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A 60-patient phase II study was conducted to determine the safety and efficacy of retreatment with the anti-CD20 monoclonal antibody (MoAb) rituximab (Rituxan) in patients with low-grade or follicular non-Hodgkin’s lymphoma (NHL). Patients were relapsed or refractory to prior chemotherapy but had previously responded to rituximab. Upon progression of disease, patients received IV infusions of rituximab at 375 mg/m² weekly × 4. Patient characteristics were 55% males with medians of: age, 56 years; three prior therapies; 14.2 months since last treatment; and 4.7 years since diagnosis.

MIAMI BEACH-Patients with hematologic malignancies and high circulating lymphocyte counts are at increased risk for infusion-related side effects after the initial infusion of the anti-CD20 mo-noclonal antibody rituximab (Rituxan), but this problem can be prevented by a stepped-dosing scheme.

There are standard response criteria for solid tumors, chronic lymphocytic leukemia, Hodgkin’s disease, and acute myelogenous

WASHINGTON-Medicare will phase in a new payment method for managed care groups, known as risk adjustment, over the first 5 years of the new century. The payment plan, required under the Balanced Budget Act of 1997, is intended to encourage managed care organizations to enroll the sickest Medicare beneficiaries.

To establish the role of fludarabine (Fludara) in previously untreated patients with low-grade malignant non-Hodgkin’s

WASHINGTON-A new Internet library of clinical practice guidelines enables physicians to quickly examine hundreds of sets of treatment recommendations and to compare and contrast different guidelines. The National Guideline Clearinghouse (www.guideline.gov) went on-line in mid-January. The website was developed by HHS’ Agency for Health Care Policy Research, the American Medical Association, and the American Association for Health Plans. More than 500 clinical practice guidelines were put into the database initially, and others will be added.

ANAHEIM, California-The inefficient burning of fossil fuel, now practiced on a mammoth scale in developing countries worldwide, puts millions of children around the world at risk for the diseases caused by this form of pollution, which include several forms of cancer. In addition, it worsens climate conditions that carry severe health threats for the future.

WASHINGTON-The National Institutes of Health should greatly expand its efforts to determine why minorities and medically underserved populations, including Appalachian whites, have widely varying cancer burdens, compared with the overall US incidence and mortality, a new Institute of Medicine (IOM) report says.

Iodine-131 tositumomab (Bexxar) is a radiolabeled murine IgG2a monoclonal antibody directed against the CD20 antigen on

The role of allogeneic bone marrow transplant (BMT) as a treatment for advanced non-Hodgkin’s lymphoma (NHL) has not been established. Historical limitations tothis approach have included the relatively advanced age of these patients, as well as their extensive treatment prior to BMT. Accordingly, only limited data have been reported about overall and/or disease-free survival in these patients. Depletion of T-cells offers the potential for older patients to undergo allogeneic BMT by reducing complications related to graft-vs-host disease (GVHD), but whether the graft-vs-lymphoma effect would be correspondingly reduced is unknown.

Contamination of the peripheral blood stem-cell (PBSC) graft with lymphoma and residual disease remaining in the patient after high-dose therapy are two potential causes of relapse after autologous transplantation. Using a tumor-specific monoclonal antibody may be one way to purge the stem-cell graft in vivo and increase the efficacy of the preparative regimen. Rituximab (Rituxan) is an IgG1 kappa chimeric mouse/human antibody containing murine light- and heavy-chain variable regions and human gamma 1 heavy-chain and light-chain constant regions. The antibody reacts specifically with the CD20 antigen found on the surface of malignant and normal B-cells.

Fludarabine (Fludara) and cyclophosphamide (Cytoxan, Neosar) are two highly active agents in the treatment of indolent

Campath-1H is a humanized anti-CD52 monoclonal antibody (MoAb) that binds to nearly all B-cell and T-cell lymphomas. We report here the results of a multicenter phase II trial of Campath-1H in patients with low-grade NHL. Fifty patients with advanced, heavily pretreated, low-grade NHL were treated with Campath-1H (30 mg administered as a 2-hour intravenous (IV) infusion 3 times weekly for up to 12 weeks).

HAMBURG, Germany-“The next goal for psychooncology is to stamp out distress,” said Jimmie Holland, MD, chair of the Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center.

BETHESDA, Md-National Cancer Institute director Richard D. Klausner, MD, has taken strong exception to two criticisms leveled at NCI in a recent Institute of Medicine (IOM) report on NIH research programs for minorities and the medically underserved . Dr. Klausner told the National Cancer Advisory Board (NCAB), “there are clearly either misunderstandings or profound philosophical differences.”

Protease inhibitors, routinely used to treat the human immunodeficiency virus (HIV) in the United States, are highly effective against the subtype C viral strain thought to be most prevalent worldwide, report Stanford researchers.

Waldenström’s macroglobulinemia is a rare, low-grade lymphoproliferative disorder for which few therapies are effective. Although patients with Waldenström’s macroglobulinemia often are reported with cases of small lymphocytic lymphoma, this disease has characteristic lymphoplasmacytic histology, bright CD20 expression, and IgM paraproteinemia. Rituximab (Rituxan) is a chimeric anti-CD20 monoclonal antibody that produces a 50% response rate in previously treated low-grade lymphoma, but has no previously described efficacy in the Waldenström’s macroglobulinemia subtype. We report 7 patients with Waldenström’s macroglobulinemia treated on clinical trials performed by IDEC Pharmaceuticals (N = 6) or at our institution (N = 1). Characteristics of these patients included a median age of 60 years (range, 50-75 years) with 5 being female. All patients were symptomatic, with a median performance status of 1 (range, 1-3), with all having measurable disease independent of paraproteinemia.

Our studies have shown that unconjugated antibody therapy targeted to the B-cell marker CD20 by the anti-CD20 antibody, C2B8, inhibits the growth of B-cell lymphomas in vitro. We have also demonstrated that B-lymphoma tumor cells can be sensitized to subtoxic doses of therapeutic drugs by the same antibody.

Several published reports have suggested that although there is a lesser relapse rate for allogeneic bone marrow transplantation (BMT) compared to autologous BMT in patients with low-grade lymphoma, no survival advantage was evident because of higher toxicity associated with allogeneic BMT. To address this issue, we compared outcome in 38 patients with low-grade lymphoma who received allogeneic BMT to 72 patients who underwent autologous BMT at our institution.

Splenomegaly has been considered by some to be a contraindication to monoclonal antibody immunotherapy or

Dr. Nag and colleagues present an excellent review of several of the techniques of brachytherapy used in both the pediatric and adult populations. The authors are to be commended for their comprehensive summary of the results of the major trials of pediatric brachytherapy in the management of soft-tissue sarcomas.

COLLEGEVILLE, Penn-Lovenox (enoxaparin sodium) Injection, from Rhône-Poulenc Rorer Inc., has received FDA approval for the inpatient treatment of acute deep-vein thrombosis (DVT) with or without pulmonary embolism and the outpatient treatment of acute DVT without pulmonary embolism. Both indications require that Lovenox be administered in conjunction with warfarin sodium.

Combination chemotherapy, such as CHOP (cyclophosphamide, doxorubicin HCl, Oncovin, and prednisone), or purine analogs, such as fludarabine (Fludara), are commonly used in the treatment of alkylating agent–resistant, relapsed, low-grade B-cell non-Hodgkin’s lymphoma (NHL). Response rates of around 50% are seen, with median remission duration of 6 to 9 months.

Apanel that included top oncologists at some of the nation’s premier cancer centers criticized the National Cancer Institute(NCI) for not looking behind statistics showing that poor people and ethnic minorities have higher cancer rates in some instances. The Institute of Medicine (IOM), which is part of the National Academy of Sciences, chartered the Committee on Cancer Research Among Minorities and the Medically Underserved. Representatives from the Robert Lurie Cancer Center, Fox Chase Cancer Center, Memorial Sloan-Kettering Cancer Center, and the Stanley S. Scott Cancer Center sat on the committee, which was chaired by M. Alfred Haynes, the former president and dean of the Drew Postgraduate Medical School.

COLUMBUS, Ohio-A trial sponsored by NOAT (Society for Nutritional Oncology Adjuvant Therapy) is examining the effect of eating high-fiber cereal on patients with colon polyps, Daniel Nixon, MD, president of NOAT, said at the group’s 4th Annual Congress.

Actress Jane Seymour, a strong advocate of alternative cancer therapies, was the headlining witness at hearings of the Government Reform Committee held on February 24. Rep. Dan Burton (R-Ind.), chairman of the committee, held the hearings to find out whether federal agencies-be they health care providers, such as Medicare, or research-based, such as the NCI-are aggressive enough in promoting alternative therapies. Those like Burton, who feel that federal agencies have to be more aggressive, support the “Access to Medical Treatment Act,” a bill promoted in the last two Congresses, and again in this one, by Rep. Peter DeFazio (D-OR). DeFazio’s bill had a hearing in 1998 in Burton’s committee, which has no legislative jurisdiction.

We and others have recently confirmed that arsenic trioxide (As2O3) induces a complete remission (CR) in a high proportion of patients

WASHINGTON-In an agreement negotiated by the National Institutes of Health and the American Association of Health Plans, the association says it will encourage its members to “reimburse the routine patient-care costs associated with NIH-sponsored clinical trials, provided those costs are not substantially higher than the costs a plan would incur in the course of standard treatment.”

Rituximab (Rituxan) was recently approved for use in relapsed and previously treated low-grade non-Hodgkin’s lymphoma (NHL); however, little data exist regarding the safety of this agent in patients with hematologic malignancies who have a high number of tumor cells in the blood. We describe our preliminary experience with two such patients in whom we noted a rapid reduction of blood tumor cells, which was associated with severe pulmonary infusion-related toxicity and thrombocytopenia. Two additional patients were collected from physician-submitted reports of adverse events related to rituximab treatment.

With the aim to overcome the limitations of ex vivo bone marrow purging, we have assessed the ability of the anti-CD20 monoclonal antibody rituximab (Rituxan), given in combination with chemotherapy, to eradicate polymerase chain reaction (PCR)–detectable disease, and to enable the harvesting of large amounts of uncontaminated peripheral blood progenitor cells in patients with low-grade lymphoma (in vivo purging). From April 1997 to July 1998, 20 consecutive patients entered the study. Eligibility included age £ 60 years, a diagnosis of untreated mantle cell lymphoma or of refractory/early relapsed follicular lymphoma, CD20 expression by tumor cells, histologic bone marrow infiltration, and availability of a molecular marker for minimal residual disease detection.