Status and phase
Conditions
Treatments
About
To assess toxicity and determine the MTD of intravenous TNP-470 administered weekly in patients with AIDS-related Kaposi's sarcoma. To assess pharmacokinetics and tumor response of the drug.
Since evidence shows that neovascularization is important in the development of Kaposi's sarcoma, drugs that inhibit angiogenesis, such as TNP-470, may be of benefit in patients with the disease.
Full description
Since evidence shows that neovascularization is important in the development of Kaposi's sarcoma, drugs that inhibit angiogenesis, such as TNP-470, may be of benefit in patients with the disease.
Patients are entered at 7 escalating dose levels of TNP-470. (PER AMENDMENT 9/3/96: dose maximum level changed.) Four patients treated at a given dose level must receive at least 4 weeks of therapy before escalation in subsequent cohorts proceeds. If 50 percent of patients at a given dose level experience dose-limiting toxicity, the previous dose is defined as the MTD and an additional two patients are treated at the MTD. Patients receive treatment for 12 weeks, followed by 2 weeks of rest, followed by an additional 12 weeks of treatment. Patients are followed for 12 weeks post-treatment.
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
Required in patients with CD4 count < 200 cells/mm3:
Aerosolized pentamidine, trimethoprim/sulfamethoxazole, or dapsone as PCP prophylaxis.
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
PER AMENDMENT 9/3/96:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
PER AMENDMENT 9/3/96:
Prior Medication:
Excluded within 4 weeks prior to study entry:
Excluded within 6 months prior to study entry:
Unwilling to refrain from unprotected sexual contact or other activities that may result in HIV re-infection.
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal