Trial record 1 of 1 for:    NCT00001337
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Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin's Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT00001337
First received: November 3, 1999
Last updated: March 14, 2014
Last verified: March 2014
  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
Drug: EPOCH-R
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)
Arms Assigned Interventions
Experimental: Arm A
Combination chemotherapy
Drug: EPOCH-R
Combination chemotherapy--EPOCH-R given IV over 5 days every 3 weeks for 6 cycles.

  Hide Detailed Description

Detailed Description:

Background:

The treatment of the intermediate and aggressive non-Hodgkin's lymphomas in adults and children commonly induces complete responses in a sizable fraction of the treated population, and about 2/3 of the complete responders appear to have prolonged disease-free survival.

The present study assesses the activity and tolerability in previously untreated patients of a regimen of EPOCH infusional chemotherapy given intensively with G-CSF support.

Objectives:

Primary:

Assess complete response (CR) and progression-free survival (PFS) of dose-adjusted EPOCH-Rituximab (DA-EPOCH-R) with G-CSF in agressive B-cell lymphomas.

Secondary:

Assess PFS in bcl-2 + lymphomas treated with dose-adjusted EPOCH-R, and determine if it is significantly better than dose-adjusted EPOCH alone.

Obtain pilot information on the CR and PFS of dose-adjusted EPOCH with G-CSF in CD20 negative B cell lymphomas, anaplastic large cell lymphomas (ALCL) and peripheral T-cell lymphomas (PTCL).

Assess toxicity of dose-adjusted EPOCH-Rituximab with G-CSF in agressive lymphomas.

Characterize the patterns of mdr-1, bcl-2, MIB-1 and mutant p53 expression in previously untreated lymphoma patients.

Assess the effect of EPOCH-R on ovarian function and reserve in female patients with PMBL.

Eligibility:

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, aggressive

T-cell lymphomas and Burkitt Lymphoma.

Patients greater than or equal to 12 years old.

Stages II, III, IV for all subtypes, and Stage I for bulky (> 5 cm) primary mediastinal

lymphomas or Burkitt Lymphoma.

No prior systemic chemotherapy.

HIV negative.

Design:

This study will estimate the complete response rate of a group of previously untreated patients and the extent to which EPOCH infusional drug delivery accompanied by a hematopoietic growth factor can increase the dose intensity of treatment.

Patients receive prednisone orally for 5 days, a 96 hour infusion of vincristine, doxorubicin, and etoposide, and a bolus of cyclophosphamide on day 5.

Cycles are repeated every 21 days for a total of 6-8 cycles.

Patients with CD20 expressing tumors (i.e. mature B-cell lymphomas) will also receive rituximab, the humanized monoclonal antibody against the CD20 receptor on day 1 of each cycle.

A total of 318 patients will be enrolled on this protocol.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001337

Contacts
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

Locations
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      
Sponsors and Collaborators
Investigators
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: March 14, 2014
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
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 23, 2014