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Phase I clinical trials with fludarabine phosphate
1Department of Medicine, University of Texas Health Science Center, San Antonio 78284.
Seminars in Oncology
|October 1, 1990
Summary
Fludara I.V. (fludarabine phosphate) shows promise in treating certain leukemias and lymphomas, but dose-limiting myelosuppression and severe neurotoxicity limit its use in solid tumors and acute leukemia.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Fludara I.V. (fludarabine phosphate) has undergone multiple Phase I trials for various cancers.
- Investigating efficacy and toxicity across different administration routes and schedules is crucial.
Purpose of the Study:
- To review Phase I trial data for Fludara I.V. in solid tumors and acute leukemia.
- To identify optimal dosing, schedules, and toxicities associated with Fludara I.V. therapy.
Main Methods:
- Analysis of six Phase I trials in solid tumors and three in acute leukemia.
- Evaluation of daily bolus and continuous infusion schedules for solid tumors.
- Assessment of intraperitoneal administration.
Main Results:
- Myelosuppression was the dose-limiting toxicity in solid tumor trials.
- Severe neurotoxicity (dementia, blindness, coma) precluded recommendations for acute leukemia.
- Other toxicities included somnolence, nausea, vomiting, and pneumonitis.
- Profound lymphopenia, a notable side effect, proved beneficial for chronic lymphocytic leukemia, low-grade lymphoma, and mycosis fungoides.
Conclusions:
- Fludara I.V. demonstrates therapeutic potential in specific hematologic malignancies due to its lymphopenic effect.
- Careful consideration of toxicity profiles is essential for patient selection and treatment planning.