Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma
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Purpose
5-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation. EPOCH: Etoposide, VP-16, NSC-141540; Prednisone, PRED, NSC-10023; Vincristine, VCR, NSC-67574; Cyclophosphamide, CTX, NSC-26271; Doxorubicin, DOX, NSC-123127; with Granulocyte Colony-Stimulating Factor (Amgen), G-CSF, NSC-614629.
| Condition | Intervention | Phase |
|---|---|---|
|
Non Hodgkin's Lymphoma |
Biological: filgrastim Biological: Rituximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Adults and Children With Previously Untreated Patients With Aggressive Non-Hodgkin's Lymphoma |
- Complete response after completion of study treatment [ Designated as safety issue: No ]
- Progression-free survival 5 years after completion of study treatment [ Designated as safety issue: No ]
- Toxicity during treatment [ Designated as safety issue: Yes ]
- Patterns of mdr-1. bcl-2, MIB-1, and mutant p53 expression in untreated lymphomas at completion of study treatment [ Designated as safety issue: No ]
| Estimated Enrollment: | 318 |
| Study Start Date: | April 1993 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
-
Biological: filgrastim
Show Detailed Description Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
Non-Hodgkin's lymphomas in the following categories: diffuse large B cell to include gray zone lymphoma and follicular center cell grade IIIB, anaplastic large cell, and aggressive T-cell lymphomas and Burkitt Lymphoma.
Patients with evidence of an underlying low-grade lymphoma will not be eligible for this study. This includes patients who have both indolent and aggressive histologies in the same or different biopsy sites (e.g. large cell lymphoma in a node and follicular center cell lymphoma in the bone marrow).
Diagnosis confirmed by staff of the Hematopathology Section, Laboratory of Pathology, NCI. Tissue blocks from patients treated in extramural sites must be forwarded to the NCI for analysis of bcl-2 by IHC and other markers within 1 month of study entry.
Patients greater than or equal to 12 years old.
Stage and Prognosis of Patients: Stages II, III, IV for all subtypes, and stage I bulky (greater than 5 cm) primary mediastinal B-cell lymphomas or Burkitt Lymphoma.
No prior systemic chemotherapy. Patients may be entered if they have had prior limited-field radiotherapy, a short course of glucocorticoids and/or cyclophosphamide for an urgent problem at diagnosis (e.g. epidural cord compression, superior vena cava syndrome).
HIV negative.
Not pregnant or nursing.
Adequate major organ function [in adults: serum creatinine less than or equal to 1.5 mg/dl or creatinine clearance greater than 60 ml/min; and in children serum CR less than or equal to age-adjusted normal (age 12 to 15 maximum serum creatinine 1.2 mg/dl and age greater than 15 maximum serum creatinine 1.5 mg/dl); bilirubin less than 1.5 mg/dl; ANC greater than 1,000 and platelets greater than 100,000) unless impairment is due to organ involvement by lymphoma or immune-mediated mechanism caused by lymphoma.
No active symptomatic ischemic heart disease, myocardial infarction or congestive heart failure within the past year. If MUGA is obtained, the LVEF should exceed 40%.
No other serious concomitant medical illnesses or uncontrolled active infection that would jeopardize the patient's ability to receive the regimen with reasonable safety.
No history of unrelated (non-lymphomatous) neoplasms within past 5 years other than non-melanoma skin cancer or in-situ cervix cancer.
Ability to give informed consent.
Contacts and Locations| Contact: Margaret Shovlin, R.N. | (301) 594-6597 | mshovlin@mail.nih.gov |
| Contact: Wyndham H Wilson, M.D. | (301) 435-2415 | wilsonw@mail.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office (888) NCI-1937 | |
| Principal Investigator: | Wyndham H Wilson, M.D. | National Cancer Institute (NCI) |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ) |
| ClinicalTrials.gov Identifier: | NCT00001337 History of Changes |
| Obsolete Identifiers: | NCT00018980 |
| Other Study ID Numbers: | 930133, 93-C-0133 |
| Study First Received: | November 3, 1999 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Open-Label Non-Randomized Pilot Primary Mediastinal B-Cell Lymphoma |
CD20 + Diffuse Large B-Cell Lymphoma Anaplastic Large Cell Lymphoma De Novo |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lenograstim |
Rituximab Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 16, 2013