: vincristine sulfate Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A RANDOMIZED PROSPECTIVE STUDY OF EARLY INTENSIFICATION VS ALTERNATING TRIPLE THERAPY FOR PATIENTS WITH POOR PROGNOSIS LYMPHOMA |
Eligibility| Ages Eligible for Study: | 15 Years to 59 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of previously untreated intermediate-grade or immunoblastic lymphoma
Tumor score of 3 or greater, defined by the presence of 3 or more of the following criteria :
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| United States, Texas | |
| University of Texas - MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Richard E. Champlin, MD | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | CDR0000065044, MDA-DM-95121, NCI-V96-1010 |
| Study First Received: | November 1, 1999 |
| Last Updated: | April 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002835 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I grade 3 follicular lymphoma stage I adult diffuse small cleaved cell lymphoma stage I adult diffuse mixed cell lymphoma stage I adult diffuse large cell lymphoma stage I adult immunoblastic large cell lymphoma stage III grade 3 follicular lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse large cell lymphoma stage III adult immunoblastic large cell lymphoma stage IV grade 3 follicular lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult diffuse mixed cell lymphoma |
stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma contiguous stage II grade 3 follicular lymphoma contiguous stage II adult diffuse small cleaved cell lymphoma contiguous stage II adult diffuse mixed cell lymphoma contiguous stage II adult immunoblastic large cell lymphoma contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II grade 3 follicular lymphoma noncontiguous stage II adult diffuse small cleaved cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma |
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Anti-Inflammatory Agents Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Therapeutic Uses Abortifacient Agents Methotrexate Angiogenesis Modulating Agents Dermatologic Agents Etoposide |
Nucleic Acid Synthesis Inhibitors Methylprednisolone Hemisuccinate Immunoproliferative Disorders Antineoplastic Agents, Hormonal Immune System Diseases Carmustine Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Idarubicin Neoplasms Mitoxantrone Interferon Alfa-2a Lymphoma, Non-Hodgkin Antineoplastic Agents, Phytogenic |