AIDS TREATMENT NEWS #188, December 3, 1993
On November 15, AIDS TREATMENT NEWS received an electronic mail message from the researchers about the current studies:
"Please see below for description of the trials. Of note, we have had a number of good responses to Taxol with fairly mild toxicity (slight fatigue, brief myelosuppression, and hair loss). Also, our trial of the novel angiogenesis inhibitor TNP- 470 has caused *no* clear toxicity to date, and the one patient on the highest dose level may be responding to this drug.
"We are intrigued by these early results and would like to enroll these studies as rapidly as possible. However, patients have been scarce, especially for the TNP-470 trial (which is quite time-consuming, with its every-other-day administration schedule)."
All treatment costs are paid by the National Cancer Institute. On the first visit, for screening, volunteers must cover their own travel expenses; later, they will be paid for travel home, or $45 per day when they stay in the Bethesda area. Volunteers often rent rooms from families near the National Institutes of Health campus, which is less expensive than staying in a hotel.
Taxol
"Paclitaxel (Taxol) is a drug derived from the Pacific yew tree that has been found to be effective against ovarian carcinoma. We are presently testing the activity of paclitaxel in a Phase II study in patients with Kaposi's sarcoma. Paclitaxel will be administered as a three hour infusion every 21 days in an outpatient setting. Activity and response will be determined. In addition, the toxicity profile in HIV-positive patients will be identified. Patients must be on a stable regimen of single dose or combination antiretroviral therapy for one month before entry. Patients also must have received no more than one prior regimen of cytotoxic chemotherapy (for the purpose of this protocol, vincristine and vinblastine are considered as a single regimen) and are required to be off chemotherapy, radiation, intralesional therapy and interferon for one month before starting taxol. Patients with pulmonary KS causing substantial symptoms (e.g. dyspnea with minimal exercise) or with other acute, life-threatening KS will be ineligible for this study. For more information, please contact Jill Lietzau at 301-496-8959, or Wayne Saville, M.D., at 301-402-3630."
TNP-470
"TNP-470 is a an analog of the fungal product fumagillin that has been shown to be a potent inhibitor of angiogenesis. It is different from most traditional anti-cancer drugs in that it has caused little or no bone-marrow toxicity or immunosuppression in test animals. The major toxicity in animals (seen when it was given as a bolus) has been bleeding. We are recruiting patients for a Phase I trial with this agent in patients with Kaposi's sarcoma. Patients will receive TNP- 470 every other day for 6 weeks. If the drug is well tolerated, patients will have the option to receive it for up to an additional 12 weeks. Because the drug is given by vein every other day, patients must be from the DC area or must stay in the Maryland/D.C. area for the entire treatment. The toxicity, pharmacokinetics and activity of TNP-470 will be studied. Different patients will receive increasing doses of TNP-470 until the maximum tolerated dose is identified. Patients must be on a stable dose of single-agent or combination antiretroviral therapy for one month before starting TNP, and are required to be off chemotherapy, radiation, intralesional therapy and interferon for three weeks before starting the trial. For more information, please contact Kathy Wyvill or Jill Lietzau at 301-496-8959 or James Pluda, M.D., at (301) 496-1196."
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