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Updated: Oct 15, 2026
Ex vivo Expansion of Tumor-reactive T Cells by Means of Bryostatin 1/Ionomycin and the Common Gamma Chain Cytokines Formulation
Published on: January 14, 2011
A Phase II trial of bryostatin-1 for patients with metastatic renal cell carcinoma
L Pagliaro1, D Daliani, R Amato
1Department of Genitourinary Medical Oncology, M. D. Anderson Cancer Center, Houston, Texas 77030, USA.
Background:
Patients with metastatic renal cell carcinoma have a poor prognosis and no standard therapy is available. The authors performed a Phase II trial of the novel agent bryostatin-1 in this patient population.
Methods:
In all, 30 patients with measurable, previously untreated metastatic renal cell carcinoma were studied. Patients had excellent physiologic reserve and preserved performance status. Bryostatin-1 (25 microg/m(2)) was given in the PET (polyethyleneglycol, ethanol, and Tween 80) formulation as a 30-minute intravenous infusion on Days 1, 8, and 15 of each 28-day cycle. In general, treatment was continued until disease progression.
Results:
Two patients had significant objective responses, although methodologic problems made interpretation difficult. The median time to progression for all patients was 2.1 months; the median overall survival was 13.1 months. The treatment was generally well tolerated. Myalgia was the most common adverse event. One patient died while on study. This was a sudden death for a patient receiving a 15th cycle of therapy. Aside from this patient (for whom the correlation of study drug to death was not clear), no Grade 4 nonhematologic toxicity was encountered in more than 150 treatment courses delivered.
Conclusions:
There is minimal, if any, clinically relevant single-agent activity of bryostatin-1 at this dose and schedule for patients with metastatic renal cell carcinoma.
Insights
Bryostatin-1 showed minimal activity in metastatic renal cell carcinoma patients. This Phase II trial found limited clinical benefit, with a median progression time of 2.1 months.
Area of Science:
- Oncology
- Clinical Pharmacology
Background:
- Metastatic renal cell carcinoma (mRCC) presents a poor prognosis.
- No standard therapy exists for this patient group.
Purpose of the Study:
- To evaluate the efficacy and safety of bryostatin-1 in patients with metastatic renal cell carcinoma.
Main Methods:
- A Phase II trial involving 30 patients with previously untreated mRCC.
- Bryostatin-1 was administered intravenously at 25 microg/m(2) on Days 1, 8, and 15 of each 28-day cycle.
Main Results:
- Two patients showed objective responses, but interpretation was challenging.
- Median time to progression was 2.1 months; median overall survival was 13.1 months.
- Myalgia was the most common adverse event; the drug was generally well tolerated.
Conclusions:
- Bryostatin-1 demonstrated minimal clinically relevant single-agent activity in this mRCC population.
- The tested dose and schedule showed limited efficacy for metastatic renal cell carcinoma.
