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Protocol Details

Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Adults and Children with Previously Untreated Patients with Aggressive Non-Hodgkin's Lymphoma

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

93-C-0133

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only
Gender: Male & Female
Min Age: 12
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Fetuses;
Pregnant Women

Keywords

Primary Mediastinal B-Cell Lymphoma;
CD20 +;
Diffuse Large B-Cell Lymphoma;
Anaplastic Large Cell Lymphoma;
De Novo

Recruitment Keyword(s)

None

Condition(s)

Diffuse Large B-Cell Lymphoma (DLBCL);
Primary Mediastinal Large B-cell Lymphoma;
Burkitt Lymphoma;
Anaplastic Large-Cell Lymphoma;
Gray Zone Lymphoma

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Drug: EPOCH
Biological/Vaccine: Rituximab

Supporting Site

National Cancer Institute

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.

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Eligibility

INCLUSION CRITERIA:

Non-Hodgkin's lymphomas in the following categories: mediastinal gray zone lymphoma and primary mediastinal B cell

lymphoma.

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: Any stage for MGZL and PMBL.

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 cancer.

Ability to give informed consent.


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Citations:

MACOP-B chemotherapy for the treatment of diffuse large-cell lymphoma

P-glycoprotein expression and schedule dependence of adriamycin cytotoxicity in human colon carcinoma cell lines

Advanced diffuse histiocytic lymphoma, a potentially curable disease

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Contacts:

Principal Investigator

Referral Contact

For more information:

Mark J. Roschewski, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CLINICAL CENTER BG RM 12C442
10 CENTER DR
BETHESDA MD 20892
(240) 760-6183
mark.roschewski@nih.gov

NCI Medical Oncology Referral Office
National Cancer Institute (NCI)

(888) 624-1937
ncimo_referrals@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT00001337

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