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	Maintenance Rituximab for Follicular Lymphoma Azacitidine Improves Survival in MDS Second Stem Cell Transplant Not Helpful in Myeloma

Phase II Chemotherapy with MTX/CF, Aminopterin or M-BACOD plus CTX or BCG Immunotherapy for Advanced non-Hodgkin's Lymphoma

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III, Phase II Treatment Closed 25 to 65 DFCI-75116

Objectives

I.  Determine the objective response rate with high-dose MTX/CF rescue in a 
pilot group of patients with advanced non-Hodgkin's lymphoma.
II.  Determine whether a high response rate can be achieved with M-BACOD 
(methotrexate, bleomycin, adriamycin, cyclophosphamide, vincristine, 
dexamethasone) but with less toxicity (especially pulmonary) compared to BACOP.
III.  Determine whether an improved remission duration and survival can be 
achieved by decrease in relapse rate (especially CNS).
IV.  Characterize malignant lymphocyte clones and evaluate immunologic status 
prior to, during, and after M-BACOD.
V.  Develop immunotherapy programs in patients where tumor has been 
cryopreserved.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically proven 
non-Hodgkin's lymphoma, classified according to Rappaport's criteria.  
Eligible types and stages are those with favorable (nodular) histology, Stage 
IV (extensive to liver, bone marrow or other extranodal sites) and those with 
unfavorable (diffuse) histology, Stage II (extension below the diaphragm or 
with extranodal sites) or Stages III or IV.  Patients must be between 25 and 
65 years of age.  Patients eligible for the MTX/CF pilot study must have 
measurable disease and a creatinine clearance of at least 60 cc/min.

Expected Enrollment

30-40 patients/year will be entered.  Study closed.

Outline

Randomized study.
Part I:  Nonrandomized Pilot study.
Single-agent Chemotherapy plus Rescue.  Methotrexate, MTX, NSC-740; Citrovorum 
factor, CF, NSC-3590; if no response, substitute Aminopterin, NSC-739.
Part II:  Nonrandomized study.
6-Drug Combination Chemotherapy and Hormone Therapy.  MTX; CF; plus Bleomycin, 
BLEO, NSC-125066; Adriamycin, ADR, NSC-123127; Cyclophosphamide, CTX, 
NSC-26271; Dexamethasone, DM, NSC-34521; plus Vincristine, VCR, NSC-67574.
Part III:  Randomized study.
Arm I:  Immunotherapy.  BCG - type not given.
Arm II:  Single-agent Chemotherapy.  CTX.
Arm III:  No further therapy.

Trial Contact Information

Trial Lead Organizations

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Emil Frei, MD, Protocol chair(Contact information may not be current)
Ph: 617-632-3474; 866-790-4500

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.