PTC299 in Treating Patients With HIV-Related Kaposi Sarcoma (NCT00686842) | Clinical Trial Compass
TerminatedPhase 1/2
PTC299 in Treating Patients With HIV-Related Kaposi Sarcoma
Stopped: Drug supply unavailable.
United States17 participantsStarted 2008-09
Plain-language summary
RATIONALE: PTC299 may stop the growth of Kaposi sarcoma by blocking blood flow to the tumor.
PURPOSE: This phase I/II trial is studying the side effects and best dose of PTC299 and to see how well it works in treating patients with HIV-related Kaposi sarcoma.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Biopsy-proven Kaposi sarcoma (KS) involving the skin (with or without lymph node), oral cavity, gastrointestinal (GI) tract, and/or lung
* Patients with GI and/or pulmonary involvement must be asymptomatic or minimally symptomatic and not require systemic cytotoxic chemotherapy
* Has at least five bidimensionally measurable cutaneous lesions that have not been previously irradiated AND can be used as indicator lesions
* Must have a sufficient number of non-indicator cutaneous lesions measuring ≥ 4 x 4 mm available to obtain a total of four 3-mm punch biopsies (two at baseline and two during the course of study treatment)
* Serologic documentation of HIV infection, as evidenced by positive ELISA, western blot, or other federally approved licensed HIV test OR a detectable blood level of HIV RNA
* Patients receiving antiretroviral therapy for HIV infection are eligible provided they have been on a stable regimen for ≥ 12 weeks prior to study entry AND there is no evidence of improvement in KS during those 12 weeks or there is evidence of progression of KS within the immediate 4 weeks prior to study entry
* No symptomatic visceral KS requiring cytotoxic therapy
PATIENT CHARACTERISTICS:
* Karnofsky performance status 60-100%
* Life expectancy ≥ 3 months
* Absolute neutrophil count ≥ 1,000/mm³
* Platelet count ≥ 75,000/mm³
* Hemoglobin ≥ 8 g/dL
* Creatinine ≤ 2.0 mg/dL
* Total bilirubin normal (grade 0)
* No specific limit of total serum bilir…
What they're measuring
1
Safety and Toxicity of Anti-VEGF Small Molecule PTC299
Timeframe: All study visits
2
Maximum Tolerated Dose
Timeframe: After each group of 3 subjects completes cycle 1 of treatment
3
Response to Treatment
Timeframe: After each 28-day cycle of treatment and at discontinuation of therapy