Herzlich willkommen im Forum der Deutschen Hirntumorhilfe!

Thema: Contergan verlangsamt Glioblastom-Wachstum !

Contergan verlangsamt Glioblastom-Wachstum !
Tanja H.
14.06.2001 10:04:49
Wer hätte dies gedacht. Aber lest selbst:

ASCO: Thalomid (Thalidomide) Slows Progression of Renal Cell Carcinoma and Glioblastoma

WARREN, NJ -- May 16, 2001 -- Celgene Corporation announced today that leading oncology teams presented results from twenty-one studies at the 37th Annual Meeting of the American Society of Clinical Oncology (ASCO) evaluating the safety and efficacy of Thalomid® (thalidomide) as a single agent and in combination with conventional therapies for various cancers, including renal cell carcinoma and glioblastoma multiforme.

Clinical data was presented from trials studying Thalomid´s potential as an agent to slow the progression of renal cell carcinoma through anti-cancer and immunomodulatory effects.

"Based on these results, we intend to pursue a major trial designed to evaluate Thalomid as a potential therapy for late stage renal cell carcinoma with time to disease progression and survival as endpoints," said Sol J. Barer, Ph.D., President and Chief Operating Officer of Celgene Corporation.

Researchers from Memorial Sloan-Kettering Cancer Center presented results of a Phase II study of the use of Thalomid monotherapy for patients with metastatic renal cell carcinoma. Twenty-six patients received a starting dose of Thalomid at 200mg/day and escalated by 200mg/day every two weeks as tolerated to a maximum dose of 800mg/day. A maximum dose of 800 mg/day, 600 mg/day, 400 mg/day and 200 mg/day was reached in 5 (19 percent), 10 (38 percent), 8 (31 percent) and 3 (21 percent) patients respectively.

Adverse events witnessed in this investigation were grade 2/3 dyspnea, grade 2/3 neurologic toxicity and grade 2 skin toxicity. In twenty-five evaluable patients, 16 patients (64 percent) achieved stable disease including eight patients (32 percent) who had stable disease for six months or greater. Eighty percent of patients were alive at twelve months.

Researchers from MD Anderson Cancer Center presented findings of a thirty-six patient Phase II clinical study investigating Thalomid´s role in slowing the progression of metastatic renal cell carcinoma. This study evaluated patient response rate and tumor perfusion changes for a median of three cycles (1 cycle = 28 days) of treatment.

Thalomid was given at an initial dose of 200mg/day and increased weekly to a maximum dose of 1200 mg/day if no grade 2 neuropathy was observed. Twenty-nine of the thirty-six patients were evaluated at time of analysis (median time to analysis = 40 weeks). Adverse effects noted were grade 4 sedation and thrombosis; grade 1-3 constipation, anemia, fatigue, dry skin with/without rash, impotence, sedation, paresthesia, dizziness, xerostomia and bradycardia.

Thirty-two percent of patients were progression free: two patients showed partial response and nine patients achieved stable disease.

"Based on these results, we are accelerating the evaluation of thalidomide in renal cell carcinoma in a variety of different studies and at various disease stages and in combination with conventional chemotherapy," said Robert Amato, M.D. of Baylor University.

Renal cell carcinoma is the most common form of kidney cancer and is caused when cells in the lining of the renal tubule undergo cancerous changes. The American Cancer Society estimates that there will be about 30,800 new cases of renal cell carcinoma (18,700 in men and 12,100 in women) in the United States in the year 2001, and about 12,100 people (7,500 men and 4,600 women) will die from this disease.

Investigators from Dana-Farber Cancer Institute and Massachusetts General Hospital published results from a Phase II study of Thalomid in combination with BCNU (carmustine). In this study, Thalomid was combined with BCNU to determine whether anti-tumor activity would be enhanced and if patient survival time would be longer than what may be expected with BCNU as a single agent treatment.

Thalomid dose started at 800 mg/day for two weeks prior to treatment with BCNU (200mg/m(2) every two weeks) and escalated 200mg/day every two weeks to a maximum tolerated dose of 1200 mg/day. Of the forty patients enrolled in this study, thirty-nine patients were assessable for toxicity and thirty-eight were evaluated for a clinical response. Adverse events witnessed during this investigation were grade 4 neutropenia, grade 3 thrombocytopenia and somnolence, deep vein thrombosis with or without pulmonary embolism complications and rash. Three patients discontinued treatment because of rash.

Fifty-eight percent of patients responded, including one complete remission (3 percent), four partial responses (10 percent), one minimal response (3 percent) and sixteen patients achieving stable disease (42 percent). Twenty-five percent of glioblastoma multiforme patients were progression free at six months.

Glioblastoma multiforme is the most aggressive form of the primary brain tumors known collectively as gliomas. These tumors arise from the supporting glial cells of the brain during childhood and in adults. These growths do not spread throughout the body like other forms of cancer, but cause symptoms by invading the brain. Approximately 17,000 people are affected with brain cancer each year, with 13,100 deaths expected in 2001.

Many of the remaining abstracts that were presented examined thalidomide in high-risk patients who had exhausted all conventional treatment options. Investigators involved with these studies suggest that the drug should be examined in clinical trials in patients experiencing earlier stage of disease and/or in combination with other drug regimens.

Thalidomide is contraindicated in pregnant women and women capable of becoming pregnant. Even a single capsule taken by a pregnant woman can cause severe birth defects or death to an unborn baby. To minimize this risk, only prescribers and pharmacies registered with the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.T) distribution program may prescribe or dispense Thalomid. Other adverse drug reactions known to be associated with thalidomide therapy include: peripheral neuropathy, a common, potentially severe side effect that may be irreversible; drowsiness/somnolence; dizziness/orthostatic hypotension; neutropenia; hypersensitivity reactions; and increased HIV-viral load. Physicians should consult full prescribing information about these and other adverse reactions prior to initiating treatment with Thalomid.

SOURCE: Celgene Corporation
Tanja H.